Recruiting

Rehabilitation Program

Sponsor:

Laval University

Code:

NCT06261424

Conditions

Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay

Spastic Paraplegia 7

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

IMPACT - rehabIlitation prograM for sPAstiC aTaxias

Study Details

Brief summary:

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

Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay

Spastic Paraplegia 7

Study ID

NCT06261424

Start date

Feb 1, 2024

Status verified date

Dec, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • have a confirmed genetic diagnosis of ARSACS or SPG7
  • be able to maintain standing position and to transfert
  • be authorized by their treating neurologist
  • speak French or English
  • be able to give informed consent.

Exclusion Criteria:

  • have active participation in a rehabilitation program (self-reported information)
  • have another condition causing physical limitations
  • be uncomfortable in a swimming pool
  • be pregnant.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control group

The control group will receive their usual care and will be asked to continue their usual activities and exercises for the whole project duration. Only one clinical guide exists for ataxia interventions and no specific guidelines for physiotherapy and occupational therapy interventions are specified in this guide in terms of frequency, duration and type of interventions that are effective with this population. Patients generally have an annual follow-up with a doctor or a clinical nurse at a Neuromuscular Diseases Clinic. Patients are then referred if needed for follow-up with the physiotherapist and occupational therapist. Typically, patients are referred to physiotherapy for mobility-related needs such as the introduction of a walking aid, orthotic and sometimes teaching an exercise program. In occupational therapy, patients are referred for needs such as the introduction of technical aids, home adaptation or the introduction of a wheelchair.

experimental: Intervention group

The intervention group will follow a 12-week rehabilitation program, 3 times a week (two sessions in a therapy room and one session of aquatherapy).

Interventions

IMPACT - rehabIlitation prograM for sPAstiC aTaxias

The rehabilitation program will last 12 weeks and consists of three training sessions of 60 minutes per week (2 sessions in a therapy room and 1 session in an adapted pool with multiple levels of water) for a total of 36 sessions. Participants will be divided into 7 subgroups of 6 participants and each sub-group will be supervised by one physiotherapist (PT) and one physiotherapy technologist for safety considerations. It will focus on these three domains: 1) postural control; balance, trunk-limbs and multi-joints control and coordination and 3) functional mobility. Each domain contains a standardized list of exercises with different difficulty levels and specific times allocation. All exercises will be executed by the participants at each session at the appropriate difficulty level. The initial level of difficulty for each exercise will be determined by the PT based on individual results of the pre-intervention assessment and on individual performance, fatigue level and safety.

Primary outcome measure

  • Severity of ataxia [ Time Frame: 64 weeks ]

Central Contacts and Locations

Central contacts

Elise Duchesne, Ph D.

418-590-3552educhesn@uqac.ca

Andrée Hardy

418 541-1234guichetunique.slsj@ssss.gouv.qc.ca

Locations

CIUSSS du Centre-Sud-de-l'Île-de-Montréal, installation Centre de réadaptation Lucie-Bruneau

Recruiting

Montreal, Quebec, Canada, H2H 2N8

Contacts

Élise Duchesne, Ph. D.

educhesn@uqac.ca

Céline Roy, commissaire local aux plaintes

514-593-3600commissaireauxplaintes.ccsmtl@ssss.gouv.qc.ca

CIUSSS de la Capitale-Nationale, installation IRDPQ

Recruiting

Québec, Quebec, Canada, G1M 2S8

Contacts

Élise Duchesne, Ph. D.

418-590-3552

Jacques Beaulieu, commissaire local aux plaintes

commissaire.plainte.ciussscn@ssss.gouv.qc.ca

Clinique des maladies neuromusculaires du Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Saguenay-Lac-Saint-Jean, installation Hôpital Jonquière

Recruiting

Saguenay, Quebec, Canada, G7X 7X2

Contacts

Élise Duchesne

418-590-3552educhesn@uqac.ca

Julie Bouchard, commissaire local aux plaintes

1 877 662-3963guichetunique.slsj@ssss.gouv.qc.ca

More Information

Sponsor

Laval University

Last update posted

Feb 18, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2026-02-18.