English 2015.
Methods | RCT (3 arms) CCT (mobility and upper‐limb) versus usual care (one‐to‐one therapy, 5 days/week) versus 7‐day/week therapy (one‐to‐one). Only CCT and usual care arms included in this review |
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Participants | 283 participants in whole trial (intervention = 93, comparison = 94), mean 29.8 days post‐stroke, mean age 69.1 years, moderate disability (FIM total score of 40‐80 OR motor score of 38‐62) | |
Interventions | Intervention: physiotherapy service provided in twice daily 90‐min CCT sessions, 5 days/week primarily focused on mobility. Included task‐specific, individually progressed exercises focused on improving walking and standing activities Comparision: physiotherapy services based on usual care; primarily provided in individual, one‐to‐one therapy sessions 5 days/week Staff:participant ratio: between 1:3 and 1:6 |
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Outcomes | 6mWT, gait speed, functional ambulation classification, FIM, Stroke Impact Scale, Wolf Motor Function Test, Australian Quality of Life score | |
Notes | Data on therapy time provided and adverse events also available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A computer‐generated randomization sequence was blocked to ensure equal numbers for each arm in each block of 15." |
Allocation concealment (selection bias) | Low risk | "Randomisation was concealed by use of a central telephone service administered by staff not involved in the trial." |
Blinding (performance bias and detection bias) All outcomes | Low risk | No mention of blinding participants or personnel. It would be unlikely that study participants and staff were blinded due to the nature of the trial. Unlikely to influence outcomes: "All outcomes were assessed by a trained assessor who was blinded to group allocation" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Analyses were first conducted with no imputation of missing data (reported)." The study found that when a multiple imputation was applied, it did not significantly influence the results Figure 1 shows a flow of participants including reasons for participants lost to follow‐up. Usual care therapy = 6/94, 7 days/week = 8/96, usual care = 8/93 |
Selective reporting (reporting bias) | Low risk | Protocol available, and all the pre‐specified outcomes were reported Cost‐effectiveness sub‐study to be reported in a different paper |
Other bias | Low risk | No other sources of bias are evident |