Table 3. Results of the Secondary Outcome Measures by Time Point and Groupa.
| Outcome | EAW group | SOC group | P value |
|---|---|---|---|
| Global impression of severity of SCI | |||
| Participant’s impression | |||
| Baseline score, median (IQR) | 2 (2 to 3) (n = 78) | 2 (2 to 3) (n = 82) | .74 |
| Training and orientation | 2 (1 to 3) (n = 54) | 3 (2 to 3) (n = 67) | .01 |
| 2 Months (intervention) | 2 (2 to 3) (n = 47) | 3 (2 to 3) (n = 59) | .15 |
| 4 Months (intervention) | 2 (1.5 to 3) (n = 44) | 3 (2 to 4) (n = 57) | .07 |
| Change from baseline score | |||
| Training and orientation | 0 (−1 to 0) (n = 54) | 0 (0 to 1) (n = 66) | .01 |
| 2 Months (intervention) | 0 (−1 to 1) (n = 47) | 0 (0 to 1) (n = 58) | .25 |
| 4 Months (intervention) | 0 (−0.5 to 0) (n = 44) | 0 (0 to 1) (n = 56) | .06 |
| Companion’s impression | |||
| Baseline score, median (IQR) | 2 (2 to 3) (n = 77) | 2 (2 to 3) (n = 81) | .93 |
| Training and orientation | 2 (2 to 3) (n = 51) | 2 (1 to 3) (n = 64) | .34 |
| 2 Months (intervention) | 2 (2 to 3) (n = 45) | 2 (2 to 3) (n = 56) | .63 |
| 4 Months (intervention) | 2 (1 to 3) [41] | 2 (2 to 4) [51] | .92 |
| Change from baseline score | |||
| Training and orientation | 0 (−1 to 1) (n = 51) | 0 (−1 to 1) (n = 63) | .99 |
| 2 Months (intervention) | 0 (−1 to 1) (n = 45) | 0 (−1 to 1 (n = 56) | .92 |
| 4 Months (intervention) | 0 (0 to 1) (n = 41) | 0 (0 to 1) (n = 51) | .89 |
| Global impression of improvement of SCI | |||
| Participant’s change from baseline score, median (IQR) | |||
| Training and orientation | 5 (3 to 6) (n = 54) | 2 (1 to 3) (n = 69) | <.001b |
| 2 Months (intervention phase) | 4 (3 to 6) (n = 47) | 2 (1 to 5) (n = 58) | <.001b |
| 4 Months (postrandomization) | 5 (3 to 6) (n = 43) | 3 (2 to 4) (n = 55) | <.001b |
| Companion’s change from baseline score, median (IQR) | |||
| Training and orientation | 5 (3 to 6) (n = 51) | 2.5 (1 to 4.5) (n = 64) | <.001b |
| 2 Months (intervention) | 5 (3 to 6) (n = 45) | 3 (2 to 4) (n = 55) | <.001b |
| 4 Months (intervention) | 5 (4 to 6) (n = 40) | 3 (1 to 5) (51) | .01b |
| PROMIS sleep disturbance | |||
| Baseline T score, median (IQR) | 46 (38 to 53) (n = 78) | 46 (38 to 54) (83) | .83 |
| Training and orientation | 44 (38 to 54) (n = 54) | 50 (41 to 55) (68) | .20 |
| 2 Months (intervention) | 46 (38 to 55) (n = 48) | 49 (40 to 54) (59) | .92 |
| 4 Months (intervention) | 47 (40 to 58) (n = 45) | 48 (41 to 56) (57) | .94 |
| Change from baseline T score, median (IQR) | |||
| Training and orientation | −1.9 (−5.7 to 3.0) (n = 54) | 1.3 (−3.2 to 7.0) (68) | .01 |
| 2 Months (intervention) | −2.7 (−7.0 to 2.2) (n = 48) | 1.8 (−3.2 to 5.7) (59) | .01 |
| 4 Months (intervention) | 0.0 (−4.8 to 4.0) (n = 45) | 1.5 (−4.1 to 5.3) (57) | .50 |
| SCI-FI | |||
| Baseline summary T score, mean (SD) | 344 (24.50) (n = 29) | 343 (20.6) (n = 31) | .92 |
| Training and orientation | 345 (23.72) (n = 20) | 338 (17.6) (n = 24) | .24 |
| 2 Months (intervention) | 348 (24.92) (n = 18) | 335 (20.6) (n = 24) | .09 |
| 4 Months (intervention) | 348 (16.53) (n = 22) | 339 (24.0) (n = 22) | .17 |
| Change from baseline T score, mean (SD) | |||
| Training and orientation | 5.4 (20.97) (n = 18) | −5.8 (11.63) (n = 19) | .06 |
| 2 Months (intervention) | 7.3 (16.00) (n = 16) | −4.5 (12.99) (n = 19) | .02 |
| 4 Months (intervention) | 3.8 (16.36) (n = 17) | −8.6 (20.60) (n = 17) | .06 |
| Emotional health | |||
| Negative constraints | |||
| Baseline summary T score, median (IQR) | 219 (200 to 255) (n = 78) | 226 (201 to 257) (83) | .60 |
| Training and orientation | 220 (199 to 245) (n = 54) | 226 (195 to 272) (68) | .28 |
| 2 Months (intervention) | 208 (194 to 233) (n = 48) | 219 (188 to 273) (60) | .35 |
| 4 Months (intervention) | 207 (191 to 226) (n = 44) | 223 (193 to 263) (57) | .10 |
| Change from baseline summary T score, median (IQR) | |||
| Training and orientation | −5.3 (−19.0 to 7.1) (n = 54) | 1.1 (−10.3 to 14.2) (n = 68) | .06 |
| 2 mo (intervention) | −6.4 (−21.3 to 6.5) (n = 48) | −0.7 (−10.6 to 14.0) (n = 60) | .08 |
| 4 mo (intervention) | −8.7 (−21.3 to 4.0) (n = 44) | −3.0 (−13.0 to 10.6) (n = 57) | .06 |
| Positive aspects | |||
| Baseline score, median (IQR) | 173 (159 to 189) (n = 78) | 167 (150 to 192) (n = 82) | .70 |
| Training and orientation | 173 (155 to 187) (n = 54) | 160 (144 to 199) (n = 68) | .70 |
| 2 Months (intervention) | 178 (154 to 192) (n = 48) | 165 (141 to 191) (n = 60) | .30 |
| 4 Months (intervention) | 176 (160 to 192) (n = 45) | 162 (141 to 189) (n = 57) | .19 |
| Change from baseline score, median (IQR) | |||
| Training and orientation | 0.0 (−7.9 to 7.6) (n = 54) | 0.0 (−11.3 to 5.9) (n = 67) | .50 |
| 2 Months (intervention) | 0.2 (−2.9 to 11.6) (n = 48) | 0.0 (−10.6 to 6.7) (n = 59) | .21 |
| 4 Months (intervention) | 2.4 (−2.7 to 12.7) (n = 45) | 0.0 (−10.0 to 7.1) (n = 56) | .12 |
| Social participation | |||
| Baseline summary T score, median (IQR) | 155 (141 to 169) (n = 77) | 155 (143 to 178) (n = 83) | .33 |
| Training and orientation | 154 (145 to 169) (n = 53) | 153 (141 to 177) (n = 68) | .87 |
| 2 Months (intervention) | 149 (142 to 173) (n = 47) | 155 (137 to 179) (n = 59) | .98 |
| 4 Months (intervention) | 158 (145 to 178) (n = 44) | 152 (139 to 176) (n = 57) | .37 |
| Change from baseline summary T score, median (IQR) | |||
| Training and orientation | 2.4 (−7.8 to 10.5) (n = 52) | 0.0 (−8.3 to 4.8) (n = 68) | .12 |
| 2 Months (intervention) | 0.0 (−7.5 to 9.5) (n = 46) | −0.2 (−7.7 to 4.4) (n = 59) | .23 |
| 4 Months (intervention) | 4.8 (−4.3 to 14.5) (n = 43) | 0.0 (−13.4 to 6.3) (n = 57) | .04 |
Abbreviations: EAW, exoskeletal-assisted walking; PROMIS, Patient-Reported Outcomes Measurement Information System (short form); SCI, spinal cord injury; SCI-FI, Spinal Cord Injury–Functional Index; SOC, stand of care.
a
Continuous data with normal distribution are presented as mean (SD) using unpaired, 2-tailed t tests, and nonnormally distributed data are presented as median (IQR) using Wilcoxon tests.
b
Significant results (P ≤ .001) are in favor of the EAW group. Any other nonsignificant results (P ≤ .01) are in favor of the EAW group at those time points.