Table 4.
Analysis of secondary endpoints in the ITT population.
| N |
Mean change P1-BL |
Difference in change between groups [95% CI] | p value | |||
|---|---|---|---|---|---|---|
| Int. | Ctrl. | Int. | Ctrl. | |||
| UEFMA passive joint motion/pain | 57 | 61 | −0.32 | −0.25 | −0.00 [−0.80; 0.79] | 0.990 |
| Action Research Arm Test | 57 | 61 | 9.81 | 12.08 | −1.67 [−5.17; 1.83] | 0.347 |
| Nine hole peg test–non affected hand (Test) | 58 | 61 | 0.03 | 0.01 | 0.01 [−0.02; 0.03] | 0.494 |
| Nine hole peg test–non affected hand (Mean of training & test) | 58 | 61 | 0.02 | 0.02 | −0.01 [−0.03; 0.02] | 0.556 |
| Nine hole peg test–affected hand (Test) | 58 | 61 | 0.07 | 0.08 | −0.01 [−0.04; 0.02] | 0.608 |
| Nine hole peg test–affected hand (Mean of training & test) | 58 | 61 | 0.07 | 0.07 | −0.00 [−0.03; 0.03] | 0.762 |
| Box and block test | 57 | 60 | 10.32 | 10.75 | −0.70 [−4.10; 2.71] | 0.686 |
| Muscle strength, affected side (MRC) | 58 | 61 | 0.42 | 0.45 | −0.02 [−0.20; 0.16] | 0.850 |
| Grip pinch force–whole hand power grip | 58 | 61 | 0.08 | 0.10 | −0.03 [−0.08; 0.03] | 0.374 |
| Grip pinch force–pincer grasp | 57 | 60 | 0.15 | 0.18 | −0.02 [−0.10; 0.07] | 0.669 |
| Grip pinch force–key grip | 58 | 61 | 0.12 | 0.13 | −0.00 [−0.08; 0.07] | 0.924 |
| Grip pinch force–thumb opposition | 56 | 58 | 0.09 | 0.11 | −0.01 [−0.09; 0.07] | 0.851 |
| Frey somatosensory (non-affected hand) | 54 | 58 | −0.07 | 0.17 | −0.18 [−0.40; 0.04] | 0.107 |
| Frey somatosensory (affected hand) | 51 | 55 | 0.30 | 0.34 | −0.09 [−0.35; 0.18] | 0.524 |
| Ashworth spasticity scale, affected side | 58 | 61 | 0.00 | −0.02 | 0.03 [−0.05; 0.10] | 0.487 |
| Stroke impact scale strength | 56 | 59 | 11.50 | 11.33 | −0.21 [−5.58; 5.17] | 0.940 |
| Stroke impact scale memory | 56 | 59 | 5.93 | 4.11 | −1.60 [−5.08; 1.89] | 0.367 |
| Stroke impact scale emotion | 56 | 59 | 1.64 | 6.21 | −3.88 [−8.61; 0.86] | 0.107 |
| Stroke impact scale communication | 56 | 58 | 2.17 | 3.61 | −3.65 [−6.97; −0.33] | 0.031 |
| Stroke impact scale activities of daily living | 56 | 58 | 14.44 | 12.79 | −0.14 [−5.31; 5.03] | 0.958 |
| Stroke impact scale mobility | 55 | 59 | 16.48 | 15.64 | −0.11 [−6.45; 6.24] | 0.974 |
| Stroke impact scale hand function | 53 | 59 | 17.95 | 25.73 | −7.79 [−16.27; 0.69] | 0.071 |
| Stroke impact scale social participation | 50 | 55 | 7.46 | 3.09 | −1.89 [−11.22; 7.45] | 0.689 |
| Stroke impact scale physical domain | 53 | 58 | 15.19 | 16.14 | −1.63 [−6.52; 3.26] | 0.511 |
| Stroke impact scale stroke recovery | 53 | 59 | 13.81 | 16.07 | −1.56 [−7.39; 4.28] | 0.598 |
| Patient Health Questionnaire 9 | 54 | 58 | −1.35 | −1.83 | 1.14 [−0.13; 2.40] | 0.077 |
| NIHSS | 58 | 61 | −0.93 | −1.16 | 0.31 [−0.30; 0.92] | 0.316 |
| Barthel Index | 58 | 60 | 12.84 | 11.75 | −1.01 [−6.93; 4.90] | 0.735 |
Mean change from baseline to P1 shown unadjusted (as mean ± SD) and adjusted (as mean with [95% CI]) as well as the adjusted difference in change between groups (difference with [95% CI]). Adjusted means and mean difference resulting from an ANCOVA model adjusted for the respective baseline measurement, type of stroke (cortical, subcortical), age and time between stroke and baseline examination. All values shown are based on data imputed by the LOCF approach.
Int. = intervention group; Ctrl. = control group; UEFMA = Upper-Extremity-Fugl-Meyer-Assessment; NIHSS = National Institutes of Health Stroke Scale.