Methods | Parallel‐group design Concealed randomisation Outcome assessor was blinded to group allocation | |
Participants | Country: Australia 64 participants in the EXP group and 62 participants in the CTL group Inclusion criteria: within 28 days of their first stroke, between 50 and 85 years of age, hemiparesis or hemiplegia clinically diagnosed, and nonambulatory (defined as scoring 0 or 1 on item 5 (walking) of the Motor Assessment Scale for Stroke) Exclusion criteria: clinically evident brain stem signs, severe cognitive and/or language deficits that precluded them from following instructions, unstable cardiac status or any premorbid conditions that precluded them from rehabilitation 126 stroke patients who were unable to walk were recruited and randomly allocated to an experimental or a control group within 4 weeks of stroke |
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Interventions | Both the EXP and the CTL groups underwent a maximum of 30 minutes per day of walking practice with assistance from 1 therapist for 5 days per week EXP group involved walking on a treadmill supported in a harness: initial body weight support was set so that the knee was within 15 degrees of extension in mid‐stance; initial speed of the treadmill was set so that the therapist had time to assist the leg to swing through while maintaining a reasonable step length CTL group involved assisted overground walking |
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Outcomes | The primary outcome was the proportion of participants achieving independent walking within 6 months Independent walking was defined as being able to walk 15 metres overground barefoot without any aids; participants were tested once per week until they achieved independent walking or were discharged from the rehabilitation unit and were tested again at 6 months |
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Notes | MOBILISE trial | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random permuted (computer‐generated) blocks |
Allocation concealment (selection bias) | Low risk | A central office was used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor was blinded for primary outcome |