54 Chapter 4 over an eight-meter walkway with their own comfortable shoes. From the gait analysis, average stride length (m), average stride time (s), average step width (m), walking speed (m/s) and cadence (steps/min) were extracted. The assessments were conducted by a trained investigator using a standardized protocol. Details on how the outcome measures were assessed have been published in the study protocol.14 Use of orthotic devices, including orthopedic footwear, was allowed and kept consistent throughout the different assessments. Furthermore, levels of physical activity were measured following each assessment during seven consecutive days with activity monitors (Activ8, Remedy Distribution Ltd., Valkenswaard, The Netherlands). Physical activity was expressed as total time spent walking and total time spent active (i.e., minutes classified as walking, running or cycling). Lastly, during 15 weeks prior to the first assessment and during fifteen weeks following gait-adaptability training, all participants self-reported their falls and near-falls in a digital fall diary. Falls that occurred during these fall diary periods were considered to be outcomes. In contrast, falls that were registered during the five weeks gait-adaptability training or during the five weeks on the waiting-list were considered as adverse events. Sample Size Sample size calculation is based on previous studies evaluating the effectiveness of C-Mill training on the obstacle subtask of the E-FAP (these studies involved stroke patients 9 and people with ataxia 12). To detect an improvement of 1.75 seconds on the E-FAP obstacle subtask (SD: 2.0s) and applying an α = 0.05 and β = 0.2, 16 participants per group would be needed. Allowing a 10% attrition rate, we aimed for a total of 36 participants.14 Statistical analysis The effects of gait-adaptability training on the primary and secondary outcome measures were assessed by comparing the post-intervention scores through analysis of covariance (ANCOVA). The baseline score of the corresponding primary and secondary outcomes was entered into the model as a covariate. Analyses were based on the intention-to-treat principle. In second instance, both groups were merged based on their corresponding pre-training, post-training, and follow-up assessments (i.e., assessments 1, 2 and 3 for the gait-adaptability training group and assessments 2, 3 and 4 for the waiting-list control group). Time effects during and after gait-adaptability training were then assessed with a repeated-measures analysis of variance (ANOVA) using time as a within-subjects factor. Post-hoc testing with paired t-tests was done to assess whether outcomes differed between the post- vs. pre-training assessments, and between the follow-up vs. post-training assessments. The fall dairies were processed descriptively.
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