Richards 2004
| Methods | Design: randomised trial of mixed training plus % usual care versus usual care ‐ during usual care Randomisation mechanism: unknown; method: variable blocks stratified on time since stroke, disability, and age Allocation concealment: unknown Blinding: investigator; efficacy unknown ITT: yes Measurements: end of intervention (8 weeks) and 3‐month follow‐up Withdrawals: intervention: 9 (2 discontinued intervention: 1 hip fracture, 1 cardiac problem), 5 unavailable for follow‐up; control: 8 (1 withdrew from intervention, 7 unavailable for follow‐up) |
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| Participants | Randomised: 63 participants Intervention: 32 participants; 22 males and 10 females; age 62.9 years (SD 12); 52 days post‐stroke (SD 22) Control: 31 participants; 21 males and 10 females; age 60.7 years (SD 12); 52.8 days post‐stroke (SD 18) Inclusion criteria: first or second stroke; men or women aged 30 to 89 years; impaired walking; follow verbal instructions; Barthel ambulation score ?10; gait speed of 10 to 60 cm/second Exclusion criteria: cerebral and subarachnoid haemorrhage; major medical problems (cancer, heart conditions, diabetes); receptive or expressive aphasia; lower extremity musculoskeletal disorders affecting gait | |
| Interventions | Intervention: mixed training: task‐oriented gait training programme which used a limb‐load monitor, resisted exercises using a Kinetron, and treadmill walking, intervention occurred during physiotherapy sessions of 60 minutes per day 5 days per week for 8 weeks, progression achieved via velocity and resistance (Kinetron) increments Control: physiotherapy sessions of 60 minutes per day 5 days per week for 8 weeks not including the task‐oriented gait training content above Setting: 2 rehabilitation units | |
| Outcomes | Included outcomes: preferred walking speed; TUG; BI (ambulation subscore); BBS Other outcomes: kinematic gait analysis weakened by missing data in 50% participants; Fugl‐Meyer leg and arm scores | |
| Notes | A second control group of conventional therapy was not used for comparison since (1) it was much shorter in duration, and (2) started later than the training intervention Outcome data imputed from graphs in publication | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unclear; randomisation based on variable blocks stratified on time since stroke, disability, and age |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) All outcomes | High risk | Suitable attention control |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigator blinded |
| Incomplete outcome data (attrition bias) End of intervention | Low risk | ITT analysis 5/63 (8%) losses at the end of intervention; intervention (2 discontinued intervention: 1 hip fracture, 1 cardiac problem); control (1 withdrew from intervention) |
| Incomplete outcome data (attrition bias) End of follow‐up | High risk | ITT analysis 17/63 (27%) total losses at the end of follow‐up; intervention (5 not available); control (7 not available) |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Other bias | Unclear risk | Unclear |
| Imbalanced exposure | Low risk | Balanced exposure |