Table 5.
Number and percent of participants by walking velocity categories.
| Outcomes | Velocity and distance categories | 12 sessions n (%) | 24 sessions n (%) | 36 sessions n (%) | |
|---|---|---|---|---|---|
| 10MWT | Primary | ≥0.17 m/s | 46 (92%) | ||
| Primary | ≥0.25 m/s | 31 (62%) | 41 (82%) | ||
| Slow: <0.25 m/s | 21 (42%) | 16 (32%) | 10 (20%) | ||
| Medium: ≥0.25 to <0.40 m/s | 16 (32%) | 18 (36%) | 22 (44%) | ||
| Fast: ≥0.40 m/s | 13 (26%) | 16 (32%) | 17 (34%) | ||
| ReWalk (only) users who met FDA velocity and distance criteria (10MWT: ≥ 0.40 m/s and 6MWT: ≥110 m) | Total (n = 28) | 9 (32%) | 15 (54%) | 15 (54%) | |
| Com Tetra (n = 0) | n/a | n/a | n/a | ||
| Inc Tetra (n = 1) | 1 (100%) | 1 (100%) | 1 (100%) | ||
| Com Para (n = 20) | 6 (30%) | 11 (55%) | 11 (55%) | ||
| Inc Para (n = 7) | 2 (29%) | 3 (43%) | 3 (43%) | ||
| 6MWT | Primary | ≥50 m | 48 (96%) | ||
| Primary | ≥80 m | 35 (70%) | 41 (82%) | ||
| Slow: <80 m | 16 (32%) | 14 (28%) | 8 (16%) | ||
| Medium: ≥80 to <110 m | 18 (36%) | 12 (24%) | 8 (16%) | ||
| Fast: ≥110 m | 16 (32%) | 24 (48%) | 33 (66%) | ||
| FIM ≥4 | 26 (52%) | 37 (74%) | 45 (90%) | ||
| TUG | Primary | ≤ 120 s | 48 (96%) | ||
| Primary | ≤ 90 s | 36 (72%) | 45 (90%) | ||
| Slow: ≥120 s | 1 (2%) | 5 (10%) | 0 (0%) | ||
| Medium: ≥90 to <120 s | 10 (20%) | 5 (10%) | 5 (10%) | ||
| Fast: <90 s | 36 (72%) | 38 (76%) | 43 (86%) | ||
| FIM ≥4 | 13 (26%) | 20 (40%) | 33 (66%) |
10MWT, ten meter walk test in meters (m); 6MWT, six-minute walk test in seconds (s); TUG, timed up and go in seconds (s); SD, standard deviation; m/s, meters per second; Min, minimum values achieved; Max, maximum value achieved; n, number and %, percent of participants who achieved the criteria; Com, motor complete; Tetra, tetraplegia; Inc, motor incomplete; Para, paraplegia; and FDA, Food and Drug Administration. slow, medium, and fast velocity sub-groups. The velocity sub-groups were defined post hoc after the review of data.
Shaded areas indicate the Primary outcome results for each of the walking tests at 12 and 36 sessions. The FDA criteria was applied only to the ReWalk users because the Ekso is not indicated for personal use.
Modified Functional Independence Measurement (FIM) Scoring Key:.
1, Total Assist (performs <25% of task); 2, Maximal Assist (performs 25 to 49% of task); 3, Moderate Assist (performs 50–74% of task); 4, Minimal Assist (performs 75% or more of task); 5, Supervision (cuing, coaxing, prompting); 6, Modified Independence (no assistance, user may require extra time); 7, Complete Independence (timely, safely, no assistance, no devices), albeit, not applicable in this study.