nctId: NCT06261424 id: 2024-1426 briefTitle: Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-04 date: 2027-03 date: 2024-02-15 date: 2024-02-15 name: Université du Québec à Chicoutimi class: OTHER name: McGill University name: Université de Sherbrooke name: Université du Québec a Montréal name: Laval University name: University of Calgary name: Corporation de recherche et d'action sur les maladies héréditaires (CORAMH) name: Cégep de Jonquière name: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-St-Jean name: Muscular Dystrophy Canada name: University of Alberta name: Integrated University Health and Social Services Center of the Capitale-Nationale briefSummary: Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT \[rehabIlitation prograM for sPAstiC aTaxias\]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide. conditions: ARSACS conditions: SPG7 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A multicentre and controlled trial design. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: All participants will be assessed at their respective neuromuscular clinic (Saguenay, Quebec, Montreal or Calgary) by physiotherapists trained according to standard operating procedures (SOP). These physiotherapists will not be involved in the supervision of the program and will be blinded. whoMasked: CARE_PROVIDER count: 84 type: ESTIMATED name: IMPACT - rehabIlitation prograM for sPAstiC aTaxias measure: Severity of ataxia measure: Medication change measure: Weight measure: height measure: Physical activities measure: Walking speed. measure: Standing balance measure: Balance confidence measure: Sitting balance measure: Activities of Daily Living measure: Muscle tone measure: Life habits measure: Community mobility measure: Plasma measure: DNA measure: Serum measure: RNA measure: Urine measure: Saliva measure: Mobility Life-space measure: Ataxia impact scale measure: Lower limb coordination measure: Peak respiratory flow and cough measure: Fatigue measure: Falls. measure: Patient-reported impression of change. measure: Anxiety and Depression measure: Pain characteristics measure: Functional lower extremity strength measure: Focus group with intervention group participants measure: Focus groups with stakeholders measure: Lower limb muscle activation measure: Quality of life measure: CBA analyses and Willingness to pay measure: Gait's temporal parameters measure: Stance balance measure: Postural balance sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CIUSSS de la Capitale-Nationale, Hôpital de Baie-Saint-Paul city: Baie-Saint-Paul state: Quebec zip: G3Z 0K3 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT email: educhesn@uqac.ca name: Jacques Beaulieu, commissaire local aux plaintes role: CONTACT email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca name: Xavier Rodrigue, M.D. role: SUB_INVESTIGATOR lat: 47.44109 lon: -70.49858 facility: CIUSSS de la Capitale-Nationale, Hôpital de La Malbaie city: La Malbaie state: Quebec zip: G5A 1T1 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT email: educhesn@uqac.ca name: Jacques Beaulieu, commissaire local aux plaintes role: CONTACT email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca lat: 47.654 lon: -70.15268 facility: CIUSSS du Centre-Sud-de-l'Île-de-Montréal, installation Centre de réadaptation Lucie-Bruneau city: Montréal state: Quebec zip: H2H 2N8 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT email: educhesn@uqac.ca name: Céline Roy, commissaire local aux plaintes role: CONTACT phone: 514-593-3600 email: commissaireauxplaintes.ccsmtl@ssss.gouv.qc.ca lat: 45.50884 lon: -73.58781 facility: CIUSSS de la Capitale-Nationale, installation IRDPQ city: Québec state: Quebec zip: G1M 2S8 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT phone: 418-590-3552 name: Jacques Beaulieu, commissaire local aux plaintes role: CONTACT email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca name: Xavier Rodrigue, M.D. role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: Clinique des maladies neuromusculaires du Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Saguenay-Lac-Saint-Jean, installation Hôpital Jonquière city: Saguenay state: Quebec zip: G7X 7X2 country: Canada name: Élise Duchesne role: CONTACT phone: 418-590-3552 email: educhesn@uqac.ca name: Julie Bouchard, commissaire local aux plaintes role: CONTACT phone: 1 877 662-3963 email: guichetunique.slsj@ssss.gouv.qc.ca name: Jean-Denis Brisson, M.D. role: SUB_INVESTIGATOR lat: 48.41675 lon: -71.06573 hasResults: False