Table 1.
Baseline clinical characteristics of the efficacy population
| Parameter | Values (%) | Range | n/missing or untestable |
|---|---|---|---|
| Distribution of spasticity (MAS ≥2), n (%) | |||
| Shoulder | 235 (55.7) | 422/34 | |
| Elbow | 335 (75.1) | 446/10 | |
| Wrist | 344 (77.8) | 442/14 | |
| Fingers | 368 (82.9) | 444/12 | |
| Thumb | 292 (66.8) | 437/19 | |
| Soft tissue shortening (limiting ≥half range), n (%) | 456/0 | ||
| Shoulder | 156 (34.2) | ||
| Elbow | 150 (32.9) | ||
| Wrist | 179 (39.3) | ||
| Hand | 206 (45.2) | ||
| Motor paralysis (no useful function), n (%) | 456 | ||
| Proximal | 95 (20.8) | ||
| Distal | 260 (57.0) | ||
| Sensory, n (%) | 447/9 | ||
| Partial | 208 (45.6) | ||
| Complete | 20 (4.4) | ||
| Cognitive/communicative impairment, n (%) | |||
| Cognitive | 98 (21.5) | 455/1 | |
| Speech and language | 159 (34.9) | 446/10 | |
| Neglect, dyspraxia or visuo-perceptual difficulties | 60 (13.2) | 456/0 | |
| Other symptoms, which may impact on functional outcome, n (%) | 456/0 | ||
| Emotional/behavioural impairment | 149 (32.7) | ||
| Pain* | 78 (17.1) | ||
| Fatigue | 48 (10.5) | ||
| Impairment scores (modified NIS) † | Median (Q1–Q3) | Range | n/untestable |
| Proximal upper limb motor score (arm raising/reaching) | 2 (1–2) | 0–3 | 456/0 |
| Distal upper limb motor score (hand function) | 3 (2–3) | 0–3 | 456/0 |
| Sensation | 1 (0–2) | 0–3 | 447/9 |
| Communication impairment | 0 (0–1) | 0–3 | 455/1 |
| Cognitive impairment | 0 (0–0) | 0–3 | 446/10 |
| Spasticity (MAS)‡ | n/missing | ||
| Distal composite MAS score | 7.0 (6–9) | 0–12 | 431/25 |
| Proximal composite MAS score | 4.0 (3–5) | 0–8 | 422/34 |
| Baseline outcome measures | |||
| Total MAS score, mean (SD) | 11.0 (3.3) | 1–20 | 414/42 |
| GAS weighted score, mean (SD) | 36.4 (7.7) | 21.2–43.8 | 456/0 |
As multiple answers were possible, the sum of some percentages in this table may exceed 100%.
*Data extracted from injected segments at baseline, when at least one muscle of the segment was injected.
†Modified NIS: the score range for each of the five domains is 0=none; 1=mild impairment affecting high-level function only; 2=significant impairment; 3=severe impairment, effectively preventing function. Further details are available from the corresponding author.
‡MAS composite scores: proximal MAS score=shoulder+elbow scores; MAS-distal=wrist+fingers+thumb scores; MAS-total=composite sum of all five joints (total composite scores were only calculated if individual MAS scores were recorded at all five joints).
MAS, Modified Ashworth Scale; NIS, Neurological Impairment Scale.