Rationale and process of the first physiotherapy led randomised placebo controlled drug trial in neurology (EUBOSS)

Abstract

The best of three timed TUG trials, conducted as fast as safely possible, was used in the analysis while the 10MWT with start from a standing position was conducted one time. A 66meter course with two turns was used for the 2MWT (amputees were instructed to walk as far as possible). Amputees used their habitual walking aid, if using any, during all tests. Pearson’s r was used to assess construct validity. Internal responsiveness was assessed by calculating the effect size (ES) as the mean change in performance scores divided by the baseline SD, and the standardized response mean (SRM) as the mean change in scores divided by the SD of changes. Results: Performances improved from 34-85% for all tests; the TUG from a mean (SD) of 34.5 (23.4) seconds to 18.9 (11.3) seconds, the 10MWT from 0.47(0.33) meter per second (m/s) to 0.80 (0.47) m/s and the 2MWT from 58.5 (31.5) meters to 90.4 (44.0)meters. Amputees with a BKA performed the three tests faster (P≤ 0.003), than those with anAKA at both assessments, but with larger improvements seen for the AKA group compared to the BKA group. On the contrary, no significant difference in performance was seen between men and women. Eleven subjects walked 1.0m/s or faster at end of training, which is the speed prerequisite for crossing a green streetlight. The three outcome measures were highly correlated at baseline (r> 0.63, P 0.80, P< 0.001). Responsiveness was high for all tests: TUG (ES 0.67, SRM 1.00), 10MWT (ES 1.00, SRM 1.10) and 2MWT (ES 1.01, SRM 1.15). Conclusion(s): Construct validity and internal responsiveness of the three measures were high, and they all seem able to distinguish between amputee levels. We recommend other centres use the three tests. Implications: Only one-fourth walked faster than 1m/s, supporting the need for studies examining the effect of e.g. progressive strength training for further improvements.