52 Chapter 4 Methods Study design and setting We conducted a five-week, randomized clinical trial, with a cross-over design for the waiting-list control group, and a fifteen-week follow-up period after the intervention. This mono-center study was conducted at the Centre of Expertise for Rare and Genetic Movement Disorders of the Radboud University Medical Centre (Nijmegen, The Netherlands), which is part of the European Reference Network for Rare Neurological Diseases (ERN-RND). Ethical approval was obtained from the Medical Ethical Committee Oost-Nederland, the Netherlands (2019-5602, NL70295.091.19). The trial was registered on Clinicaltrials.gov (NCT04180098) and the study protocol has previously been published.14 All participants signed informed consent. Participants were randomized via a web-based randomization system into two groups: i) gait-adaptability training group: five weeks of C-Mill training next to usual care; or ii) waiting-list control group receiving five weeks of usual care. Randomization was done following a 1:1 ratio with randomly varying blocks (n=4 or n=6) and stratified by disease duration (2 categories: 0-15 years and >15 years). Participants in the gait-adaptability training group were assessed three times; pre training, post training, and at follow-up. Participants assigned to the waiting-list control group crossed over to five weeks of gait-adaptability training following five weeks of usual care. Therefore, participants in the waiting-list control group were assessed four times: pre waiting list, pre training, post training, and at follow-up. A detailed flowchart of the study design is available in the previously published protocol paper.14 The assessments took place at the movement laboratory of the Radboud University Medical Centre (Nijmegen, The Netherlands). The gaitadaptability training sessions were executed at four sites: Radboud University Medical Centre (Nijmegen, NL), Paramedisch centrum Rembrandt (Veenendaal, NL), Stichting Tante Louise (Bergen op Zoom, NL), and Fysiotherapie de Lindehoeve (Voorschoten, NL). Participants could not be blinded, as they unavoidably knew whether they received gait-adaptability training or not. The assessor (LV) conducting the measurements at the movement laboratory also provided the training sessions at Radboud University Medical Centre and could, therefore, not be blinded either. During the trial, all participants were allowed to continue with usual care (e.g., physical therapy). Participants Participants were recruited via the outpatient clinic of the Centre of Expertise for Rare and Genetic Movement Disorders of the Radboud University Medical Centre and via the Dutch HSP working group of the patient organization “Spierziekte Nederland”. Inclusion criteria were (1) diagnosis of pure HSP by a neurologist specialized in genetic movement disorders, (2) aged between 18-70 years old, and (3) ability to walk barefoot on a level ground without a walking aid (use of
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