Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorLaval University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
IMPACT - rehabIlitation prograM for sPAstiC aTaxias
Procedure/SurgeryThe 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Severity of ataxia
The severity of ataxia assessed using the Scale for the assessment and rating of Ataxia (SARA) has been chosen as the main variable based on several considerations. 1) it is one of the most widely used scales among recessive cerebellar ataxias in intervention studies, 2) it includes lower limbs motor impairments-induced mobility limitations items, 3) is significantly correlated with key impairments variables such as standing balance and walking speed, 4) and is a candidate for outcome measurement in foreseeable clinical trials. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia) It showed evidence of adequate content validity and excellent construct validity and internal consistency in ARSACS and we recently validated the French version.
Time frame
64 weeksSecondary outcomes
1
Medication change
Patients will be asked about the possibility of changing their medication. A list of medications will also be provided by the pharmacy.
Time frame
64 weeks2
Weight
Patients weight in kilograms
Time frame
64 weeks3
height
Patients height in meters
Time frame
64 weeks4
Physical activities
The Rapid Assessment of Physical Activity (RAPA) is a questionnaire used to assess physical activity levels. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3)
Time frame
64 weeksSponsors and contacts
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Laval University
Lead sponsor
McGill University
Collaborator
Université de Sherbrooke
Collaborator
Université du Québec a Montréal
Collaborator
University of Calgary
Collaborator
Corporation de recherche et d'action sur les maladies héréditaires (CORAMH)
Collaborator
Cégep de Jonquière
Collaborator
Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-St-Jean
Collaborator
Muscular Dystrophy Canada
Collaborator
University of Alberta
Collaborator
Integrated University Health and Social Services Center of the Capitale-Nationale
Collaborator
Source ClinicalTrials.gov