32 Chapter 3 Objectives This study aims to provide an essential step towards evidence-based and individually tailored gait rehabilitation in people with HSP. The objectives are twofold: 1. To study the effect of ten 1-hour sessions of C-Mill training on gait adaptability in people with pure HSP. 2. To identify key determinants of C-Mill training efficacy in people with pure HSP. Methods Regulation statement Move-HSP will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and the Medical Research Involving Human Subjects Act. The protocol is written in accordance with the SPIRIT 2013 checklist. Study design and setting Move-HSP is a five-week, single-center, two-armed, open-label, randomized controlled trial (RCT), with a cross-over design for the control group, as they receive the intervention after a waiting list period. The study is conducted at the Radboud University Medical Centre (Radboudumc) within the Centre of Expertise for Parkinson & Movement Disorders; Nijmegen, The Netherlands. C-Mill training can be given at the Radboudumc (Nijmegen, The Netherlands), Paramedisch centrum Rembrandt (Veenendaal, The Netherlands), Stichting Tante Louise (Bergen op Zoom, The Netherlands) and Fysiotherapiepraktijk De Lindehoeve (Voorschoten, The Netherlands). Other training locations may be added while the study is ongoing, depending on the success of participant inclusion. Recruitment and selection Participants will be recruited at the Center of Expertise for Parkinson & Movement Disorders of the Radboudumc (part of the European Reference Network for Rare Neurological Diseases (ERN-RND)). The treating physician informs the patient about Move-HSP and asks for permission whether the investigator (LV) may contact the patient. In addition, a request to participate will be sent to members of the HSP working group of the patient organization “Spierziekte Nederland”. Those who are interested can contact the investigator and will receive an information letter. After two weeks, the investigator (LV) will contact those who expressed their interest and ask for their final decision. If patients agree to participate, eligibility is checked. After inclusion, participants can leave the study at any time without consequences.
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