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Walking-adaptability therapy after stroke: results of a randomized controlled trial
Timmermans C, Roerdink M, Meskers CGM, Beek PJ, Janssen TWJ
Trials 2021 Dec 15;22(923):Epub
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The ability to adapt walking to environmental properties and hazards, a prerequisite for safe ambulation, is often impaired in persons after stroke. RESEARCH QUESTION: The aim of this study was to compare the efficacy of two walking-adaptability interventions: a novel treadmill-based C-Mill therapy (using gait-dependent augmented reality) and the standard overground FALLS program (using physical context). We expected sustained improvements for both treatment groups combined but hypothesized better outcomes for C-Mill therapy than the FALLS program due to its expected greater amount of walking practice. METHODS: In this pre-registered single-centre parallel group randomized controlled trial, forty persons after stroke (>= 3 months ago) with walking and/or balance deficits were randomly allocated to either 5 weeks of C-Mill therapy or the FALLS program. The primary outcome measure was the standard walking speed as determined with the 10-meter walking test (10MWT). Additionally, context-specific walking speed was assessed in environments enriched with either stationary physical context (10MWT context) or suddenly appearing visual images (Interactive Walkway obstacles). The walking-adaptability scores of those enriched walking tests served as secondary outcome measures. Furthermore, a cognitive task was added to all three assessments to evaluate dual-task performance in this context. Finally, the participants' experience and amount of walking practice were scored. The outcome measures were assessed at four test moments: pre-intervention (T0), post-intervention (T1), 5-week post-intervention retention (T2), and 1-year post-intervention follow-up (T3). RESULTS: No significant group differences were found between the interventions for the primary outcome measure standard walking speed, but we found a greater improvement in context-specific walking speed with stationary physical context of the C-Mill therapy compared to the FALLS program at the post-intervention test, which was no longer significant at retention. Both interventions were well received, but C-Mill therapy scored better on perceived increased fitness than the FALLS program. C-Mill therapy resulted in twice as many steps per session of equal duration than the FALLS program. The "change-over-time" analyses for participants of both interventions combined showed no significant improvements in the standard walking speed; however, significant improvements were found for context-specific walking speed, walking adaptability, and cognitive dual-task performance. SIGNIFICANCE: This study showed no between-group differences between the novel treadmill-based C-Mill therapy and the standard overground FALLS program with respect to the primary outcome measure standard walking speed. However, the greater amount of walking practice observed for the C-Mill group, an essential aspect of effective intervention programs after stroke, may underlie the reported increased perceived fitness and observed increased context-specific walking speed for the C-Mill group directly after the intervention. Although the "change-over-time" results for all participants combined showed no improvement in the standard walking speed, context-specific walking speed and walking adaptability showed sustained improvements after the interventions, underscoring the importance of including walking-adaptability training and assessment in rehabilitation post stroke. TRIAL REGISTRATION: The Netherlands Trial Register NTR4030. Registered 11 June 2013.

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