| Region of interest -1 | Region of interest-2 | All regions of interest combined | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Time point | Active insole Mean MPPP kPa (sd) | Optimised insole Mean MPPP kPa (sd) | Mean MPPP difference unadjusted for baseline kPa(CI*) | Mean MPPP difference adjusted for baseline kPa(CI*) | Active insole Mean MPPP kPa (sd) | Optimised insole Mean MPPP kPa (sd) | Mean MPPP difference unadjusted for baseline kPA (CI*) | Mean MPPP difference adjusted for baseline kPA (CI*) | Mean MPPP difference unadjusted for baseline kPA (CI*) | Mean MPPP difference adjusted for baseline kPA (CI*) |
Baseline | 564.0 (223.0) | 583.3 (220.9) | n/a | n/a | 499.4 (240.4) | 583.3 (220.9) | n/a | n/a | n/a | n/a |
Immediately post randomisation | 447.4 (181.9) | 370.2 (162.1) | 96.3 (CI 29.4, 163.3) | 89.2 (CI − 36.7, 141.7) | 452.7 (252.2) | 360.9 (157.3) | 161.5 (CI 37.1, 285.9) | 136.7 (CI 26.8, 246.6) | 100.5 (CI 36.6, 164.4) | 87.9 (CI 40.1, 135.7) |
3-month follow-up | 546.1 (229.6) | 495.9 (244.4) | 123.7 (CI − 286.4, 39.0) | 77.3 (CI − 61.5, 216.2) | 648.6 (378.9) | 495.9 (244.4) | 203.1 (CI − 13.6, 419.9) | 187.3 (CI − 28.8, 403.5) | 155.4 (CI 11.4, 299.5) | 122.2 (CI − 5.0, 249.5) |
6-month follow-up | 639.8 (332.3) | 625.3 (353.8) | 51.4 (CI − 140.3, 243.1) | 44.5 (CI − 148.5, 237.5) | 717.0 (476.6) | 525.3 (253.8) | 247.7 (CI 3.5, 491.8) | 283.9 (CI 36.0, 531.8) | 124.2 (CI − 53.0, 301.3) | 112.0 (CI − 63.4, 287.4) |
12-month follow-up | 854.7 (538.9) | 596.2 (437.6) | 238.9 (CI − 32.1, 509.9) | 239.4 (CI − 35.4, 514.2) | 797.1 (592.7) | 596.2 (437.6) | 252.4 (CI − 61.0, 565.8) | 283.6 (CI − 55.9, 623.1) | 257.9 (CI 15.9, 500.0) | 255.5 (CI 10.1, 501.0) |