Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias

Université du Québec à Chicoutimi

Status: Enrolling

Conditions: Spastic Paraplegia 7; Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay

Treatments: Procedure: IMPACT - rehabIlitation prograM for sPAstiC aTaxias

Study type: Interventional

Funder types: Other

Identifiers

NCT06261424

2024-1426

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Intervention group

Experimental group

Description:

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).

Treatment:

Procedure: IMPACT - rehabIlitation prograM for sPAstiC aTaxias