Terapia ocupacional para adultos con problemas en las actividades de la vida diaria después de un accidente cerebrovascular
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | RCT | |
| Participants | Hong Kong | |
| Interventions | Additional home‐based intervention in the use of bathing devices (n = 30) versus no intervention (n = 23) | |
| Outcomes | Outcomes were recorded at 3 months after discharge Study authors also report: users evaluation of satisfaction with AT | |
| Notes | Funding sources/Declarations of interest: not reported Study dates: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Subjects in need of bathing devices were randomly assigned to the two groups. The occupational therapists, who were involved in the random assignment procedures, were blind to the study's purpose" Insufficient information about the sequence generation process to permit judgement of yes or no |
| Allocation concealment (selection bias) | Unclear risk | "The occupational therapists, who were involved in the random assignment procedures, were blind to the study’s purpose" |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind personnel to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | Method of obtaining data on death not reported; review authors did not believe this would introduce bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcome reported using FIM. Study authors did not state who carried out FIM assessments and whether they were blinded. Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Incomplete outcome data (attrition bias) | Low risk | No apparent loss of data. No reports of attrition due to death |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Other bias | Low risk | No other sources of bias were identified |
| Study characteristics | ||
| Methods | RCT | |
| Participants | UK | |
| Interventions | Rehabilitation at home by occupational therapists versus usual care. Input at 2, 8, 16 and 24 weeks. Intervention based on the model of human occupation. Interventions included: teaching new skills; facilitating more independence in activities of daily living; facilitating return of function; enabling participants to use equipment supplied by other agencies; information provision to participant and carer; referring to or liaison with other agencies. Service provided by a qualified occupational therapist | |
| Outcomes | Outcomes were recorded at 12 months Follow‐up period used in analysis: 12 months | |
| Notes | Funding sources/declarations of interest: 1 author received funding from the Stroke Association Study dates: April 1991 to January 1992 Note: Not explicit that unpaid carers were consented and recruited at baseline. Therefore, we did not perform analysis on carer‐reported outcomes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were randomly allocated to either a control or intervention group. Allocation was carried out by an administrative assistant not otherwise involved with participant care or management, using a predetermined code in individual sealed envelopes; unclear how predetermined code was generated |
| Allocation concealment (selection bias) | Unclear risk | Participants were randomly allocated to either a control or intervention group. Allocation was carried out by an administrative assistant not otherwise involved with participant care or management, using a predetermined code in individual sealed envelopes. The method of concealment was not described in sufficient detail to allow a definite judgement – the use of sealed assignment envelopes was described but it remained unclear whether envelopes were opaque and sequentially numbered |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind participants and personnel to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | "The status (dead or alive) ... was determined at one year post stroke by a research assistant, not otherwise involved with the patients, by contact with the patients' general practitioner." |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: ADL (BI): participant‐reported, completion of postal questionnaire EADL (measured using Nottingham Extended ADL Index): participant‐reported, completion of postal questionnaire; mood or distress scores (measured using Geriatric Depression Scale) participant‐reported, completion of postal questionnaire HRQOL (assessed by Pearlman's 6‐point Quality of Life Scale): participant‐reported, completion of postal questionnaire; carers' quality of life (assessed using Pearlman's 6‐point Quality of Life Scale): carer‐reported, completion of postal questionnaire Follow‐up period used in analysis: 12 months Knowledge of the assigned intervention (see performance bias above, blinding of participants and personnel) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b) |
| Incomplete outcome data (attrition bias) | Low risk | At 1 year, 9/55 of the intervention group were dead and 11/55 of the control group were dead. Of those who were alive, 46/55 of the intervention group and 43/55 of the control group returned their questionnaires. 1 person in the control group moved away and was lost to follow‐up. Missing outcome data balanced in numbers across groups with same reason for missing data |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk'. |
| Other bias | Unclear risk | Significant gender imbalance at baseline. Unclear if gender might influence response to intervention and outcome data |
| Study characteristics | ||
| Methods | RCT | |
| Participants | UK Total number of randomised participants: 44 (note: Drummond 1996 included an additional intervention arm with 21 participants who were supported with leisure activities. Participants in the leisure intervention arm were not included in this review update. See Differences between protocol and review) Exclusion criteria: severe comprehension difficulties i.e. score < 3 on Speech Therapy Boston Diagnostic Aphasic Examination; a documented history of dementia; no English language | |
| Interventions |
| |
| Outcomes | Outcomes were recorded at 3/6 months: Study authors also reported the number and amount of time spent in leisure activities (assessed by Nottingham Leisure Questionnaire) Follow‐up period used in analysis: 6 months Knowledge of the assigned intervention (see performance bias above, blinding of participants and personnel) may have impacted on participant‐reported outcomes and we were unable to judge whether this would have influenced outcome data (Higgins 2011b) | |
| Notes | Funding sources/declarations of interest: funding from the Stroke Association and the Nottingham Fights Stroke Association Study dates: 30 October 1990 to 31 July 1992 Note: data included in the previous review (Legg 2006) were unpublished data from the study authors. We attempted to source the data for the single‐pair wise comparison for this update; the data were no longer available and we were not able to include outcome data for the single intervention arm for all outcomes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "... subjects were randomly allocated to one of the three study groups using restricted randomisation." However, the study authors did not provide sufficient information on the methods used to control the random allocation procedure to permit judgement of 'low risk' or 'high risk' |
| Allocation concealment (selection bias) | Unclear risk | "Sealed envelopes were opened by administrative staff who then indicated to which group a subject was to be assigned." Unclear if assignment envelopes were opaque and sequentially numbered |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind personnel to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | Method of obtaining data on death not reported; review authors did not believe this would introduce bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: ADL (measured by Rivermead ADL self‐care section, unclear if completed by independent assessor using objective observation or participant‐reported (interview or completion of questionnaire) EADL (measured by Nottingham EADL): participant‐reported ‐ unclear if interview or self‐completed questionnaire Mood or distress scores (measured by Wakefield Depression Inventory): participant‐reported: unclear if interview or self‐completed questionnaire HRQOL (measured by Nottingham Health Profile): participant‐reported: unclear if interview or self‐completed questionnaire "At three and six months from the date of discharge, all subjects were visited by an independent assessor who did not know to which group they had been allocated." HRQOL and mood were participant‐reported outcomes. Unclear how ADL and EADL data were obtained e.g. objective observation or participant‐reported (interview or completion of questionnaire) Follow‐up period used in analysis: 6 months Knowledge of the assigned intervention (see blinding of participants and personnel above) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b) |
| Incomplete outcome data (attrition bias) | Low risk | Difficult to work out who was missing from what group and why. However, numbers missing at 6 months, were 1 (group 1) and 3 (group 2) |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk'. Only data for the Nottingham Leisure Questionnaire were presented for each of the groups. There was selective reporting of comparisons of intervention arms for Nottingham EADL, Nottingham Health Profile, and Wakefield Depression Inventory |
| Other bias | Low risk | No other sources of risk were identified |
| Study characteristics | ||
| Methods | RCT | |
| Participants | UK | |
| Interventions |
| |
| Outcomes | Outcomes were recorded at 7 weeks/6 months Study authors also reported: Canadian Occupational Performance Measure, resource use (staff time, hospital readmission, provision of equipment and services) Follow‐up period used in analysis: 6 months | |
| Notes | Funding sources/declarations of interest: funding from Chest Heart and Stroke Scotland. Additional support from Glasgow Royal Infirmary NHS Trust and the Chief Scientist Office, Scottish Office, which funded a research training fellowship for 1 author Study dates: not reported Note: not explicit that unpaid carers were consented and recruited at baseline. Therefore, we did not perform analysis on carer‐reported outcomes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computer‐generated schedule" |
| Allocation concealment (selection bias) | Low risk | "Sequentially‐numbered opaque sealed envelopes" |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind personnel to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | Method of obtaining data on death not reported; review authors did not believe this would introduce bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: EADL (measured by Nottingham Extended Activities of Daily Living); participant‐reported ‐ unclear if interview or self‐completed questionnaire HRQOL (measured by European Quality of Life Questionnaire: EUROQOL); participant‐reported ‐ unclear if interview or self‐completed questionnaire Carer mood (measured by General Health Questionnaire): carer‐reported ‐ unclear if interview or self‐completed questionnaire "The outcome assessor who was blinded to treatment allocation, was based in a separate department from the research therapist." Follow‐up period used in analysis: 12 months Knowledge of the assigned intervention (see blinding of participants and personnel above) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b) |
| Incomplete outcome data (attrition bias) | Low risk | At 6 months, primary outcome data (Nottingham Extended Activities of Daily Living) were available for 60/67 of the intervention group. The reasons for attrition (death, unable to complete assessment) reported At 6 months, primary outcome data were available for 63/71 of the control group. The reasons for attrition (death, unable to complete assessment) reported Missing outcome data balanced in numbers across experimental and comparator groups, with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Other bias | Low risk | No other sources of bias identified |
| Study characteristics | ||
| Methods | RCT | |
| Participants | UK | |
| Interventions |
| |
| Outcomes | Outcomes were recorded at 3 and 6 months | |
| Notes | Funding sources/declarations of interest: financial support from the Stroke Association Study dates: not reported Follow‐up period used in analysis: 6 months Note: not explicit that unpaid carers were consented and recruited at baseline.Therefore, we did not perform analysis on carer‐reported outcomes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants randomly allocated by administration clerk; no further details.Insufficient information about the sequence generation process to permit judgement of 'low risk' or 'high risk' |
| Allocation concealment (selection bias) | Unclear risk | "They were randomly allocated by the clerk using prepared sealed envelopes". Method of concealment not described in sufficient detail to permit judgement – unclear if envelopes were opaque or sequentially numbered |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind personnel to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | Method of obtaining data on death not reported; review authors did not believe this introduced bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: ADL (measured by BI): unclear how outcome data were obtained i.e. by observation, interview or participant‐completed questionnaire EADL (measured by Nottingham Extended Activities of Daily Living): participant‐reported ‐ unclear if interview or self‐completed questionnaire Mood or distress (measured by General Health Questionnaire): participant‐reported ‐ unclear if interview or self‐completed questionnaire Carer mood (measured by General Health Questionnaire completed by carer) "Six months after entry to the study the patients were assessed at home by an independent assessor, who had not been informed which treatment the patients had received. The EADL scale was sent prior to the visit, to be completed by the patient and picked up at interview. The independent assessor administered the Barthel Index and the GHQ" Follow‐up period used in analysis: 6 months Knowledge of the assigned intervention (see blinding of participants and personnel above) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b) |
| Incomplete outcome data (attrition bias) | Low risk | At 6 months, 45/53 of the experimental group returned the questionnaires. Reported reasons for attrition were death (5), in nursing home (1) withdrew consent (2) At 6 months, 38/58 of the comparator group returned the questionnaires. Reported reasons for attrition were death (7), withdrew consent (6), in nursing home (6), in hospital (1) At 6 months, a greater (non‐significant) number of participants in the usual service group were dead or dependent (nursing home) (n = 13) compared with the enhanced group (n = 6) (Chi2 = 2.4, P = 0.1; this result is not significant at P < 0.05). 2/45 in the enhanced group and 6/38 in the usual care withdrew consent. The difference in number of participants who withdrew was not significant (Chi2 = 3.04, P = 0.08; this result is not significant at P < 0.05). Missing outcome data balanced across groups with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Other bias | Low risk | No other sources of bias identified |
| Study characteristics | ||
| Methods | RCT | |
| Participants | UK Total number of randomised participants: 313 (note: Parker 2001 included an additional intervention arm with 153 participants who were supported with leisure activities. Participants in the leisure intervention arm were not included in this review update. See Differences between protocol and review) Median age: 71/72 | |
| Interventions |
| |
| Outcomes | Outcomes were recorded at 6 (primary) and 12 months Relevant review outcomes: performance in ADL (assessed by Barthel Index), performance in EADL (assessed by Nottingham Extended ADL), mood (assessed by General Health Questionnaire‐12 item) Carers' mood (assessed by General Health Questionnaire‐12) The study authors also reported: Nottingham Leisure Questionnaire, the International Stroke Trial outcome, the Oxford Handicap Scale, modified Rankin Scale, London Handicap Scale Outcome evaluations were obtained directly from participants through self‐completed questionnaires Follow‐up period used in analyses: 12 months | |
| Notes | Funding sources/declarations of interest: financial support from NHS Research and Development Programme (Cardiovascular Disease and Stroke), NHS R&D Programme for Health Technology Assessment, and by Lothian Health. Also grant support from NHS R&D (Cardiovascular Disease and Stroke) Study dates: July 1996 to June 1998 Note: not explicit that unpaid carers were consented and recruited at baseline. Therefore, we did not perform analysis on carer‐reported outcomes | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The COSTAR (Collaborative Stroke Audit and Research) telephone randomisation service was used to allocate patients to one of the three groups: leisure, ADL and control. Randomisation stratified by participating centre and a five‐level composite measure of prognosis" |
| Allocation concealment (selection bias) | Low risk | "The COSTAR (Collaborative Stroke Audit and Research) telephone randomisation service was used to allocate patients to one of the three groups: leisure, ADL and control." |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind study participants and treating therapists delivering the intervention to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | "The trial coordinating centre in Nottingham obtained information on death." Not clear where data on death were collected but review authors did not believe this would introduced bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: ADL (assessed by BI): obtained directly from participants through self‐completed postal questionnaire. Carers reported completing 35% of ADL and 33% of control questionnaires EADL (assessed by Nottingham Extended ADL): obtained directly from participants through self‐completed postal questionnaire Mood (assessed by General Health Questionnaire‐12 item): obtained directly from participants through self‐completed postal questionnaire Carers' mood (assessed by General Health Questionnaire‐12): obtained directly from carer through self‐completed postal questionnaire Follow‐up period used in analyses: 12 months "Masking to individual allocation maintained until all outcome information had been collected." Follow‐up period used in analysis: 12 months Knowledge of the assigned intervention (see blinding of participants and personnel above) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b) |
| Incomplete outcome data (attrition bias) | Unclear risk | The principle outcome data assessment point was at 6 months At 6 months, 121/156 of the 'ADL' group allocated to the ADL intervention completed the outcomes assessment. The reasons for attrition reported were death (5%) and non‐response to questionnaires (17%) At 6 months, 126/157 of the control completed the outcome questionnaires. The reasons for attrition reported were death (4%) and non‐response (15%) At 12 months, 106/156 of the 'ADL' group allocated to the ADL intervention completed the outcomes assessment. The reasons for attrition reported were death (10%) and nonresponse to questionnaires (22%) At 12 months, 112/157 of the control completed the outcome questionnaires. The reasons for attrition reported were death (7%) and non‐response (22%) Missing outcome data balanced across groups. Reasons for non‐response at 12 months not reported |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Other bias | Low risk | No other sources of bias identified |
| Study characteristics | ||
| Methods | RCT | |
| Participants | USA All participants admitted to Sister Kenny Rehabilitation Institute (SKRI) Abbott‐Northwestern and United Hospitals between 6 November 2006 and 15 March 2007 who met the inclusion/exclusion criteria were given the opportunity to participate in the study Inclusion criteria: participants had the following characteristics: 1. admitted to SKRI for inpatient rehabilitation after onset of first ever stroke, 2. pre‐discharge FIM scores of ≥ 4, 3. discharged to his or her home, 4. had a family carer who was willing to participate | |
| Interventions |
| |
| Outcomes | Outcomes were recorded at the end of the intervention (5 weeks) Relevant review outcomes: performance in ADL (measured FIM, performance in EADL (measured by Frenchay Activities Index)) The study authors also reported: Caregiver Burden Scale | |
| Notes | Funding sources/declarations of interest: none reported Study dates: 6 November 2006 and 15 March 2007 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Prior to the beginning to the study, the principal investigator used a computer‐based random numbers generator to create two tables of three sets of random numbers (corresponding to the three conditions). One table was used to randomise persons with a Medicare case mix index (CMI) of 101‐105 (lower levels of disability at admission to SKRI) and the other table for persons with a CMI of 106–110 (greater degree of disability at admission to SKRI)." |
| Allocation concealment (selection bias) | High risk | "Once notified that a given patient‐caregiver dyad had consented to participate in the study, the researcher drew a numbered card from an envelope and looked up the number on the appropriate table to determine the condition to which the participant was assigned". Researcher allocating participants could possibly see the next assignment ‐ assignment envelopes used without proper safeguards and use of an open allocation schedule |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind personnel to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | Method of obtaining data on death not reported; review authors did not believe this would introduce bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: ADL (measured by Functional Independence measure): participant‐reported outcomes by interview. EADL (measured by Frenchay Activities Index): participant‐reported outcomes by interview. "Within one‐week of discharge from SKRI, former patient‐caregiver dyads participated in a telephone interview with a member of the research team in which the Functional Independence Measure, a modified version of the Frenchay Activities Index, and the Caregivers Burden Scale were administered. The caller was an SKRI rehabilitation therapist and member of the research team who was blinded to the participants’ group assignment.... These instruments were re‐administered via telephone four‐five weeks later by the same caller to the same person answering the questions at pretest." Follow‐up period used in analysis: 5 weeks Knowledge of the assigned intervention (see blinding of participants and personnel above) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b) |
| Incomplete outcome data (attrition bias) | Low risk | 17 dyads consented to participate. 2 participants did not receive the intervention after randomisation (1 = return to hospital; 1 = difficulties in scheduling visits) – not included in any data collection. Did not state which groups they were randomised to, therefore not clear if this was balanced between groups. Large percentage loss but only very small number of participants, judged to be low risk of attrition bias |
| Selective reporting (reporting bias) | Unclear risk | Study author did not report prospective registration with clinical trials register. Not feasible to judge reporting bias |
| Other bias | Low risk | No other sources of bias identified |
| Study characteristics | ||
| Methods | Cross‐over RCT | |
| Participants | UK | |
| Interventions |
| |
| Outcomes | Outcomes were recorded at 3/6 months Relevant review outcomes: performance in activities of daily living (measured by Rivermead ADL self‐care section); HRQOL (assessed using Nottingham Health Profile). Other reported outcomes included: Nottingham stroke dressing assessment | |
| Notes | Outcome data recorded at 3 months used in analyses i.e. before cross‐over period Funding sources/declarations of interest: financial support from the Stroke Association Study dates: not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement of 'low risk' or 'high risk' |
| Allocation concealment (selection bias) | Unclear risk | The method of concealment was not described to permit judgement of 'low risk' or 'high risk' |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind study participants and treating therapists delivering the intervention to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | Method of obtaining data on death not reported; review authors did not believe this would introduce bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: ADL (measured by Rivermead ADL self‐care section): unclear how outcome data were obtained i.e. by observation, interview, or participant‐completed questionnaire. HRQOL (assessed using Nottingham Health Profile): participant‐reported outcome, unclear if interview or self‐completed questionnaire "At three months and six months both groups of patients were assessed by an independent assessor who was unaware of the group to which the patient had been allocated." Follow‐up period used in analysis: 6 months Knowledge of the assigned intervention (see blinding of participants and personnel above) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b). |
| Incomplete outcome data (attrition bias) | Unclear risk | Number of participants allocated to the AB study arm received treatment A (dressing) first, followed by treatment B (no intervention) – number of participants at end of treatment A and treatment B not explicitly stated. Insufficient information to make a decision of 'high' or 'low' risk of bias |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Other bias | Low risk | No other sources of bias identified |
| Study characteristics | ||
| Methods | RCT | |
| Participants | UK | |
| Interventions |
| |
| Outcomes | Outcomes were recorded at 6 months | |
| Notes | Funding sources/declarations of interest: financial support from the Stroke Association Study dates: February 1994 to March 1998 Follow‐up period used in analysis: 6 months Unpaid carers: not explicit that unpaid carers were consented and recruited at baseline. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Our single‐blind randomised controlled trial. Randomisation was by numbered, sealed, opaque envelopes prepared from random‐number tables." |
| Allocation concealment (selection bias) | Low risk | "Patients were then allocated randomly to occupational therapy or to no intervention (control group). Randomisation was by numbered, sealed, opaque envelopes prepared from random‐number tables." |
| Blinding of participants and personnel (performance bias) | High risk | Not feasible to blind personnel to group allocation due to nature of intervention |
| Blinding (mortality) | Low risk | Method of obtaining data on death not reported; review authors did not believe this would introduce bias |
| Blinding of outcome assessment (detection bias) | Unclear risk | Outcomes assessed: ADL (measured by BI): unclear how outcome data were obtained (i.e. by observation, interview, or participant‐completed questionnaire) NEADL (measured by Nottingham Extended Activities of Daily Living Index): participant‐reported outcome: unclear if interview or self‐completed by participant An independent assessor who was unaware of treatment allocation assessed the participants in their homes Follow‐up period used in analysis: 6 months Knowledge of the assigned intervention (see blinding of participants and personnel above) may have impacted on participant‐reported outcomes and we were unable to judge whether this would influence outcome data (Higgins 2011b) |
| Incomplete outcome data (attrition bias) | Low risk | At 6 months, 84/94 of the experimental group completed the outcomes assessment. The reasons for attrition (withdrew consent, died) reported. At 6 months, 79/91 of the comparator group completed the outcomes assessment. The reasons for attrition (withdrew consent, died) reported. Reasons for missing outcome data unlikely to be related to true outcome |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospective publication of a protocol not reported in the full text. Insufficient information to permit judgement of 'low risk' or 'high risk' |
| Other bias | Low risk | No other sources of bias identified |
ADL: activities of daily living
AT: assistive technology
BI: Barthel Index
CMI: Medicare case mix index
EADL: extended activities of daily living
EUROQOL: European Quality of Life Questionnaire
FIM: Functional Independence Measure
HRQOL: health‐related quality of life
IQR: inter quartile range
NEADL: Nottingham Extended Activities of Daily Living
OT: occupational therapy
RCT: randomised controlled trial
SD: standard deviation
SKRI: Sister Kenny Rehabilitation Institute
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| RCT, occupational therapy intervention, population of stroke participants < 50% | |
| Identified from Cochrane Stroke Group Trials Register, RCT, intervention not performed by occupational therapist | |
| RCT, intervention for people with stroke, rehabilitation programme included physiotherapy and occupational therapy | |
| RCT, intervention for people with stroke, rehabilitation programme performed by a physiotherapist | |
| Occupational therapy intervention for ADL in people with stroke, not RCT | |
| RCT, people with stroke, included an occupational therapist as a supervisor but control group also received an active comparison intervention | |
| RCT, people with stroke, occupational therapy intervention but primary outcome was not ADL, used COPM | |
| RCT, people with stroke, client‐centred self‐care intervention versus ordinary training, therefore comparison of two active occupational therapy interventions. | |
| RCT. people with stroke, occupational therapy + exercise versus exercise, therefore occupational therapy in combination with other treatment versus active comparator | |
| RCT, people with stroke, occupational performance coaching | |
| RCT, intervention for people with stroke: intervention group received occupational therapy, both groups received physiotherapy. Excluded as control group had an active comparator | |
| RCT, people with stroke, rehabilitative training + occupational therapy twice a day versus rehabilitative training. Control group included an active comparator | |
| RCT, people with stroke but focused on walking only, not occupational therapy intervention | |
| RCT, people with stroke, rehabilitation with multidisciplinary team, and also active comparison group | |
| Also called EXTRAS study, RCT, intervention for people with stroke. Extended rehabilitation service which might involve occupational therapist as part of a multidisciplinary team | |
| Previously listed in 'Studies awaiting classification' (Legg 2006). Occupational therapy in nursing homes, therefore not eligible. Study currently included in Fletcher‐Smith 2013 | |
| RCT, intervention for people with stroke, performed by nursing team not occupational therapists | |
| RCT, people with stroke, intervention focused solely on individuals with cognitive impairments after acute stroke | |
| RCT, occupational performance coaching to improve cognitive functioning for people with stroke. Recruited participants with impairment in cognitive functions | |
| Previously listed in 'Studies awaiting classification' (Legg 2006). Unable to access any full publication of this study and abstract had insufficient information to clarify eligibility (abstract from 1997), therefore excluded | |
| Previously listed in 'Studies awaiting classification' (Legg 2006). Unable to access any full publication of this study and abstract had insufficient information to clarify eligibility (abstract from 1997), therefore excluded | |
| RCT, people with stroke, self‐care educational intervention with physiotherapists, not occupational therapist | |
| RCT, compared 2 types of occupational therapy for stroke patients with cognitive impairments. Excluded because it tackled a specific impairment; also comparison of different occupational therapy techniques | |
| RCT, people with stroke. Occupational therapy + home care reablement vs home care reablement, therefore active comparator | |
| RCT, rehabilitation programme for people with stroke. Study authors did not state involvement of occupational therapist | |
| RCT, people with stroke, intervention not performed by an occupational therapist | |
| RCT, people with stroke, intervention included physiotherapy and occupational therapy |
ADL: activities of daily living
COPM: Canadian Occupational Performance Measure
RCT: randomised controlled trial
Characteristics of studies awaiting classification [ordered by study ID]
| Methods | RCT |
| Participants | 164 people with stroke |
| Interventions | Rehabilitation versus control groups |
| Outcomes | Neurological deficit scores Barthel Index |
| Notes | Abstract only. Difficult to ascertain the components of rehabilitation |
| Methods | RCT |
| Participants | 25 people with stroke |
| Interventions | Control and intervention wards. In the intervention wards, self‐care activities were handed over from nursing staff to therapy assistants to practice self‐care activities |
| Outcomes | Motor Activity Log Amount Scale Motor Activity Log How Well Action Research Arm Test (ARAT) Physiotherapy clinical outcome variables Berg Balance Scale Barthel Index |
| Notes | Abstract only. Unclear whether there was any occupational therapy involvement |
| Methods | RCT |
| Participants | 80 people with stroke |
| Interventions | 3 grades regular rehabilitation versus no rehabilitation |
| Outcomes | Fugl‐Myer |
| Notes | Abstract only. Difficult to ascertain the components of 3 grades regular rehabilitation |
ADL: activities of daily living
RCT: randomised controlled trial
Characteristics of ongoing studies [ordered by study ID]
| Study name | Efficacy of participation in daily life promotion program for patients with chronic stroke |
| Methods | RCT |
| Participants | Adults with stroke aged between 20 and 90 years Inclusion criteria:
Exclusion criteria: a clinical diagnosis of:
|
| Interventions | Experimental intervention: daily life promotion programme Comparator intervention: general rehabilitation treatment |
| Outcomes | Primary outcome measures at 1 year: Stroke Impact Scale (SIS) Secondary outcome measures at 1 year: Postural Assessment Scale for Stroke patients (PASS) |
| Starting date | June 2016 |
| Contact information | I Ming Hsiao (PI) [email protected] Yi‐Jiun Yang [email protected] |
| Notes |
| Study name | Effectiveness of FACoT for individuals post stroke |
| Methods | RCT |
| Participants | Inclusion criteria:
Exclusion criteria:
|
| Interventions | Experimental group: FACoT: 10 treatment sessions are provided on a 1‐to‐1 basis. Each treatment session includes: functional activities, cognitive activities and strategies (pencil‐pen treatment), and behavioural strategies Comparator intervention: control group receiving standard care ‐ cognitive and functional assessment |
| Outcomes | Primary outcome measures: Change between baseline (week 0) to time 1 (postintervention, 10 to 13 weeks later) and between baseline to time 2 (follow‐up 1 month later): Canadian Occupational Performance Measure (COPM). Instrumental Activities of Daily Living (IADL) scale |
| Starting date | April 2016 |
| Contact information | Tal Adamit, PHD student: [email protected] Jeffrey Shames: [email protected] |
| Notes |
ARAT: Action Research Arm Test
BI: Barthel Index
BREF: an abbreviated version
COPM: Canadian Occupational Performance Measure
DEX: Dysexecutive Questionnaire
DLSES:The Daily Living Self Efficacy scale
FACoT: Novel Meta‐cognitive‐functional Intervention
FMA: Fugl‐Meyer Assessment
GDS: Geriatric Depression Scale
IADL: instrumental activities of daily living
MoCA: Montreal Cognitive Assessment
NIHSS: National Institutes of Health Stroke Scale
PASS: Postural Assessment Scale for Stroke patients
RCT: randomised controlled trial
RNL: Reintegration to Normal Living Index
SF‐12v2: Short Form‐12v2 Health Survey
SIS: Stroke Impact Scale
TIADL: Taiwan Instrumental Activities of Daily Living
TMT: Trail making test
URICA: University of Rhode Island Change Assessment
WHO: World Health Organization
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Activities of daily living Show forest plot | 7 | 749 | Std. Mean Difference (IV, Fixed, 95% CI) | 0.17 [0.03, 0.31] |
| Analysis 1.1  Comparison 1: Occupational therapy versus no routine input, Outcome 1: Activities of daily living | ||||
| 1.2 Death or 'poor outcome' (deterioration or dependency) Show forest plot | 5 | 771 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.71 [0.52, 0.96] |
| Analysis 1.2  Comparison 1: Occupational therapy versus no routine input, Outcome 2: Death or 'poor outcome' (deterioration or dependency) | ||||
| 1.3 Death by the end of scheduled follow‐up Show forest plot | 8 | 950 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 1.02 [0.65, 1.61] |
| Analysis 1.3  Comparison 1: Occupational therapy versus no routine input, Outcome 3: Death by the end of scheduled follow‐up | ||||
| 1.4 Death or requiring institutional care by the end of scheduled follow up Show forest plot | 4 | 671 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.89 [0.60, 1.32] |
| Analysis 1.4  Comparison 1: Occupational therapy versus no routine input, Outcome 4: Death or requiring institutional care by the end of scheduled follow up | ||||
| 1.5 Death or dependency by the end of scheduled follow‐up Show forest plot | 4 | 659 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.89 [0.64, 1.23] |
| Analysis 1.5  Comparison 1: Occupational therapy versus no routine input, Outcome 5: Death or dependency by the end of scheduled follow‐up | ||||
| 1.6 Extended activities of daily living scores Show forest plot | 5 | 665 | Std. Mean Difference (IV, Fixed, 95% CI) | 0.22 [0.07, 0.37] |
| Analysis 1.6  Comparison 1: Occupational therapy versus no routine input, Outcome 6: Extended activities of daily living scores | ||||
| 1.7 Mood or distress scores Show forest plot | 4 | 519 | Std. Mean Difference (IV, Fixed, 95% CI) | 0.08 [‐0.09, 0.26] |
| Analysis 1.7  Comparison 1: Occupational therapy versus no routine input, Outcome 7: Mood or distress scores | ||||
| 1.8 Sensitivity to missing data (odds of poor outcome: better) Show forest plot | 5 | 857 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.75 [0.56, 1.00] |
| Analysis 1.8  Comparison 1: Occupational therapy versus no routine input, Outcome 8: Sensitivity to missing data (odds of poor outcome: better) | ||||
| 1.9 Sensitivity to missing data (odds of poor outcome: worse) Show forest plot | 5 | 857 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.75 [0.56, 0.99] |
| Analysis 1.9  Comparison 1: Occupational therapy versus no routine input, Outcome 9: Sensitivity to missing data (odds of poor outcome: worse) | ||||
Flow diagram of search conducted in January 2017.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1: Occupational therapy versus no routine input, Outcome 1: Activities of daily living
Comparison 1: Occupational therapy versus no routine input, Outcome 2: Death or 'poor outcome' (deterioration or dependency)
Comparison 1: Occupational therapy versus no routine input, Outcome 3: Death by the end of scheduled follow‐up
Comparison 1: Occupational therapy versus no routine input, Outcome 4: Death or requiring institutional care by the end of scheduled follow up
Comparison 1: Occupational therapy versus no routine input, Outcome 5: Death or dependency by the end of scheduled follow‐up
Comparison 1: Occupational therapy versus no routine input, Outcome 6: Extended activities of daily living scores
Comparison 1: Occupational therapy versus no routine input, Outcome 7: Mood or distress scores
Comparison 1: Occupational therapy versus no routine input, Outcome 8: Sensitivity to missing data (odds of poor outcome: better)
Comparison 1: Occupational therapy versus no routine input, Outcome 9: Sensitivity to missing data (odds of poor outcome: worse)
| Occupational therapy compared to usual or no care for stroke | ||||||
| Patient or population: adults with stroke Intervention: occupational therapy | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Usual or no care | Occupational therapy | |||||
| Activities of daily living at end of scheduled follow‐up. | The mean activities of daily living score was 80.43 | The mean activities of daily living score in the intervention groups was | 749 | ⊕⊕⊝⊝ | A standard deviation of 0.17 represents a small difference between groups | |
| Odds of death or a poor outcome at end of scheduled follow‐up. | Study population | Peto OR 0.71 | 771 | ⊕⊕⊝⊝ | ||
| 440 per 1000 | 313 per 1000 | |||||
| Moderate | ||||||
| Extended Activities of Daily Livingat end of scheduled follow‐up. | The mean Extended Activities of Daily Living score was 33.33 | The mean Extended Activities of Daily Living score in the intervention groups was | 665 | ⊕⊕⊝⊝ | A standard deviation of 0.22 represents a small difference between groups | |
| Mood or distress scores | The mean depression score was 19.83 | The mean mood or distress scores in the intervention groups was | 519 | ⊕⊕⊝⊝ | A standard deviation of 0.08 represents a small difference between groups | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 We downgraded the quality of this evidence one level for serious risk of selection, performance and detection biases (the latter only for subjective outcomes) 2 We further downgraded by one level for serious imprecision (due to small sample sizes, few events and wide confidence intervals). 3 Data taken from a study (Parker 2001) in the meta‐analysis that is representative of the population and intervention and at low risk of bias. | ||||||
| Study | N (I) | n (I) | Dead (I) | Missing (I) | N (C) | n (C) | Dead (C) | Missing (C) |
|---|---|---|---|---|---|---|---|---|
| 30 | 30 | 0 | 0 | 23 | 23 | 0 | 0 | |
| 55 | 46 | 9 | 0 | 55 | 39 | 11 | 5 | |
| 67 | 60 | 6 | 1 | 71 | 62 | 5 | 4 | |
| 53 | 45 | 5 | 3 | 58 | 38 | 7 | 13 | |
| 156 | 106 | 15 | 35 | 157 | 110 | 11 | 36 | |
| 5 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | |
| 15 | 12 | 0 | 3 | 15 | 15 | 0 | 0 | |
| 94 | 84 | 6 | 4 | 91 | 79 | 7 | 5 | |
| C: control group (usual care or no intervention) | ||||||||
| Study | N (I) | n (I) | Dead (I) or deteriorate | Missing (I) | N (C) | n (C) | Dead (C) or deteriorate | Missing (C) |
|---|---|---|---|---|---|---|---|---|
| 55 | 55 | 9 + 24 = 33 | 0 | 55 | 54 | 11 + 21 = 32 | 1 | |
| 53 | 53 | 5 + 1 = 6 | 0 | 58 | 58 | 7 + 7 = 14 | 0 | |
| 67 | 66 | 6 + 27 = 33 | 1 | 71 | 67 | 5 + 36 = 41 | 4 | |
| 156 | 121 | 15 + 36 = 51 | 35 | 157 | 121 | 11 + 45 = 56 | 36 | |
| 94 | 90 | 6 + 12 = 18 | 4 | 91 | 86 | 7 + 20 = 27 | 5 | |
| C: control group (usual care or no intervention) | ||||||||
| Study | N (I) | n (I) | Dead (I) | Missing (I) | N (C) | n (C) | Dead (C) | Missing (C) |
|---|---|---|---|---|---|---|---|---|
| 30 | 30 | 0 | 0 | 23 | 23 | 0 | 0 | |
| 55 | 55 | 9 | 0 | 55 | 55 | 11 | 0 | |
| 67 | 67 | 6 | 0 | 71 | 71 | 5 | 0 | |
| 53 | 53 | 5 | 0 | 58 | 58 | 7 | 0 | |
| 156 | 156 | 15 | 0 | 157 | 157 | 11 | 0 | |
| 5 | 5 | 0 | 0 | 5 | 5 | 0 | 0 | |
| 15 | 15 | 0 | 0 | 15 | 15 | 0 | 0 | |
| 94 | 94 | 6 | 0 | 91 | 91 | 7 | 0 | |
| C: control group (usual care or no intervention) | ||||||||
| Study | N (I) | n (I) | Dead (I) or institutionalised | Missing (I) | N (C) | n (C) | Dead (C) or institutionalised | Missing (C) |
|---|---|---|---|---|---|---|---|---|
| 55 | 55 | 9 + 16 = 25 | 0 | 55 | 54 | 11 + 18 = 29 | 1 | |
| 53 | 53 | 5 + 1 = 6 | 0 | 58 | 58 | 7 + 7 = 14 | 0 | |
| 67 | 67 | 6 + 4 = 10 | 0 | 71 | 71 | 5 + 4 = 9 | 0 | |
| 156 | 156 | 15 + 9 = 24 | 0 | 157 | 157 | 11+9 = 20 | 0 | |
| C: control group (usual care or no intervention) | ||||||||
| Study | N (I) | n (I) | Dead (I) or dependent | Missing (I) | N (C) | n (C) | Dead (C) or dependent | Missing (C) | Measure |
|---|---|---|---|---|---|---|---|---|---|
| 55 | 55 | 9 + 32 = 41 | 0 | 55 | 54 | 11 + 30 = 41 | 1 | Barthel < 15 | |
| 67 | 66 | 6 + 21 = 27 | 1 | 71 | 66 | 6 + 14 = 20 | 5 | Barthel < 15 | |
| 156 | 121 | 15+36 = 51 | 35 | 157 | 121 | 11 + 45 = 56 | 36 | Barthel < 15 | |
| 94 | 90 | 6 + 12 = 18 | 4 | 91 | 86 | 7 + 20 = 27 | 5 | Barthel < 15 | |
| C: control group (usual care or no intervention) | |||||||||
| Study | N (I) | n (I) | Dead (I) | Missing (I) | N (C) | n (C) | Dead (C) | Missing (C) |
|---|---|---|---|---|---|---|---|---|
| 55 | 45 | 9 | 1 | 55 | 39 | 11 | 5 | |
| 67 | 60 | 6 | 1 | 71 | 62 | 5 | 4 | |
| 53 | 45 | 5 | 3 | 58 | 38 | 7 | 13 | |
| 156 | 104 | 15 | 37 | 157 | 109 | 11 | 37 | |
| 5 | 5 | 0 | 0 | 5 | 5 | 0 | 0 | |
| 94 | 84 | 6 | 4 | 91 | 79 | 7 | 5 | |
| C: control group (usual care or no intervention) | ||||||||
| Study | N (I) | n (I) | Dead (I) | Missing (I) | N (C) | n (C) | Dead (C) | Missing (C) |
|---|---|---|---|---|---|---|---|---|
| 67 | 54 | 6 | 7 | 71 | 54 | 5 | 12 | |
| C: control group (usual care or no intervention) | ||||||||
| Study | N (I) | n (I) | Dead (I) | Missing (I) | N (C) | n (C) | Dead (C) | Missing (C) |
|---|---|---|---|---|---|---|---|---|
| 55 | 41 | 9 | 5 | 55 | 31 | 11 | 13 | |
| 53 | 39 | 5 | 9 | 58 | 34 | 7 | 17 | |
| 156 | 105 | 15 | 36 | 157 | 109 | 11 | 37 | |
| 94 | 83 | 6 | 5 | 91 | 77 | 7 | 7 | |
| C: control group (usual care or no intervention) | ||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Activities of daily living Show forest plot | 7 | 749 | Std. Mean Difference (IV, Fixed, 95% CI) | 0.17 [0.03, 0.31] |
| 1.2 Death or 'poor outcome' (deterioration or dependency) Show forest plot | 5 | 771 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.71 [0.52, 0.96] |
| 1.3 Death by the end of scheduled follow‐up Show forest plot | 8 | 950 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 1.02 [0.65, 1.61] |
| 1.4 Death or requiring institutional care by the end of scheduled follow up Show forest plot | 4 | 671 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.89 [0.60, 1.32] |
| 1.5 Death or dependency by the end of scheduled follow‐up Show forest plot | 4 | 659 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.89 [0.64, 1.23] |
| 1.6 Extended activities of daily living scores Show forest plot | 5 | 665 | Std. Mean Difference (IV, Fixed, 95% CI) | 0.22 [0.07, 0.37] |
| 1.7 Mood or distress scores Show forest plot | 4 | 519 | Std. Mean Difference (IV, Fixed, 95% CI) | 0.08 [‐0.09, 0.26] |
| 1.8 Sensitivity to missing data (odds of poor outcome: better) Show forest plot | 5 | 857 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.75 [0.56, 1.00] |
| 1.9 Sensitivity to missing data (odds of poor outcome: worse) Show forest plot | 5 | 857 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.75 [0.56, 0.99] |
