Table III.
Walk test and change at baseline and follow-up
| Ambulation | Baseline | 3 months | 6 months | 12 months | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 10mWT gait velocity (m/s) | |||||||||||
| Phase III trial (n = 10) | 0.71 | (0.23) | 0.75 | (0.24) | 0.76 | (0.28) | 0.78 | (0.32) | |||
| Clinical group (n = 11) | 0.74 | (0.37) | 0.83 | (0.38) | n.p. | 0.87 | (0.41) | ||||
| Danish ActiGait® cohort (n = 21) | 0.73 | (0.30) | 0.79 | (0.32) | n.p. | 0.83 | (0.36) | ||||
| 6 MWT distance (m) | |||||||||||
| Phase III trial (n = 10) | 232 | (74) | 242 | (80) | 244 | (90) | 256 | (93) | |||
| Clinical group (n = 11) | 239 | (120) | 263 | (127) | n.p. | 281 | (124) | ||||
| Danish ActiGait® cohort (n = 21) | 236 | (98) | 253 | (105) | n.p. | 269 | (108) | ||||
|
| |||||||||||
| Change (follow-up – baseline) | Diff | p-value | Diff | p-value | Diff | p-value | |||||
|
| |||||||||||
| 10mWT gait velocity (m/s) | |||||||||||
| Phase III trial (n = 10) | 0.03 | [–0.04–0.1] | 0.34 | 0.05 | [–0.05–0.2] | 0.27 | 0.07 | [–0.04–0.2] | 0.19 | ||
| Clinical group (n = 11) | 0.09 | [0.03–0.2] | 0.006 | n.p. | n.p. | 0.13 | [0.02–0.2] | 0.03 | |||
| Danish ActiGait® cohort (n = 21) | 0.07 | [0.02–0.1] | 0.007 | n.p. | n.p. | 0.1 | [0.03–0.2] | 0.01 | |||
| 6 MWT distance (m) | |||||||||||
| Phase III trial (n = 10) | 9 | [–13–32] | 0.32 | 12 | [–12–35] | 0.29 | 24 | [–6–53] | 0.11 | ||
| Clinical group (n = 11) | 24 | [5–44] | 0.02 | n.p. | n.p. | 42 | [18–67] | 0.003 | |||
| Danish ActiGait® cohort (n = 21) | 17 | [3–31] | 0.017 | n.p. | n.p. | 33 | [15–51] | < 0.001 | |||
Data in the upper panel are reported as means (SD).
Change at follow-up in the lower panel are reported as means [95% confidence interval; 95% CI].
10mWT: 10-m walk test; 6MWT:6-min walk test.
n.p.: not performed; Diff: Difference between follow-up and baseline
Phase III trial participants: 10 individuals participating in a previous published clinical trial (reference 11).
Clinical group: 11 individuals implanted with the ActiGait® device after completion of the phase III trial. Danish ActiGait® cohort constitutes all phase III trial participants (n = 10) and all individuals in the Clinical group (n = 11).