Clinical trial NCT05826171: Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia
Official title: Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia: a Randomized Controlled Trial (PRIME-Ataxia RCT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinocerebellar Ataxia Type 1
Spinocerebellar Ataxia Type 2
Spinocerebellar Ataxia Type 3
Spinocerebellar Ataxia Type 6
Spinocerebellar Ataxia Type 7
Keywords: Aerobic Exercise
Balance
Motor Learning
Neurorehabilitation
Telehealth
Spinocerebellar Ataxia
Physical Therapy
Rehabilitation
Cerebellum
High intensity aerobic exercise
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: The PRIME-Ataxia randomized controlled trial involves 2 groups of participants (n=20). One group (high intensity exercise + balance) will receive high intensity aerobic exercise followed by balance training, and another group (low intensity exercise + balance) will receive low intensity exercise (stretching, warm up exercises) followed by balance training. Both groups will undergo four remote assessments (2 baseline assessments, a mid-intervention assessment, and a post-intervention assessment). A subset of individuals (n=12) from both groups will undergo an in-person assessment on a novel motor task, along with digital posturography assessment of standard functional assessments of mobility and balance at baseline 1 (week 0), and post-intervention (week 16).

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 to 85 years
2. Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
3. Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease
4. Able to walk with/without assistive device
5. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
6. Care partner availability during assessments and/or intervention pending balance scores

Exclusion Criteria:

1. Severe non-ataxic motor symptoms such as dystonia, tremor, or Parkinsonism, measured by Inventory of Non-Ataxia Signs (INAS)
2. Peripheral sensory loss (as confirmed with monofilament or clinical proprioceptive testing)
3. 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.
4. Musculoskeletal injury that would prevent participation in an exercise program
5. Other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
6. Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
7. Currently engaged in \>3 week moderate-high intensity aerobic exercise and/or balance training

Primary outcomes:
measure: Change in Scale for Assessment and Rating for Ataxia
timeFrame: Baseline, Post-Intervention (4 months)
measure: Change in Cerebellar Cognitive Affective Syndrome Scale
timeFrame: Baseline, Post-Intervention (4 months)
measure: Change in Patient Reported Outcome Measure for Ataxia
timeFrame: Baseline, Post-Intervention (4 months)
Secondary outcomes:
measure: Activities Specific Balance Scale (ABC)
timeFrame: Baseline, Post-Intervention (4 months)
measure: Digital Biomarker of Static Posturography
timeFrame: Baseline, Post-Intervention (4 months)
measure: Digital Biomarker of Dynamic Posturography
timeFrame: Baseline, Post-Intervention (4 months)
measure: Motor Adaptation
timeFrame: Baseline, Post-Intervention (4 months)
measure: Neurological Quality of Life
timeFrame: Baseline, Post-Intervention (4 months)
measure: Patient Global Impression of Change
timeFrame: Baseline, Post-Intervention (4 months)
measure: Acceptability Questionnaire
timeFrame: Baseline, Post-Intervention (4 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Teachers College, Columbia University
name: Lori Quinn, PT, EdD
role: PRINCIPAL_INVESTIGATOR
affiliation: Teachers College, Columbia University
name: Chelsea E Macpherson, DPT
role: PRINCIPAL_INVESTIGATOR
References: