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Quality of life: an important outcome measure in a trial of very early mobilisation after stroke |
Tyedin K, Cumming TB, Bernhardt J |
Disability and Rehabilitation 2010;32(11):875-884 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
PURPOSE: Commencing an early and active mobilisation programme in the acute stages of stroke may have important physical and psychological benefits that might improve long-term quality of life. We hypothesised that patients who received very early mobilisation (VEM) would experience better quality of life than those receiving standard care (SC). METHODS: The study was a phase II single-blind randomised controlled trial: VEM patients received earlier (within 24 h of stroke onset) and more intensive physical therapy than SC patients for the first 14 days (or until discharge). Quality of life was measured using the Assessment of Quality of Life (AQoL) questionnaire, administered face-to-face by a blinded assessor at 12 months post-stroke. RESULTS: Seventy-one individuals with stroke (VEM 38, SC 33) were recruited. At follow-up, the median overall AQoL score was higher in VEM patients (0.32) than SC patients (0.24). This group difference was not significant (p = 0.17), but it was significant at the 75th percentile (p = 0.003) in favour of VEM. VEM patients also reported higher quality of life than SC patients in the physical function related 'Independent Living' domain of the AQoL (p = 0.03 adjusted for age; p = 0.04 adjusted for stroke severity). CONCLUSIONS: VEM may help improve long-term quality of life after stroke, particularly in relation to functional independence, but this requires further examination.
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