Table 4.
The Impact of OnabotulinumtoxinA Treatment for Spasticity on Disability Assessment Scale (DAS) Scores in the Lower Limb Population *
| Tx1 (N=529) † | Tx2 (N=465) | Tx3 (N=394) | Tx4 (N=336) | Tx5 (N=257) | Tx6 (N=184) | Tx7 (N=128) | Tx8 (N=39) | |
|---|---|---|---|---|---|---|---|---|
| Dressing, N (%) | ||||||||
| 0 ‐ No disability | 90 (17.0) | 92 (19.8) | 70 (17.8) | 64 (19.0) | 53 (20.6) | 46 (25.0) | 28 (21.9) | 7 (17.9) |
| 1 ‐ Mild disability | 172 (32.5) | 173 (37.2) | 158 (40.1) | 136 (40.5) | 103 (40.1) | 83 (45.1) | 52 (40.6) | 17 (43.6) |
| 2 ‐ Moderate disability | 187 (35.3) | 143 (30.8) | 126 (32.0) | 106 (31.5) | 70 (27.2) | 34 (18.5) | 34 (26.6) | 15 (38.5) |
| 3 ‐ Severe disability | 80 (15.1) | 57 (12.3) | 40 (10.2) | 30 ( 8.9) | 31 (12.1) | 21 (11.4) | 14 (10.9) | 0 ( 0.0) |
| OR (95% CI) | 1.7 (1.3, 2.3) | 1.8 (1.3, 2.4) | 2.0 (1.5, 2.8) | 1.9 (1.3, 2.7) | 2.5 (1.7, 3.8) | 2.0 (1.3, 3.2) | 2.9 (1.3, 6.1) | |
| F‐Value: 4.7; P < .0001 ‡ | ||||||||
| Hygiene, N (%) | ||||||||
| 0 ‐ No disability | 183 (34.6) | 173 (37.2) | 134 (34.0) | 126 (37.5) | 91 (35.4) | 75 (40.8) | 48 (37.5) | 11 (28.2) |
| 1 ‐ Mild disability | 139 (26.3) | 130 (28.0) | 135 (34.3) | 105 (31.3) | 79 (30.7) | 58 (31.5) | 41 (32.0) | 13 (33.3) |
| 2 ‐ Moderate disability | 142 (26.8) | 115 (24.7) | 90 (22.8) | 79 (23.5) | 59 (23.0) | 31 (16.8) | 27 (21.1) | 15 (38.5) |
| 3 ‐ Severe disability | 65 (12.3) | 47 (10.1) | 35 ( 8.9) | 26 ( 7.7) | 28 (10.9) | 20 (10.9) | 12 ( 9.4) | 0 ( 0.0) |
| OR (95% CI) | 1.4 (1.0, 1.8) | 1.3 (1.0, 1.8) | 1.5 (1.1, 2.0) | 1.0 (0.7, 1.5) | 1.3 (0.9, 2.0) | 1.3 (0.8, 2.2) | 1.5 (0.7, 3.1) | |
| F‐Value: 1.3; P = .2258 | ||||||||
| Limb Posture, N (%) | ||||||||
| 0 ‐ No disability | 54 (10.2) | 55 (11.8) | 53 (13.5) | 45 (13.4) | 36 (14.0) | 29 (15.8) | 20 (15.6) | 4 (10.3) |
| 1 ‐ Mild disability | 128 (24.2) | 150 (32.3) | 152 (38.6) | 126 (37.5) | 97 (37.7) | 79 (42.9) | 46 (35.9) | 19 (48.7) |
| 2 ‐ Moderate disability | 242 (45.7) | 202 (43.4) | 146 (37.1) | 125 (37.2) | 95 (37.0) | 57 (31.0) | 46 (35.9) | 13 (33.3) |
| 3 ‐ Severe disability | 105 (19.8) | 58 (12.5) | 43 (10.9) | 40 (11.9) | 29 (11.3) | 19 (10.3) | 16 (12.5) | 3 ( 7.7) |
| OR (95% CI) | 2.1 (1.6, 2.8) | 3.1 (2.3, 4.2) | 3.0 (2.2, 4.1) | 3.0 (2.1, 4.2) | 3.1 (2.1, 4.6) | 2.5 (1.6, 3.9) | 3.0 (1.4, 6.3) | |
| F‐Value: 11.5; P < .0001 | ||||||||
| Mobility, N (%) | ||||||||
| 0 ‐ No disability | 27 ( 5.1) | 22 ( 4.7) | 20 ( 5.1) | 15 ( 4.5) | 15 ( 5.8) | 8 ( 4.3) | 5 ( 3.9) | 0 ( 0.0) |
| 1 ‐ Mild disability | 67 (12.7) | 102 (21.9) | 97 (24.6) | 94 (28.0) | 67 (26.1) | 59 (32.1) | 35 (27.3) | 12 (30.8) |
| 2 ‐ Moderate disability | 262 (49.5) | 235 (50.5) | 191 (48.5) | 161 (47.9) | 129 (50.2) | 86 (46.7) | 58 (45.3) | 21 (53.8) |
| 3 ‐ Severe disability | 173 (32.7) | 106 (22.8) | 86 (21.8) | 66 (19.6) | 46 (17.9) | 31 (16.8) | 30 (23.4) | 6 (15.4) |
| OR (95% CI) | 2.5 (1.9, 3.4) | 2.9 (2.1, 4.0) | 3.5 (2.5, 5.0) | 4.0 (2.8, 5.8) | 3.3 (2.2, 5.0) | 2.5 (1.6, 4.1) | 3.1 (1.4, 6.7) | |
| F‐Value: 11.6; P < .0001 | ||||||||
| Pain, N (%) | ||||||||
| 0 ‐ No disability | 188 (35.5) | 196 (42.2) | 182 (46.2) | 139 (41.4) | 113 (44.0) | 88 (47.8) | 55 (43.3) | 18 (46.2) |
| 1 ‐ Mild disability | 138 (26.1) | 135 (29.0) | 108 (27.4) | 112 (33.3) | 75 (29.2) | 48 (26.1) | 34 (26.8) | 11 (28.2) |
| 2 ‐ Moderate disability | 134 (25.3) | 94 (20.2) | 78 (19.8) | 61 (18.2) | 52 (20.2) | 33 (17.9) | 26 (20.5) | 8 (20.5) |
| 3 ‐ Severe disability | 69 (13.0) | 40 ( 8.6) | 26 ( 6.6) | 24 ( 7.1) | 17 ( 6.6) | 15 ( 8.2) | 12 ( 9.4) | 2 ( 5.1) |
| OR (95% CI) | 2.0 (1.5, 2.6) | 2.6 (1.9, 3.5) | 2.2 (1.6, 3.0) | 2.2 (1.6, 3.2) | 2.4 (1.6, 3.7) | 1.8 (1.1, 2.8) | 2.9 (1.3, 6.3) | |
| F‐Value: 6.8; P < .0001 | ||||||||
CI = confidence interval; N = number of patients; OR = odds ratio; Tx = treatment session.
The DAS was developed to objectively measure functional impairment resulting from spasticity across 5 subscales, including dressing, hygiene, limb posture, mobility, and pain. 48 For each subscale, patients were evaluated on a 4‐point scale (range: 0‐3), where “0” represents no disability and “3” represents severe disability (normal activities limited). DAS was assessed by the clinician at treatment session 1 (prior to onabotulinumtoxinA administration) and at each subsequent treatment session.
For statistical analysis, data from treatment session 1 were used as a reference.
To account for repeated measures (ie, each individual at the start of each treatment session), data were analyzed using a general linear mixed model (mixed ordinal logistic regression). The outcome consisted of ordinal categories; therefore, a multinomial distribution was used to perform ordinal logistic regression. For each subscale, the F value and level of significance (P value) are shown.