Werner 2002
| Methods | Cross‐over RCT Method of randomisation: participants randomly assigned to groups (group allocation in envelopes that were drawn by an independent person) Blinding of outcome assessors: yes Adverse events: none Deaths: none Drop‐outs: none ITT: yes | |
| Participants | Country: Germany 30 participants (15 in treatment group, 15 in control group) Non‐ambulatory at study onset Mean age: 60 years Inclusion criteria: first stroke, supratentorial lesion 4 to 12 weeks post‐stroke, younger than 75 years of age, not able to walk (Functional Ambulation Category of 2 or less), able to sit unsupported on the edge of a bed, able to stand for at least 10 seconds with help, able to provide and did provide written informed consent Exclusion criteria: hip and knee extension deficit > 20 degrees; passive dorsiflexion of the affected ankle to less than a neutral position; severe impairment of cognition or communication; evidence of cardiac ischaemia, arrhythmia, decompression or heart failure; feeling of 'overexertion' or heart rate exceeding the age‐predicted maximum (i.e. 190 beats/minute minus age) during training; resting systolic blood pressure exceeding 200 mm Hg at rest or dropping by more than 10 mm Hg with increasing workload | |
| Interventions | 2 arms:
Treated as inpatients for 5 15‐ to 20‐minute sessions per week for 2 weeks A: treadmill training with body weight support: participants walked on a treadmill with partial body weight support provided by a harness B: gait trainer with body weight support: participants walked on a Gait Trainer with partial body weight support provided by a harness |
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| Outcomes | Outcomes were recorded at baseline and after 2 weeks (additionally after 4 and 6 weeks, but only the first phase was included in this review):
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| Notes | We used the first treatment phase only Published and unpublished data provided by the authors 0% drop‐outs at the end of first treatment phase (data were analysed as ITT) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | By envelopes |
| Allocation concealment (selection bias) | Low risk | Concealed envelopes that were drawn by an independent person |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Yes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |