Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia (NCT05826171) | Clinical Trial Compass
UnknownNot Applicable
Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia
United States20 participantsStarted 2023-02-06
Plain-language summary
PRIME-Ataxia is a randomized controlled trial that aims to determine the feasibility and efficacy of an 8-week telehealth intervention of high intensity aerobic exercise prior to balance training compared to an 8-week telehealth intervention of low intensity exercise prior to balance training in people with spinocerebellar ataxias (SCAs). The investigators additionally aim to explore changes in motor skill learning on a novel motor skill task in a sub-group of participants pre and post intervention.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between the ages of 18 to 85 years
. Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
. Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease
. Able to walk with/without assistive device
. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
. Care partner availability during assessments and/or intervention pending balance scores
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Scale for Assessment and Rating for Ataxia
Timeframe: Baseline, Post-Intervention (4 months)
2
Change in Cerebellar Cognitive Affective Syndrome Scale
Timeframe: Baseline, Post-Intervention (4 months)
3
Change in Patient Reported Outcome Measure for Ataxia
. Severe non-ataxic motor symptoms such as dystonia, tremor, or Parkinsonism, measured by Inventory of Non-Ataxia Signs (INAS)
. Peripheral sensory loss (as confirmed with monofilament or clinical proprioceptive testing)
. Severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7) defined as as have a score on the Snellen Visual Acuity test = 20/200 - 20/400, OR a visual field of 20 degrees of less.
. Musculoskeletal injury that would prevent participation in an exercise program
. Other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
. Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
. Currently engaged in \>3 week moderate-high intensity aerobic exercise and/or balance training