| Methods |
Cross‐over RCT
Method of randomisation: computer‐generated randomisation
Blinding of outcome assessors: no
Adverse events: none described
Deaths: none
Dropouts: none
ITT: no |
| Participants |
Country: Japan
12 participants (7 in treatment group, 5 in control group)
All were ambulatory at study onset
Mean age: 62 years
Inclusion criteria: first stroke; more than 6 months since stroke onset; slight‐to‐moderate motor deficit (Brunnstrom recovery stages III–VI); could walk with or without walking aids
Exclusion criteria: higher brain function disorder or cognitive deficit affecting ability to understand and describe symptoms (< 24 on the MMSE); severe heart disorder affecting gait movement intensity; severe bone and joint disease affecting gait movement |
| Interventions |
2 arms (only the first 12 weeks before cross‐over are described here; A: no training, B: gait training with Gait Master 4, 1 session: 20 minutes):
4 weeks A; 2 or 3 times a week, 12 gait training sessions B; 4 weeks A
4 weeks A; 4 weeks A; 4 weeks follow‐up
|
| Outcomes |
Outcomes were recorded weekly over a 24‐week period:
|
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation |
| Allocation concealment (selection bias) |
Unclear risk |
Unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Unclear |