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Table 3 Results sample size calculation: stratification based on presence or absence of voluntary finger extension

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

 

All patients (N = 114)

Voluntary Finger Extension (N = 57)

No Voluntary Finger Extension (N = 57)

Time interval

Group 1 Mean ± SD

Group 0 Mean ± SD

SD pooled

Variance

Sample size

Group 1 Mean ± SD

Group 0 Mean ± SD

SD pooled

Variance

Sample size

Group 1 Mean ± SD

Group 0 Mean ± SD

SD pooled

Variance

Sample size

FMA-UE

 T0 to 1 week

23.17 ± 20.80

19.73 ± 18.36

19.61

385

308

39.31 ± 16.59

33.68 ± 15.74

16.17

262

211

7.03 ± 8.11

5.79 ± 5.92

7.10

50

44

 T0 to 3 weeks

29.22 ± 23.10

26.21 ± 20.61

21.89

476

385

45.55 ± 15.19

42.50 ± 15.62

15.40

237

191

9.62 ± 9.62

7.86 ± 7.84

8.77

77

64

 T0 to 5 weeks

32.05 ± 23.61

30.57 ± 21.73

22.69

515

411

50.24 ± 14.88

48.46 ± 11.85

13.45

181

147

9.97 ± 11.32

13.21 ± 13.39

12.40

154

125

 T0 to 8 weeks

30.83 ± 24.00

33.36 ± 22.76

23.39

547

438

49.41 ± 13.80

49.75 ± 12.90

13.36

178

145

12.38 ± 12.98

11.64 ± 13.79

13.39

179

145

 T0 to 12 weeks

34.33 ± 25.09

31.09 ± 22.44

23.80

567

453

51.03 ± 14.22

51.29 ± 12.14

13.22

175

143

16.24 ± 17.04

16.04 ± 16.15

16.60

276

222

ARAT

 T0 to 1 week

10.91 ± 13.98

9.91 ± 14.39

14.19

201

218

20.62 ± 14.06

19.21 ± 15.48

14.79

219

235

1.21 ± 2.29

0.61 ± 1.69

2.01

4

9

 T0 to 3 weeks

16.16 ± 17.60

14.98 ± 17.14

17.37

302

323

29.07 ± 16.06

27.54 ± 15.62

15.84

251

271

2.48 ± 6.10

0.82 ± 1.98

4.54

21

24

 T0 to 5 weeks

18.76 ± 19.72

18.21 ± 19.08

19.40

376

403

34.35 ± 16.45

28.36 ± 15.13

15.80

250

268

2.55 ± 6.75

3.61 ± 7.89

7.34

54

62

 T0 to 8 weeks

22.22 ± 20.85

17.20 ± 19.01

19.95

398

425

34.93 ± 16.57

32.00 ± 15.18

15.89

253

271

5.07 ± 10.48

3.71 ± 6.77

8.82

78

86

 T0 to 12 weeks

22.33 ± 22.04

21.48 ± 19.80

20.95

439

471

38.17 ± 13.31

35.79 ± 14.12

13.72

188

205

4.03 ± 9.14

5.61 ± 12.39

10.89

119

130

  1. 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, T 0 stroke onset
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