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Study flow diagram.

Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Funnel plot of comparison: 1 Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.1 Independent walking at end of intervention phase, all electromechanical devices used.

Figuras y tablas -
Figure 3

Funnel plot of comparison: 1 Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.1 Independent walking at end of intervention phase, all electromechanical devices used.

Funnel plot of comparison: 1 Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.3 Walking velocity (metres per second) at end of intervention phase.

Figuras y tablas -
Figure 4

Funnel plot of comparison: 1 Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), outcome: 1.3 Walking velocity (metres per second) at end of intervention phase.

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 1: Independent walking at end of intervention phase, all electromechanical devices used (primary outcome)

Figuras y tablas -
Analysis 1.1

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 1: Independent walking at end of intervention phase, all electromechanical devices used (primary outcome)

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 2: Independent walking at follow‐up after study end (primary outcome)

Figuras y tablas -
Analysis 1.2

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 2: Independent walking at follow‐up after study end (primary outcome)

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 3: Walking velocity (metres per second) at end of intervention phase

Figuras y tablas -
Analysis 1.3

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 3: Walking velocity (metres per second) at end of intervention phase

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 4: Walking velocity (metres per second) at follow‐up

Figuras y tablas -
Analysis 1.4

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 4: Walking velocity (metres per second) at follow‐up

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 5: Walking capacity (metres walked in 6 minutes) at end of intervention phase

Figuras y tablas -
Analysis 1.5

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 5: Walking capacity (metres walked in 6 minutes) at end of intervention phase

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 6: Walking capacity (metres walked in 6 minutes) at follow‐up

Figuras y tablas -
Analysis 1.6

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 6: Walking capacity (metres walked in 6 minutes) at follow‐up

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 7: Lost to study during intervention phase, dropouts

Figuras y tablas -
Analysis 1.7

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 7: Lost to study during intervention phase, dropouts

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 8: Death from all causes until end of intervention phase

Figuras y tablas -
Analysis 1.8

Comparison 1: Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care), Outcome 8: Death from all causes until end of intervention phase

Comparison 2: Planned sensitivity analysis by trial methods, Outcome 1: Regaining independent walking ability

Figuras y tablas -
Analysis 2.1

Comparison 2: Planned sensitivity analysis by trial methods, Outcome 1: Regaining independent walking ability

Comparison 3: Subgroup analysis comparing participants in acute and chronic phases of stroke, Outcome 1: Independent walking at end of intervention phase, all electromechanical devices used

Figuras y tablas -
Analysis 3.1

Comparison 3: Subgroup analysis comparing participants in acute and chronic phases of stroke, Outcome 1: Independent walking at end of intervention phase, all electromechanical devices used

Comparison 4: Post hoc sensitivity analysis: ambulatory status at start of study, Outcome 1: Recovery of independent walking: ambulatory status at start of study

Figuras y tablas -
Analysis 4.1

Comparison 4: Post hoc sensitivity analysis: ambulatory status at start of study, Outcome 1: Recovery of independent walking: ambulatory status at start of study

Comparison 4: Post hoc sensitivity analysis: ambulatory status at start of study, Outcome 2: Walking velocity: ambulatory status at start of study

Figuras y tablas -
Analysis 4.2

Comparison 4: Post hoc sensitivity analysis: ambulatory status at start of study, Outcome 2: Walking velocity: ambulatory status at start of study

Comparison 5: Post hoc sensitivity analysis: type of device, Outcome 1: Different devices for regaining walking ability

Figuras y tablas -
Analysis 5.1

Comparison 5: Post hoc sensitivity analysis: type of device, Outcome 1: Different devices for regaining walking ability

Comparison 5: Post hoc sensitivity analysis: type of device, Outcome 2: Different devices for regaining walking speed

Figuras y tablas -
Analysis 5.2

Comparison 5: Post hoc sensitivity analysis: type of device, Outcome 2: Different devices for regaining walking speed

Comparison 5: Post hoc sensitivity analysis: type of device, Outcome 3: Different devices for regaining walking capacity

Figuras y tablas -
Analysis 5.3

Comparison 5: Post hoc sensitivity analysis: type of device, Outcome 3: Different devices for regaining walking capacity

Summary of findings 1. Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care) for walking after stroke

Electromechanical‐ and robot‐assisted gait training plus physiotherapy compared to physiotherapy (or usual care) for walking after stroke

Patient or population: patients walking after stroke
Settings: during and after usual care
Intervention: electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No. of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Electromechanical‐ and robot‐assisted gait training plus physiotherapy vs physiotherapy (or usual care)

Independent walking (primary outcome)

At end of intervention phase, all electromechanical devices used
Functional Ambulation Categories (FAC)

Study population

OR 2.01
(1.51 to 2.69)

1572
(38 studies included for this outcome; however, only 18 out of 38 studies contributed to this estimate of the OR)

⊕⊕⊕⊕
Higha,b

451 per 1000

623 per 1000
(553 to 688)

At follow‐up after study end
Functional Ambulation Categories (FAC)

Follow‐up: mean 22.3 weeks

Study population

OR 1.93
(0.72 to 5.13)

496
(6 studies)

⊕⊕⊝⊝
Lowa,c

551 per 1000

703 per 1000
(469 to 863)

Mean walking velocity (secondary outcome; metres per second)

At end of intervention phase
Timed measure of gait
Scale from 0 to infinity

0.5 m/s

0.06 higher
(0.02 to 0.1 higher)

1600
(42 studies)

⊕⊕⊝⊝
Lowa,d

At follow‐up
Timed measure of gait

Scale from 0 to infinity
Follow‐up: mean 19 weeks

0.57 m/s

0.07 higher
(0.03 lower to 0.17 higher)

727
(13 studies)

⊕⊕⊝⊝
Lowa,c

Mean walking capacity (secondary outcome; metres walked in 6 minutes)

At end of intervention phase
Timed measure of gait
Scale from 0 to infinity

172 m

10.86 higher
(5.72 lower to 27.44 higher)

983
(24 studies)

⊕⊕⊕⊝
Moderatea

At follow‐up
Timed measure of gait
Scale from 0 to infinity
Follow‐up: mean 18 weeks

199 m

7.76 higher
(21.47 lower to 36.99 higher)

612
(11 studies)

⊕⊕⊕⊝
Moderatea

Loss to study during intervention phase, dropouts (secondary outcome)
Number of dropouts

Study population

RR ‐0.02 

(‐0.04 to 0.00)

See comment

2440
(62 studies)

⊕⊕⊕⊝
Moderatea

Risks were calculated from pooled risk differences

111 per 1000

94 per 1000
(71 to 111)

Death from all causes until end of intervention phase (secondary outcome)
Number of deaths (from all causes)

Study population

RR 0.00

(‐0.01 to 0.01)

See comment

2440
(62 studies)

⊕⊕⊕⊝
Moderatea

Risks were calculated from pooled risk differences

2 per 1000

3 per 1000

(‐8 to 12)

*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).
CI: confidence interval; OR: odds ratio; RR: risk ratio.

GRADE Working Group grades of evidence.
High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: we are very uncertain about the estimate.

aDowngraded due to several ratings with 'high risk of bias'.
bUpgraded due to large effect of intervention (95% CI does exclude OR = 1.5).
c95% CI includes measure of no effect and minimal clinically important effect.
dDowngraded due to inconsistent results of included studies.

Figuras y tablas -
Summary of findings 1. Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care) for walking after stroke
Table 1. Participant characteristics in studies

Study ID

Experimental:

mean age (SD)

Control:

mean age (SD)

Experimental:

mean time post stroke 

Control:

mean time post stroke

Experimental:

sex

Control:

sex

Experimental:

side paresis

Control:

side paresis

Aschbacher 2006

57 years

65 years

≤ 3 months

≤ 3 months

2 women

4 women

Not stated

Not stated

Aprile 2017

58 (20) years

69 (11) years

> 6 months

> 6 months

4 men, 2 women

5 men, 3 women

0 right, 6 left

5 right, 3 left

Aprile 2019

61 (12) years

56 (9) years

86 days 

44 days 

9 men, 3 women

10 men, 4 women

3 right, 9 left

9 right, 5 left

Bang 2016

54 years

54 years

12 months

13 months

5 men, 4 women

4 men, 5 women

4 right, 5 left

4 right, 5 left

Belas dos Santos 2018

44 (12) years

56 (11) years

5 years

11 years

6 men, 2 women

5 men, 2 women

2 right, 2 left, 3 both

2 right, 2 left, 4 both

Bergmann 2018

72 (9) years

71 (10) years

7.5 weeks

8 weeks

10 men, 5 women

7 men, 8 women

11 right, 4 left

12 right, 3 left

Brincks 2011

61 years

59 years

56 (median) days

21 (median) days

5 men, 2 women

4 men, 2 women

5 right, 2 left

1 right, 5 left

Buesing 2015

60 years

62 years

7 years

5 years

17 men, 8 women

16 men, 9 women

13 right, 12 left

12 right, 13 left

Calabrò 2018

69 (4) years

67 (6) years

10 months

11 months

12 men, 8 women

11 men, 9 women

12 right, 8 left

11 right, 9 left

Chang 2012

56 (12) years

60 (12) years

16 (5) days

18 (5) days

13 men, 7 women

10 men, 7 women

6 right, 14 left

6 right, 11 left

Cho 2015

55 (12) years

55 (15) years

15 months

13 months

Not stated

Not stated

6 right, 4 left, 4 both

3 right, 1 left, 3 both

Chua 2016

62 (10) years

61 (11) years

27 (11) days

30 (14) days

35 men, 18 women

40 men, 13 women

24 right, 29 left

21 right, 32 left

Dias 2006

70 (7) years

68 (11) years

47 (64) months

48 (30) months

16 men, 4 women

14 men, 6 women

Not stated

Not stated

Erbil 2018

50 (11) years

48 (10) years

39 months

25 months

16 men, 13 women

3 men, 11 women

11 right, 18 left

6 right, 8 left

Fisher 2008

Not stated

Not stated

< 12 months

< 12 months

Not stated

Not stated

Not stated

Not stated

Forrester 2014

63 years

60 years

12 days

11 days

Not stated

Not stated

9 right, 9 left

7 right, 9 left

Gandolfi 2019

63 (11) years

64 (10) years
 

54 (36) months
 

53 (41) months
 

10 men, 6 women
 

13 men, 3 women
 

10 right, 6 left

12 right, 4 left

Geroin 2011

63 (7) years

61 (6) years

26 (6) months

27 (6) months

14 men, 6 women

9 men, 1 woman

Not stated

Not stated

Han 2016

68 (15) years

63 (11) years

22 (8) days

18 (10) days

Not stated

Not stated

20 right, 10 left

14 right, 12 left

Hidler 2009

60 (11) years

55 (9) years

111 (63) days

139 (61) days

21 men, 12 women

18 men, 12 women

22 right, 11 left

13 right, 17 left

Hornby 2008

57 (10) years

57 (11) years

50 (51) months

73 (87) months

15 men, 9 women

15 men, 9 women

16 right, 8 left

16 right, 8 left

Husemann 2007

60 (13) years

57 (11) years

79 (56) days

89 (61) days

11 men, 5 women

10 men, 4 women

12 right, 4 left

11 right, 3 left

Jayaraman 2019

59 (9) years

61 (12) years

7 (6) years

5 (3) years

17 men, 8 women

16 men, 9 women

13 right, 12 left

12 right, 13 left

Kayabinar 2019

55 (13) years

63 (10) years

29 (20) months

34 (38) months

20 men, 12 women

21 men, 11 women

31 right, 1 left

29 right, 3 left

Kelley 2013
 

67 (9) years

64 (11) years

4 years

1 year 

64% men

67% men

Not described

Not described

Kim 2015

54 (13) years

50 (16) years

80 (60) days

120 (84) days

9 men, 4 women

10 men, 3 women

8 right, 5 left

10 right, 3 left

Kim 2019a

48 (6) years

46 (14) years

21 (33) months

10 (8) months

9 men, 1 woman

7 men, 2 women

Not stated

Not stated

Kim 2019b

57 (12) years

60 (13) years

2 (2) months

2 (3) months

20 men, 5 women

13 men, 10 women

14 right, 11 left

14 left, 9 right

Kyung 2008

48 (8) years

55 (16) years

22 (23) months

29 (12) months

9 men, 8 women

4 men, 4 women

9 right, 8 left

4 right, 4 left

Kwon 2018

Not stated

Not stated

Stroke at least for 3 months

Stroke at least for 3 months

Not stated

Not stated

Not stated

Not stated

Lee 2019

61 (7) years

62 (6) years

1486 (264) days

1536 (312) days

7 men, 7 women

7 men, 5 women

5 right, 9 left

7 right, 5 left

Lu 2017

50 (13) years

58 (13) years

59 months

28.5 months

23 men, 7 women

21 men, 9 women

13 right, 17 left

15 right, 15 left

Mayr 2008

Not stated

Not stated

Between 10 days and 6 months

Between 10 days and 6 months

Not stated

Not stated

Not stated

Not stated

Mayr 2018

68 (12) years

68 (12) years

5 (1 to 8) weeks

4 (2) weeks

22 men, 15 women

19 men, 18 women

20 right, 17 left

16 right, 21 left

Morone 2011

62 (11) years

62 (14) years

19 (11) days

20 (14) days

15 men, 9 women

13 men, 11 women

13 right, 11 left

15 right, 9 left

Nam 2019

48 (15) years 

68 (17) years

530.11 (389) days

284.81 (309) days

11 men, 7 women 

6 men, 10 women

Not stated

Not stated

Nam 2020
 

60 (11) years

57 (9) years

546 (296) days

600 (506) days

8 men, 10 women

14 men, 6 women

Not stated

Not stated

Noser 2012

67 (9) years

64 (11) years

1354 days

525 days

7 men, 4 women

6 men, 4 women

Not stated

Not stated

Ochi 2015

62 (8) years

66 (12) years

23 (7) days

26 (8) days

11 men, 2 women

9 men, 4 women

6 right, 7 left

5 right, 8 left

Park 2018

56 (7) years

57 (9) years

7 months 

8 months

16 men, 8 women

9 men, 7 women

14 right, 10 left

8 right, 8 left

Peurala 2005

52 (8) years

52 (7) years

2 (2) years

4 (5) years

26 men, 4 women

11 men, 4 women

13 right, 17 left

10 right, 5 left

Peurala 2009

67 (9) years

68 (10) years

8 (3) days

8 (3) days

11 men, 11 women

18 men, 16 women

11 right, 11 left

14 right, 20 left

Picelli 2016

62 (10) years

65 (3) years

6 (4) years

6 (4) years

7 men, 4 women

9 men, 2 women

Not stated

Not stated

Pohl 2007

62 (12) years

64 (11) years

4 (2) weeks

5 (2) weeks

50 men, 27 women

54 men, 24 women

36 right, 41 left

33 right, 45 left

Saltuari 2004

62 (13) years

60 (19) years

3 (4) months

2 (1) months

4 men, 4 women

2 men, 6 women

Not stated

Not stated

Schwartz 2006

62 (9) years

65 (8) years

22 (9) days

24 (10) days

21 men, 16 women

20 men, 10 women

17 right, 20 left

8 right, 22 left

Sczesny‐Kaiser 2019

63 years

66 years

62 months

102 months

3 men, 6 women

2 men, 7 women

4 right, 5 left

4 right, 5 left

Stein 2014

58 (11) years

57 (15) years

49 (39) months

89 (153) months

Not stated

Not stated

Not stated

Not stated

Stolz 2019
 

68 (12) years

63 (16) years

15 (9) days

26 (22) days

8 men, 8 women

14 men, 6 women

7 right, 9 left

11 right, 9 left

Tanaka 2012

63 (10) years

60 (9) years

55 (37) months

65 (67) months

10 men, 2 women

9 right, 3 left

Tanaka 2019

64 (12) years

62 (9) years

103 (28) days

92 (38) days

13 men, 18 women

14 men, 6 women

8 right, 13 left

10 right, 10 left

Taveggia 2016

71 (5) years

73 (7) years

60 (49) days

39 (31) days

7 men, 6 women

10 men, 5 women

Not stated

Not stated

Tomida 2019

55 (9) years

61 (12)

25 (6) days

31 (10) days

11 men, 2 women

5 men, 8 women

6 right, 7 left

5 right, 7 left

Tong 2006

71 (14) years

64 (10) years

2 (1) weeks

2 (1) weeks

19 men, 11 women

12 men, 8 women

13 right, 17 left

7 right, 13 left

Ucar 2014

56 years

62 years

Not stated

Not stated

Not stated

Not stated

Not stated

Not stated

Van Nunen 2012

53 (10) years

2 (1) months

16 men, 14 women

Not stated

Not stated

Waldman 2013

51 (8) years

53 (7) years

41 (20) months

30 (22) months

Not stated

Not stated

Not stated

Not stated

Watanabe 2014

67 (17) years

76 (14) years

59 (47) days

51 (34) days

7 men, 4 women

4 men, 7 women

6 right, 5 left

5 right, 6 left

Werner 2002

60 (9) years

60 (9) years

7 (2) weeks

6 (2) weeks

8 men, 7 women

5 men, 10 women

8 right, 7 left

8 right, 7 left

Westlake 2009

59 (17) years

55 (14) years

44 (27) months

37 (20) months

6 men, 2 women

7 men, 1 woman

4 right, 4 left

3 right, 5 left

Yeung 2018

54 (13) years

61 (10) years

4 (3) years

 6 (4) years

6 men, 3 women

7 men, 3 women

4 right, 5 left

5 right, 5 left

Yun 2018

63 (6) years

64 (3) years

31 (3) years

28 (8) years

10 men, 8 women

9 men, 9 women

3 right, 15 left

4 right, 14 left

SD: standard deviation.

Figuras y tablas -
Table 1. Participant characteristics in studies
Table 2. Demographics of studies including dropouts and adverse events

Criteria
 

Stroke severity
 

Electromechanical device used

Duration of study intervention
 

Aetiology (ischaemic/haemorrhagic)
 

Intensity of treatment per day
 

Description of control intervention
 

Dropouts
 

Reasons for dropout and adverse events in experimental group
 

Reasons for dropout and adverse events in control group
 

Source of information
 

Aprile 2017
 

Not stated
 

G‐EO system
 

45 days, 20 sessions
 

Not stated
 

45 minutes, 3 times a week
 

Traditional gait rehabilitation, 1 hour, 3 times a week
 

0 of 14
 

None

None

Published information
 

Aprile 2019
 

Not stated
 

 G‐EO system

20 sessions
 

8/4
 

45 minutes, 3 times a week
 

Traditional gait rehabilitation, 3 times a week, 20 sessions
 

0 of 26
 

 None

None

Published information

Aschbacher 2006

Not stated

Lokomat

3 weeks

Not stated

30 minutes, 5 times a week

Task‐oriented physiotherapy, 5 times a week for 3 weeks (2.5 hours a week)

4 of 23

Not stated

Not stated

Unpublished information in the form of a conference presentation

Bang 2016

Unclear

Lokomat

4 weeks

13/5

60 minutes, 5 times a week (20 sessions)

Treadmill training without body weight support

0 of 18

None

None

Published information

Belas dos Santos 2018
 

SARA,
18 points

Lokomat

5 months

 4/11

60 minutes, 3 times a week 

Therapist‐assisted gait training, once a week, 60 minutes, for 5 months 
 

4 of 19
 

Participants not complying with protocol treatment criteria in intervention group

Not stated

Published information

Bergmann 2018
 

Not stated
 

Lokomat
 

2 weeks
 

8/7

60 minutes, 8 to 10 sessions in 2 weeks
 

Non‐robotic physiotherapy described as training of postural control including sensory feedback components in sitting, sit‐to‐stand, standing, and walking, if possible, 60 minutes or 30 minutes with 2 therapists, 8 to 10 sessions in 2 weeks 
 

12 of 38 

No pusher behaviour at start of treatment (n = 3),
second stroke (n = 2).
infection (n = 1).
pain lower limb (n = 3).
transfer to another hospital (n = 1)
 

No pusher behaviour at start of treatment
(n = 1),
infection (n = 1)
 

Published information

Calabrò 2018
 

Not stated
 

Ekso
 

8 weeks
 

Not stated
 

45 minutes, 5 days a week
 

Conventional over‐ground gait training
 

0 of 40
 

None
 

None
 

Published information 

Brincks 2011

Mean FIM,
92 points

Lokomat

3 weeks

Not stated

Not stated

Physiotherapy

0 of 13

None

None

Unpublished and published information provided by study authors

Buesing 2015

Unclear

Wearable exoskeleton Stride Management Assist system (SMA)

6 to 8 weeks

Unclear

3 times per week for maximum of 18 sessions

Functional task‐specific training (intensive over‐ground training and mobility training)

0 of  50

None

None

Published information

Chang 2012

Not stated

Lokomat

10 days

Not stated

30 minutes daily for 10 days

Conventional gait training by physical therapists (with equal therapy time and same number of sessions as experimental group)

3 of 40

Not described by group
(3 participants dropped out: 1 due to aspiration pneumonia, 2 were unable to co‐operate fully with experimental procedure)

Unpublished and published information provided by study authors

Cho 2015

Mean modified Barthel Index, 36 points

Lokomat

8 weeks (2 phases, cross‐over after 4 weeks)

4/14 (2 both)

30 minutes, 3 times a week for 4 weeks

Bobath (neurophysiological exercises, inhibition of spasticity and synergy pattern)

0 of 20

None

None

Published information

Chua 2016

Mean Barthel Index, 49 points

Gait Trainer

8 weeks

Not stated

Not stated

Physiotherapy including 25 minutes of stance/gait, 10 minutes cycling, 10 minutes tilt table standing

20 of 106

2 deaths, 3 refusals, 1 medical problem, 1 transport problem
(1 pain as adverse event)

1 death, 6 refusals, 3 medical problems, 1 administrative problem, 2 inability to contact
(no adverse events)

Published information

Dias 2006

Mean Barthel Index, 75 points

Gait Trainer

4 weeks

Not stated

40 minutes, 5 times a week

Bobath method, 5 times a week for 5 weeks

0 of 40

None

None

Unpublished and published information provided by study authors

Erbil 2018
 

Not stated
 

RoboGait
 

3 weeks

28/15
 

90 minutes, 5 days/week 

Physical therapy including stretching, strengthening exercises, proprioception, weight bearing, balance, co‐ordination, and ambulatory training 90 minutes, 5 days/week
 

5 of 48
 

Not stated
 

Not stated
 

Published information
 

Fisher 2008

Not stated

AutoAmbulator

24 sessions

Not stated

Minimum 3 sessions a week up to 5 sessions; number of minutes in each session unclear

Standard physical therapy, 3 to 5 times a week for 24 consecutive sessions

0 of 20

14 adverse events

No details provided

11 adverse events

No details provided

Unpublished and published information provided by study authors

Forrester 2014

Mean FIM
walk, 1 point

Anklebot

8 to 10 sessions (with ca. 200 repetitions)

Not stated

60 minutes, 8 to 10 sessions

Stretching of the paretic ankle

5 of 34

Total of 5 dropouts across both groups (1 medical complication, 1 discharge before study end, 2 times post stroke > 49 days, 1 non‐compliance)

Published information provided by study authors

Gandolfi 2019
 

Mean European Stroke Scale, 72 points;  Barthel Index 90 points

G‐EO system

5 weeks, 10 individual rehabilitation sessions

13/3

45 minutes/2 days per week
 

Sensory Integration Balance Training including over‐ground gait training, stairs up and down, passive lower limb joint mobilisation and stretching exercises same duration as experimental group
 

4 of 32
 

Not stated for both groups
 

Published information
 

Geroin 2011

Mean European Stroke Scale, 80 points

Gait Trainer

2 weeks

Not stated

50 minutes, 5 times a week

Walking exercises according to the Bobath approach

0 of 30

None

None

Unpublished and published information provided by study authors

Han 2016

Not stated

Lokomat

4 weeks

33/23

30 minutes, 5 times a week

Neurodevelopmental techniques for balance and mobility

4 of 60

None

4 unclear reasons

Published information provided by study authors

Hidler 2009

Not stated

Lokomat

8 to 10 weeks (24 sessions)

47/16

45 minutes, 3 days a week

Conventional gait training, 3 times a week for 8 to 10 weeks (24 sessions), each session lasted 1.5 hours

9 of 72

Not described by group
(9 withdrew or were removed because of poor attendance or a decline in health, including 1 death, which according to study authors was unrelated to study)

Unpublished and published information provided by study authors

Hornby 2008

Not stated

Lokomat

12 sessions

22/26

30 minutes,
12 sessions

Therapist‐assisted gait training, 12 sessions, each session lasted 30 minutes

14 of 62

4 participants dropped out (2 discontinued secondary to leg pain during training, 1 experienced pitting oedema, and 1 had travel limitations)

10 participants dropped out
(4 discontinued secondary to leg pain, 1 experienced injury outside therapy, 1 reported fear of falling during training, 1 presented with significant hypertension, 1 had travel limitations, and 2 experienced subjective exercise intolerance)

Published information provided by study authors

Husemann 2007

Median Barthel Index, 35 points

Lokomat

4 weeks

22/8

30 minutes, 5 times a week

Conventional physiotherapy, 30 minutes per day for 4 weeks. Information as provided by study authors

2 of 32

1 participant enteritis

1 participant pulmonary embolism

Published information

Not stated
 

Honda Stride Management Assist
 

6 to 8 weeks
 

33/17
 

45 minutes per session, 3 times per week 
 

Over‐ground gait training, functional task‐specific training
 

4 of 54
 

2 transportation problems 

 

2 transportation problems 

 

Information as provided by study authors
 

Kayabinar 2019
 

Not stated
 

Robot‐assisted device

5 weeks
 

Not stated
 

40 minutes, 
15 sessions of training, 3 times per week
 

Conventional gait training 40 minutes, 3 days per week
 

2 of 66
 

1 early discharge
 

1 early discharge

Information as provided by study authors
 

Kelley 2013
 

Not stated

Lokomat

8 weeks

Not stated

60 minutes, 5 times a week

Over‐ground gait training by physiotherapy on level and uneven surfaces

1 of 21

None

1 withdrew

Information as provided by study authors

Kim 2015

Mean Barthel Index, 20 points

Walkbot

4 weeks

13/13

30 minutes, 5 times a week

Conventional physiotherapy (bed mobility, stretching, balance training, strengthening, symmetry training, treadmill training)

4 of 30

1 rib fracture, 3 decline in health condition

Information as provided by study authors

Kim 2019a
 

Not stated

Lokomat

4 weeks

Not stated

60 minutes,
20 sessions

Conventional physical therapy (CPT)

2 of 19

1 withdrew

1 withdrew

Published information

Kim 2019b
 

Mean Barthel Index, 55  points

Morning Walk

3 weeks

16/32

1.5 hours per session, 5 times per week 

Conventional physiotherapy

10 of 58

1 medical complication

1 unstable mood

1 isolation

7 early discharge

Published information

Kwon 2018

Not stated

Exowalk

4 weeks

Not stated

30 minutes a day, 5 days a week

Physical therapist‐assisted gait training

0 of  41

None

None

Published information

Kyung 2008

Not stated

Lokomat

4 weeks

18/7

45 minutes, 3 days a week

Conventional physiotherapy, received equal time and sessions of conventional gait training

10 of 35

1 participant dropped out for private reasons (travelling); adverse events not described

9 participants refused after randomisation (reasons not provided); adverse events not described

Unpublished and published information provided by study authors

Lee 2019
 

Not stated

Gait Enhancing and Motivating System

4 weeks

18/8

45 minutes, 3 times per week, 10 sessions

Gait training without Gait Enhancing and Motivating System

2 of 28

None

2 withdrew

Published information

Mayr 2008

Not stated

Lokomat

8 weeks

Not stated

Not stated

Add‐on conventional physiotherapy, received equal time and sessions of conventional gait training

13 of 74

4 participants dropped out (reasons not provided); adverse events not described

9 participants dropped out (reasons not provided)

Unpublished and published information provided by study authors

Mayr 2018
 

Not stated

Lokomat

8 weeks

Not stated

2 hours, 5 times a week

Conventional over‐ground physical therapy

8 of 74

7 change in clinical condition

5 change in clinical condition,

2 lack of compliance

Published information

Morone 2011

Canadian Neurological Scale, 6 points

Gait Trainer

4 weeks

41/7

40 minutes, 5 times a week

Focused on trunk stabilisation, weight transfer to paretic leg, and walking between parallel
bars or on the ground. Participant was helped by 1 or 2 therapists and walking aids if necessary

21 of 48

12 (hypotension, referred weakness, knee pain, urinary infection, uncontrolled blood pressure, fever, absence of physiotherapist)

9 (hypotension, referred weakness, knee pain, ankle pain, uncontrolled blood pressure, fever, absence of physiotherapist)

Information as provided by study  authors

Nam 2019
 

Mean Barthel Index, 16 points

Exowalk

4 weeks

20/14

30 minutes, 5 days a week

Physical therapist‐assisted gait training by conventional method

6 of 40

6 did not complete gait training
because of individual schedule

Published information

Nam 2020
 

Not stated

Exowalk

2 weeks
 

25/13

60 minutes, 5 days a week 

Physical therapist‐assisted gait training

2 of 40
 

2 personal reasons

None

Published information

Noser 2012

Not stated

Lokomat

Unclear

Not stated

Not stated

Not stated

1 of 21

No dropouts;

2 serious adverse events (1 skin breakdown as a result of therapy, 1 second stroke during post‐treatment phase)

1 dropout due to protocol violation;
2 serious adverse events (1 sudden drop in blood pressure at participant's home leading to brief hospitalisation; 1 sudden chest pain before therapy leading to brief hospitalisation)

Information as provided by study  authors

Ochi 2015

Not stated

Gait‐assistance robot (consisting of 4 robotic arms for thighs and legs, thigh cuffs, leg apparatuses, and a treadmill)

4 weeks

10/16

20 minutes, 5 times a week for 4 weeks, in addition to rehabilitation treatment

Range‐of‐motion exercises, muscle strengthening, rolling over and sit‐to‐stand and activity and gait exercises

0 of 26

None

None

Published information

Park 2018
 

Mean modified Barthel Index, 55 points

Lokomat Pro

6 weeks

20/20

45 minutes, 3 times a week

General gait training using a treadmill

0 of 40
 

None

None

Published information

Peurala 2005

Scandinavian Stroke Scale, 42 points

Gait Trainer

3 weeks

25/20

20 minutes, 5 times a week for 3 weeks, in addition to rehabilitation treatment

Walking over‐ground; all participants practised gait for 15 sessions over 3 weeks (each session lasted 20 minutes)

0 of 45

None

None

Published information

Peurala 2009

Not stated

Gait Trainer

3 weeks

42/14

20 minutes, 5 times a week for 3 weeks, in addition to rehabilitation treatment

Over‐ground walking training; in the other control group, 1 or 2 physiotherapy sessions daily but not at the same intensity as in the other groups

 

9 of 56

5 dropouts
(2 situation worsened after 1 to 2 treatment days; 1 had 2 unsuccessful attempts with device; 1 had scheduling problems; 1 felt protocol too demanding)

4 dropouts
(1 felt protocol too demanding; 2 situation worsened after 1 to 2 treatment days; 1 death)

Published information

Picelli 2016

Not stated

G‐EO system evolution

30 minutes a day for 5 consecutive days

Not stated

5 days in addition to botulinum toxin injection of calf muscles

None

0 of 22

None

None

Published information

Pohl 2007

Mean Barthel Index, 37 points

Gait Trainer

4 weeks

124/31

20 minutes, 5 times a week

Physiotherapy every weekday for 4 weeks

11 of 155

2 participants refused therapy,

1 increased cranial pressure,

1 relapsing pancreas tumour,

1 cardiovascular unstable

4 participants refused therapy, 1 participant died,1 myocardial infarction

Published information

Saltuari 2004

Not stated

Lokomat

2 weeks

13/3

A‐B‐A study: in phase A, 30 minutes, 5 days a week

Physiotherapy every weekday for 3 weeks (phase B)

0 of 16

None

None

Unpublished and published information provided by study authors.

Schwartz 2006

Mean NIHSS, 11 points

Lokomat

6 weeks

49/67

30 minutes, 3 times a week

Physiotherapy with additional gait training 3 times a week for 6 weeks

6 of 46

2 participants with leg wounds,

1 with recurrent stroke,

1 refused therapy

1 participant with recurrent stroke,

1 with pulmonary embolism

Unpublished and published information provided by study authors.

Sczesny‐Kaiser 2019
 

Mean Barthel Index, 91 points

Hybrid assistive limb

6 weeks

14/4

30 minutes, 5 times a week, 30 sessions

Conventional physiotherapy

0 of 18

None

None

Published Information

Stein 2014

Not stated

Bionic leg device
(AlterG)

6 weeks

Not stated

1 hour, 3 times a week for 6 weeks

Group exercises

0 of 24

None

None

Published information

Stolz 2019
 

Mean FIM, 51 points

Robowalk

3 months

29/7

30 minutes, 5 days a week

Conventional physiotherapy

4/40

None

2 medically unstable

2 withdrew

Published information

Tanaka 2012

Mean FIM, 79 points

Gait Master4

4 weeks

Not stated

20 minutes, 2 or 3 times a week (12 sessions)

Non‐intervention (non‐training)

0 of 12

None

None

Published information

Tanaka 2019
 

Not stated
 

Stride Management Assist
 

10 consecutive days
 

29/12
 

1 to 2 hours with 10 minutes or longer including RAGT
 

Conventional gait training
 

5/41
 

1 participant had trouble with leg brace;
2 participants for personal reasons

2 participants for personal reasons
 

Published information
 

Taveggia 2016
 

Mean NIHSS 7 points

Lokomat

5 weeks

Not stated

30 minutes, 5 sessions a week

Conventional gait training

0 of 28

None

None

Published information

Tomida 2019
 

Not stated
 

GEAR system
 

4 weeks
 

6/20
 

40 minutes, 7 times a week

Conventional gait training

None
 

None
 

None
 

Published information
 

Tong 2006

Mean Barthel Index, 51 points

Gait Trainer

4 weeks

39/11

20 minutes, 5 times a week

Conventional physiotherapy alone, based on Bobath concept

4 of 50

None

2 participants discharged before study end,

1 participant readmitted to an acute ward,

1 participant deteriorating condition

Published information

Ucar 2014

Not stated

Lokomat

2 weeks

Not stated

30 minutes, 5 times a week

Conventional physiotherapy at home (focused on gait)

0 of 22

None

None

Published information

Van Nunen 2012

Not stated

Lokomat

8 weeks

Not stated

30 minutes, twice a week

Over‐ground walking therapy

0 of 30

None

None

Unpublished and published information provided by study authors

Waldman 2013

Not stated

Portable rehab robot (ankle device)

6 weeks

Not stated

3 times a week, 18 sessions

Stretching plantar flexors and active exercises for ankle mobility and strength

0 of 24

None

None

Published information

Watanabe 2014

Not stated

Single‐leg version of Hybrid Assistive Limb (HAL)

4 weeks

11/11

20 minutes,
12 sessions

Aimed to improve walking speed, endurance, balance, postural stability, and symmetry

10 of 32

4 withdrew,

1 epilepsy,

1 technical reasons

2 pneumonia,

2 discharged

Published information

Watanabe 2017
 

Not stated

Robot Suit Hybrid Assistive Limb (HAL)

4 weeks

7/5 only intervention group, control group not stated

3 times a week, minutes not stated

Conventional gait training

10 of 33

4 withdrew

1 medical problem

1 technical reasons

2 medical reasons

2 early discharged

Published information

Werner 2002

Mean Barthel Index, 38 points

Gait Trainer

2 weeks

13/12

20 minutes, 5 times a week

Gait therapy including treadmill training with body weight support

0 of 30

None

None

Published information

Westlake 2009

Not stated

Lokomat

4 weeks (12 sessions)

8/8

30 minutes, 3 times a week

12 physiotherapy sessions including manually guided gait training (3 times a week over 4 weeks)

0 of 16

None

None

Published information

Yeung 2018
 

Not stated

Exoskeleton ankle robot

5 weeks 

14/5

30 minutes,
20 sessions

Gait training with passive ankle foot orthosis

0 of 19

None

None

Published information

Yun 2018
 

Mean NIHSS, 12 points

Lokomat

3 weeks 

11/25

30 minutes per day, 5 days a week

Conventional physical therapy  based on neurodevelopmental techniques developed by Bobath and the physiotherapy proposed by Karnath
 

2 of 19

1 recurrent stroke

1 pneumonia

Published information

FIM: Functional Independence Measure.
NIHSS: National Institutes of Health Stroke Scale.
SARA: Scale for Assessment and Rating of Ataxia.

Figuras y tablas -
Table 2. Demographics of studies including dropouts and adverse events
Comparison 1. Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Independent walking at end of intervention phase, all electromechanical devices used (primary outcome) Show forest plot

38

1567

Odds Ratio (M‐H, Random, 95% CI)

2.14 [1.57, 2.92]

1.2 Independent walking at follow‐up after study end (primary outcome) Show forest plot

6

496

Odds Ratio (M‐H, Random, 95% CI)

1.93 [0.72, 5.13]

1.3 Walking velocity (metres per second) at end of intervention phase Show forest plot

42

1600

Mean Difference (IV, Random, 95% CI)

0.06 [0.02, 0.10]

1.4 Walking velocity (metres per second) at follow‐up Show forest plot

13

727

Mean Difference (IV, Random, 95% CI)

0.07 [‐0.03, 0.17]

1.5 Walking capacity (metres walked in 6 minutes) at end of intervention phase Show forest plot

24

983

Mean Difference (IV, Random, 95% CI)

10.86 [‐5.72, 27.44]

1.6 Walking capacity (metres walked in 6 minutes) at follow‐up Show forest plot

11

612

Mean Difference (IV, Random, 95% CI)

7.76 [‐21.47, 36.99]

1.7 Lost to study during intervention phase, dropouts Show forest plot

62

2440

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.04, 0.00]

1.7.1 All studies using end‐effector devices

14

716

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.05, 0.02]

1.7.2 All studies using exoskeleton devices

41

1496

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.05, 0.00]

1.7.3 All studies using mobile devices

4

146

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.05, 0.06]

1.7.4 All studies using ankle devices

3

82

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.09, 0.11]

1.8 Death from all causes until end of intervention phase Show forest plot

62

2440

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.01]

Figuras y tablas -
Comparison 1. Electromechanical‐ and robot‐assisted gait training plus physiotherapy versus physiotherapy (or usual care)
Comparison 2. Planned sensitivity analysis by trial methods

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

2.1 Regaining independent walking ability Show forest plot

38

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1.1 All studies with adequate sequence generation process

22

1049

Odds Ratio (M‐H, Random, 95% CI)

1.93 [1.26, 2.96]

2.1.2 All studies with adequate concealed allocation

18

905

Odds Ratio (M‐H, Random, 95% CI)

1.90 [1.23, 2.95]

2.1.3 All studies with blinded assessors for primary outcome

17

836

Odds Ratio (M‐H, Random, 95% CI)

1.86 [1.22, 2.84]

2.1.4 All studies without incomplete outcome data

14

590

Odds Ratio (M‐H, Random, 95% CI)

2.23 [1.16, 4.29]

2.1.5 All studies excluding the largest study ‐ Pohl 2007

37

1417

Odds Ratio (M‐H, Random, 95% CI)

1.74 [1.26, 2.39]

Figuras y tablas -
Comparison 2. Planned sensitivity analysis by trial methods
Comparison 3. Subgroup analysis comparing participants in acute and chronic phases of stroke

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

3.1 Independent walking at end of intervention phase, all electromechanical devices used Show forest plot

38

Odds Ratio (IV, Random, 95% CI)

Subtotals only

3.1.1 Acute phase: less than or equal to 3 months after stroke

22

1243

Odds Ratio (IV, Random, 95% CI)

1.96 [1.47, 2.62]

3.1.2 Chronic phase: more than 3 months after stroke

16

461

Odds Ratio (IV, Random, 95% CI)

1.20 [0.40, 3.65]

Figuras y tablas -
Comparison 3. Subgroup analysis comparing participants in acute and chronic phases of stroke
Comparison 4. Post hoc sensitivity analysis: ambulatory status at start of study

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

4.1 Recovery of independent walking: ambulatory status at start of study Show forest plot

38

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1.1 Studies that included independent walkers

15

500

Odds Ratio (M‐H, Random, 95% CI)

1.38 [0.45, 4.20]

4.1.2 Studies that included dependent and independent walkers

9

340

Odds Ratio (M‐H, Random, 95% CI)

1.90 [1.11, 3.25]

4.1.3 Studies that included dependent walkers

14

732

Odds Ratio (M‐H, Random, 95% CI)

2.02 [1.27, 3.22]

4.2 Walking velocity: ambulatory status at start of study Show forest plot

40

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.2.1 Studies that included independent walkers

22

715

Mean Difference (IV, Random, 95% CI)

0.02 [‐0.04, 0.09]

4.2.2 Studies that included dependent and independent walkers

7

226

Mean Difference (IV, Random, 95% CI)

0.04 [‐0.04, 0.11]

4.2.3 Studies that included dependent walkers

11

591

Mean Difference (IV, Random, 95% CI)

0.09 [0.02, 0.15]

Figuras y tablas -
Comparison 4. Post hoc sensitivity analysis: ambulatory status at start of study
Comparison 5. Post hoc sensitivity analysis: type of device

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

5.1 Different devices for regaining walking ability Show forest plot

34

Odds Ratio (M‐H, Random, 95% CI)

Subtotals only

5.1.1 All studies using end‐effector devices

11

598

Odds Ratio (M‐H, Random, 95% CI)

1.90 [0.99, 3.63]

5.1.2 All studies using exoskeleton devices

18

685

Odds Ratio (M‐H, Random, 95% CI)

2.11 [1.36, 3.29]

5.1.3 All studies using mobile devices

3

106

Odds Ratio (M‐H, Random, 95% CI)

Not estimable

5.1.4 All studies using ankle devices

2

63

Odds Ratio (M‐H, Random, 95% CI)

Not estimable

5.2 Different devices for regaining walking speed Show forest plot

41

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.2.1 All studies using end‐effector devices

13

665

Mean Difference (IV, Random, 95% CI)

0.12 [0.05, 0.19]

5.2.2 All studies using exoskeleton devices

23

742

Mean Difference (IV, Random, 95% CI)

‐0.00 [‐0.05, 0.04]

5.2.3 All studies using mobile devices

4

146

Mean Difference (IV, Random, 95% CI)

0.12 [‐0.07, 0.30]

5.2.4 All studies using ankle devices

2

58

Mean Difference (IV, Random, 95% CI)

0.11 [‐0.10, 0.31]

5.3 Different devices for regaining walking capacity Show forest plot

24

983

Mean Difference (IV, Random, 95% CI)

10.86 [‐5.72, 27.44]

5.3.1 All studies using end‐effector devices

7

416

Mean Difference (IV, Random, 95% CI)

31.22 [10.35, 52.08]

5.3.2 All studies using exoskeleton devices

13

468

Mean Difference (IV, Random, 95% CI)

‐8.32 [‐27.73, 11.08]

5.3.3 All studies using mobile devices

2

56

Mean Difference (IV, Random, 95% CI)

20.06 [‐39.52, 79.63]

5.3.4 All studies using ankle devices

2

43

Mean Difference (IV, Random, 95% CI)

49.23 [‐17.09, 115.55]

Figuras y tablas -
Comparison 5. Post hoc sensitivity analysis: type of device