protocolSection identificationModule nctId: NCT06261424, orgStudyIdInfo id: 2024-1426, briefTitle: Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Université du Québec à Chicoutimi, class: OTHER, collaborators name: McGill University, collaborators name: Université de Sherbrooke, collaborators name: Université du Québec a Montréal, collaborators name: Laval University, collaborators name: University of Calgary, collaborators name: Corporation de recherche et d'action sur les maladies héréditaires (CORAMH), collaborators name: Cégep de Jonquière, collaborators name: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-St-Jean, collaborators name: Muscular Dystrophy Canada, collaborators name: University of Alberta, collaborators name: Integrated University Health and Social Services Center of the Capitale-Nationale, descriptionModule 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., conditionsModule conditions: ARSACS, conditions: SPG7, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A multicentre and controlled trial design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo 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, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: IMPACT - rehabIlitation prograM for sPAstiC aTaxias, outcomesModule primaryOutcomes measure: Severity of ataxia, secondaryOutcomes measure: Medication change, secondaryOutcomes measure: Weight, secondaryOutcomes measure: height, secondaryOutcomes measure: Physical activities, secondaryOutcomes measure: Walking speed., secondaryOutcomes measure: Standing balance, secondaryOutcomes measure: Balance confidence, secondaryOutcomes measure: Sitting balance, secondaryOutcomes measure: Activities of Daily Living, secondaryOutcomes measure: Muscle tone, secondaryOutcomes measure: Life habits, secondaryOutcomes measure: Community mobility, secondaryOutcomes measure: Plasma, secondaryOutcomes measure: DNA, secondaryOutcomes measure: Serum, secondaryOutcomes measure: RNA, secondaryOutcomes measure: Urine, secondaryOutcomes measure: Saliva, secondaryOutcomes measure: Mobility Life-space, secondaryOutcomes measure: Ataxia impact scale, secondaryOutcomes measure: Lower limb coordination, secondaryOutcomes measure: Peak respiratory flow and cough, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Falls., secondaryOutcomes measure: Patient-reported impression of change., secondaryOutcomes measure: Anxiety and Depression, secondaryOutcomes measure: Pain characteristics, secondaryOutcomes measure: Functional lower extremity strength, secondaryOutcomes measure: Focus group with intervention group participants, secondaryOutcomes measure: Focus groups with stakeholders, secondaryOutcomes measure: Lower limb muscle activation, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: CBA analyses and Willingness to pay, secondaryOutcomes measure: Gait's temporal parameters, secondaryOutcomes measure: Stance balance, secondaryOutcomes measure: Postural balance, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CIUSSS de la Capitale-Nationale, Hôpital de Baie-Saint-Paul, city: Baie-Saint-Paul, state: Quebec, zip: G3Z 0K3, country: Canada, contacts name: Élise Duchesne, Ph. D., role: CONTACT, email: educhesn@uqac.ca, contacts name: Jacques Beaulieu, commissaire local aux plaintes, role: CONTACT, email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca, contacts name: Xavier Rodrigue, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 47.44109, lon: -70.49858, locations facility: CIUSSS de la Capitale-Nationale, Hôpital de La Malbaie, city: La Malbaie, state: Quebec, zip: G5A 1T1, country: Canada, contacts name: Élise Duchesne, Ph. D., role: CONTACT, email: educhesn@uqac.ca, contacts name: Jacques Beaulieu, commissaire local aux plaintes, role: CONTACT, email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca, geoPoint lat: 47.654, lon: -70.15268, locations 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, contacts name: Élise Duchesne, Ph. D., role: CONTACT, email: educhesn@uqac.ca, contacts name: Céline Roy, commissaire local aux plaintes, role: CONTACT, phone: 514-593-3600, email: commissaireauxplaintes.ccsmtl@ssss.gouv.qc.ca, geoPoint lat: 45.50884, lon: -73.58781, locations facility: CIUSSS de la Capitale-Nationale, installation IRDPQ, city: Québec, state: Quebec, zip: G1M 2S8, country: Canada, contacts name: Élise Duchesne, Ph. D., role: CONTACT, phone: 418-590-3552, contacts name: Jacques Beaulieu, commissaire local aux plaintes, role: CONTACT, email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca, contacts name: Xavier Rodrigue, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations 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, contacts name: Élise Duchesne, role: CONTACT, phone: 418-590-3552, email: educhesn@uqac.ca, contacts name: Julie Bouchard, commissaire local aux plaintes, role: CONTACT, phone: 1 877 662-3963, email: guichetunique.slsj@ssss.gouv.qc.ca, contacts name: Jean-Denis Brisson, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 48.41675, lon: -71.06573, hasResults: False