Table 2.
Changes of primary and secondary outcomes in matched cohorts.
| Mean (SD) |
Effect size (Cohen's d) | Mean (95% CI) | P value | ||
|---|---|---|---|---|---|
| Surgery | Rehabilitation | Adjusted Mean difference | |||
| Number of patients | 168 | 168 | |||
| Primary outcome | |||||
| Change in UEFM score from baseline to 2-year follow-up | |||||
| Total | 15.14 (4.78) | 2.35 (1.79) | 3.55(3.20∼3.89) | 12.79 (12.02, 13.56) | < 0.0001 |
| CONCENT-eligible a | 18.00 (4.86) | 2.08 (1.26) | 4.23(2.90∼5.53) | 16.35 (13.79, 18.91) | < 0.0001 |
| CONCENT-ineligible b | 14.82 (4.67) | 2.37 (1.82) | 3.52(3.17∼3.88) | 12.44 (11.65, 13.24) | < 0.0001 |
| Secondary outcomes | |||||
| Changes in MAS score from baseline to 2-year follow-up c | |||||
| Elbow | |||||
| Total | -0.88 (0.58) | -0.13 (0.55) | -0.88(-1.11∼-0.66) | -0.76 (- 0.87, -0.64) | < 0.0001 |
| CONCENT-eligible | -0.94 (0.66) | -0.08 (0.28) | -1.89(-2.76∼-1.01) | -0.92 (-1.33, -0.51) | 0.00016 |
| CONCENT-ineligible | -0.87 (0.57) | -0.14 (0.57) | -0.82(-1.06∼-0.59) | -0.74 (-0.87, -0.61) | < 0.0001 |
| Forearm rotation | |||||
| Total | -0.97 (0.73) | -0.20 (0.53) | -0.91(-1.14∼-0.69) | -0.78 (-0.91, -0.64) | < 0.0001 |
| CONCENT-eligible | -1.12 (0.78) | -0.23 (0.44) | -1.21(-1.99∼-0.41) | -0.90 (-1.37, -0.43) | 0.00078 |
| CONCENT-ineligible | -0.95 (0.72) | -0.20 (0.54) | -0.88(-1.12∼-0.65) | -0.76 (-0.90, -0.62) | < 0.0001 |
| Wrist | |||||
| Total | -1.10 (0.72) | -0.18 (0.63) | -1.03(-1.25∼-0.80) | -0.93 (-1.07, -0.79) | < 0.0001 |
| CONCENT-eligible | -1.53 (0.80) | -0.15 (0.38) | -1.47(-2.28∼-0.64) | -1.11 (-1.55, -0.67) | < 0.0001 |
| CONCENT-ineligible | -1.05 (0.70) | -0.19 (0.65) | -1(-1.24∼-0.76) | -0.89 (- 1.03, -0.74) | <0.0001 |
| Thumb | |||||
| Total | -1.37 (0.62) | -0.23 (0.51) | -1.17(-1.40∼-0.94) | -1.14 (-1.25, -1.02) | <0.0001 |
| CONCENT-eligible | -1.59 (0.62) | -0.62 (0.77) | -0.12(-0.84∼0.61) | -0.68 (-1.23, -0.14) | 0.021 |
| CONCENT-ineligible | -1.34 (0.62) | -0.19 (0.47) | -1.28(-1.52∼-1.03) | -1.16 (-1.27, -1.04) | < 0.0001 |
| Fingers 2–5 | |||||
| Total | -1.04 (0.75) | -0.17 (0.59) | -0.96(-1.19∼-0.74) | -0.88 (-1.02, -0.75) | < 0.0001 |
| CONCENT-eligible | -1.12 (0.49) | -0.31 (0.85) | -1.37(-2.17∼-0.56) | -0.84 (-1.20, -0.48) | < 0.0001 |
| CONCENT-ineligible | -1.03 (0.77) | -0.16 (0.56) | -0.94(-1.17∼-0.70) | -0.88 (-1.03, -0.74) | <0.0001 |
| Changes in ROM from baseline to 2-year follow-up d | |||||
| Elbow | |||||
| Total | 30.54 (14.88) | -4.03 (6.14) | 1.05(0.82∼1.28) | 35.11 (32.77, 37.45) | < 0.0001 |
| CONCENT-eligible | 35.00 (15.31) | -3.08 (6.30) | 1.73(0.87∼2.57) | 39.16 (30.80, 47.52) | < 0.0001 |
| CONCENT-ineligible | 30.03 (14.79) | -4.11 (6.14) | 1.01(0.77∼1.24) | 34.66 (32.23, 37.08) | < 0.0001 |
| Forearm rotation | |||||
| Total | 38.21 (15.94) | -2.26 (3.59) | 1.70(1.45∼1.95) | 41.14 (38.76, 43.53) | < 0.0001 |
| CONCENT-eligible | 39.12 (15.64) | -1.54 (3.15) | 2.21(1.27∼3.12) | 40.49 (32.01, 48.97) | < 0.0001 |
| CONCENT-ineligible | 38.11 (16.02) | -2.32 (3.63) | 1.67(1.41∼1.93) | 41.17 (38.68, 43.67) | <0.0001 |
| Wrist | |||||
| Total | 38.54 (16.13) | -2.08 (3.97) | 1.45(1.21∼1.69) | 41.05 (38.61, 43.49) | < 0.0001 |
| CONCENT-eligible | 45.00 (15.61) | -2.31 (4.39) | 1.60(0.75∼2.42) | 44.88 (36.45, 53.31) | < 0.0001 |
| CONCENT-ineligible | 37.81 (16.08) | -2.06 (3.95) | 1.44(1.19∼1.69) | 40.40 (37.85, 42.95) | < 0.0001 |
a
CONCENT-eligible denotes the patients who were eligible according the previous RCT criteria in this study.
b
CONCENT-ineligible refers to the patients who were not eligible according the previous RCT criteria in this study.
c
MAS refers to the Modified Ashworth Scale, a measure of spasticity (muscle tone) in the paralyzed arm; Scores range from 0 to 5 at each of five joints, with higher scores indicating more severe spasticity. Negative numbers indicate decrease and positive numbers indicate increase in spasticity from baseline to 2-year follow-up.
d
ROM refers to the Range of motion of the paralyzed arm