33 Protocol: gait-adaptability training in people with HSP Eligibility For inclusion, participants will have to meet the following inclusion criteria: • Diagnosis of pure HSP by a neurologist specialized in inherited movement disorders. Diagnosis is based on inheritance pattern and clinical examination, and when available, molecular diagnosis, • age between 18-70 years old, • ability to walk barefoot on a level ground for 50 meters without a walking aid (use of orthotic devices or orthopedic shoes is allowed). Participants will be excluded if they suffer from other neurological, orthopedic or psychiatric conditions, or if patients underwent an HSP-related surgical procedure of the lower extremities. Group allocation and blinding Participants will be allocated at random to the intervention group or to the (waiting list) control group following a 1:1 ratio. Randomization will be stratified based on disease duration (2 categories: 0-15 years; >15 years) in blocks with a variable size (n=4 or n=6) to prevent an uneven distribution between groups. To determine disease duration, participants are asked for the year of symptom onset. Randomization will be performed in CastorEDC, a web-based data management system for academic studies (www.castoredc.com). Blinding of participants is not possible, as participants will know whether they receive C-Mill training or continue with usual care. The primary investigator (LV) takes part in the training sessions as a physical therapist and, therefore, cannot be blinded either. Participant timeline The outline of this study is shown in Figure 1. Following inclusion, participants are randomly allocated to either the intervention group or the control group (waiting list). During the first fifteen weeks, all participants register (near) falls in a digital fall calendar. Thereafter, participants will have the first assessment at the movement laboratory (Radboudumc; week 16). Following this assessment, participants wear an Activ8 activity monitor for seven consecutive days (week 16). Thereafter, the control group enters a waiting period of five weeks (week 17-21), whereas the intervention group starts with five weeks of gait adaptability training on the C-Mill (Week 17-21). Each session lasts one hour and takes place twice per week. Subsequently, both groups are re-assessed (week 22) Following this second assessment, the intervention group enters the follow-up period, whereas the control group wears the Activ8 activity monitors for seven days (week 22), starts five weeks of gait adaptability training (week 23-27), has the third assessment (week 28), and, thereafter, enters the follow-up period. During follow-up, both groups wear Activ8 activity monitors during the first week (intervention group: week 23, control group: week 29) and, 3
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