How to design clinical rehabilitation trials for the upper paretic limb early post stroke?

Table 2 Results sample size calculation: various time intervals from stroke onset to the moment of randomization (N = 157)

Time interval	Group 1 Mean ± SD	Group 0 Mean ± SD	SD pooled	Variance	Sample size
FMA-UE
T₀ to 1 week	18.09 ± 19.78	15.62 ± 17.06	18.47	341	275
T₀ to 3 weeks	22.19 ± 21.86	21.23 ± 20.07	20.98	440	352
T₀ to 5 weeks	28.89 ± 23.42	24.27 ± 21.66	22.56	509	405
T₀ to 8 weeks	24.54 ± 22.91	25.80 ± 22.36	22.64	512	409
T₀ to12 weeks	26.18 ± 24.19	28.69 ± 22.61	23.42	548	438
ARAT
T₀ to 1 week	8.24 ± 12.82	7.33 ± 12.89	12.85	165	178
T₀ to 3 weeks	11.70 ± 16.76	11.15 ± 15.96	16.36	268	288
T₀ to 5 weeks	13.58 ± 17.67	13.77 ± 17.95	17.81	317	341
T₀ to 8 weeks	15.65 ± 19.76	15.14 ± 19.02	19.39	376	403
T₀ to 12 weeks	17.95 ± 21.49	15.46 ± 18.34	19.98	399	429

Sample sizes are the total number of patients required, including 10 % to account for dropouts. Individual patients were randomly selected at different time points post stroke onset, where after this assessment was considered as their baseline assessment. Mean and SD are derived from the full dataset, after individual curve fitting. ARAT Action Research Arm Test (score = 0–57, 57 = normal capacity), FMA-UE Upper Extremity motor section of the Fugl-Meyer Assessment (score = 0–66, 66 = normal function), SD standard deviation, T₀ stroke onset

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