Table 2.
Primary and motor secondary outcomes
Ziclague® | Placebo | 95% CI | SE | p-values | |||
---|---|---|---|---|---|---|---|
Pre | Post | Pre | Post | ||||
Outcomes | N = 52 | N = 52 | N = 52 | N = 52 | |||
Primary outcome • | |||||||
Self-selected gait velocity (m/s) | 0.85 (±0.31) | 0.86 (±0.34) | 0.81 (±0.31) | 0.86 (±0.31) | [-0.07, 0.01] | 0.02 | 0.17 |
Secondary outcomes • | |||||||
Maximal gait velocity (m/s) | 1.17 (±0.44) | 1.17 (±0.45) | 1.11 (±0.46) | 1.17 (±0.46) | [-0.09, -0.01] | 0.02 | 0.04 |
Endurance walking by 6MWT (m) | 250.0 (±94.6) | 249.3 (±103.4) | 244.6 (±96.3) | 249.6 (±95.1) | [-14.70, 4.90] | 5.0 | 0.32 |
Spasticity (MAS) | |||||||
Hip adductors muscles | 1.69 (±0.79) | 1.54 (±0.68) | 1.74 (±0.85) | 1.61 (±0.72) | [-0.58, 1.02] | 0.41 | 0.59 |
Triceps surae muscles | 1.88 (±0.77) | 1.86 (±0.79) | 1.85 (±0.87) | 1.73 (±0.82) | [-0.56, 1.04] | 0.41 | 0.56 |
Muscle strength (MRC) | |||||||
Hip adductors muscles | 4.60 (±0.66) | 4.58 (±0.79) | 4.50 (±0.82) | 4.58 (±0.70) | NA | 1.20 | 0.41 |
Triceps surae muscles | 4.48 (±0.93) | 4.54 (±0.79) | 4.50 (±0.82) | 4.56 (±0.82) | [-0.51, 2.19] | 0.69 | 0.23 |
Primary and motor secondary outcomes: mean values (±standard deviation), 95% CI, standard error and p-values, obtained by GEE models. Considered on patients who completed at least two visits of the clinical trial (N = 52). 6MWT, 6-minute walking test; CI, confidence interval; MAS, modified Ashworth scale; MRC, Medical Research Council scale; NA, not applicable; SE, standard error