| |
Botulinum toxin A
|
Placebo
|
Patients | (n) | 22 | 18 |
Age at recruitment | Median (range) | 5.5 (2.8–13.9) | 6.2 (3.4–16.4) |
Gender ratio | (F:M) | 12:10 | 5:13 |
Type of cerebral palsy (n) | | | |
Hemiplegic | | 9 | 3 |
Diplegic | | 13 | 15 |
Initial foot contact | (n = legs) | 34 | 33 |
Heel strike | (n) | 0 | 0 |
Flat foot strike | (n) | 1 | 1 |
Toe–heel strike | (n) | 3 | 2 |
Mild toe strike | (n) | 18 | 15 |
Marked toe strike | (n) | 12 | 15 |
GMFM (%) | (n = patients) | 21 | 15 |
Lying and rolling | Median (IQR) | 100 (96.1–100) | 98.0 (96.1–100) |
Sitting | Median (IQR) | 100 (98.3–100) | 98.3 (96.7–98.3) |
Crawling and kneeling | Median (IQR) | 97.6 (90.5–100) | 92.9 (78.6–97.6) |
Standing | Median (IQR) | 85.9 (60.0–96.8) | 71.8 (23.1–79.5) |
Walking and running | Median (IQR) | 69.4 (26.4 -86.5) | 54.2 (18.1–79.2) |
Total | Median (IQR) | 89.0 (74.5–96.3) | 84.0 (62.0–90.0) |
Physiological cost index | Median (IQR) | 0.7 (0.5, 1.2) | 0.8 (0.6, 1.4) |
Passive ankle dorsiflexion | n | 20 | 16 |
Knee extended | Mean (SD) | 73.3 (11.4) | 71.5 (11.9) |
Dose of trial drug (U/kg) | | | |
Diplegic | mean (SD) | 24.8 (3.2) | 24.2 (5.4) |
Hemiplegic | mean (SD) | 16.4 (4.0) | 14.4 (1.6) |
Muscles injected | | | |
Gastrocnemius only | n (%) | 0 | 5 (15.1%) |
Gastrocnemius + soleus | n (%) | 34 (97.1%) | 26 (78.8%) |
Gastrocnemius + hamstrings | n (%) | 1 (2.9%) | 0 |
Gastrocnemius + soleus + hamstrings | n (%) | 0 | 2 (6.1%) |