Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia: a Randomized Controlled Trial (PRIME-Ataxia RCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Scale for Assessment and Rating for Ataxia
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Scale for Assessment and Rating for Ataxia
时间窗: Baseline, Post-Intervention (4 months)
Clinical rating scale for severity of ataxia symptoms. This is an 8-item clinical performance based scale, which individuals are graded according to total ataxia severity. Total scores can range from 0 (no ataxia) to 40 (most severe ataxia). Scores are based on performance of the following tasks: 1) Gait, 2) Stance, 3), Sitting, 4) Speech Disturbance, 5) Finger Chase, 6) Nose-Finger Test, 7) Fast alternating hand movements, 8) Heel-shin slide. For the purpose of this study, we will be performing a validated modified version of the SARA, referred to as the SARAHome. The SARAHome is comprised of the first four items and item 6 from the original SARA Scale (Gait, Stance, Walking, Speech, and Nose-Finger Test) and it will be administered via telehealth.
Change in Patient Reported Outcome Measure for Ataxia
时间窗: Baseline, Post-Intervention (4 months)
Patient reported outcome measure for people with ataxia. The test was developed to assess 3 domains (physical, activities of daily living, mental health) and 14 subdomains. It has been proven to be valid and reliable against measures of motor ataxia, mental health, and quality of life. The original Patient Reported Outcome Measure for Ataxia has 70 questions, and records a total score out of 280 possible points. For the purpose of this trial, we will use the Short-Form version of this assessment which asks 10 questions, and it scored out of a total of 40 possible points.
Change in Cerebellar Cognitive Affective Syndrome Scale
时间窗: Baseline, Post-Intervention (4 months)
The Cerebellar Cognitive Affective Syndrome Scale (CCAS) was developed as a bedside quick screen for Cerebellar Cognitive Affective Symptom (also referred to as Schmalmann's Syndrome). The CCAS is a 10-item scale of cognitive and neuropsychiatric tests detailing executive function, working and verbal memory, language, visuospatial function, abstract reasoning, behavior and affect. Two scores are reported; a raw score ranging from 0 (severe cognitive impairment) to 120 points (no cognitive impairment), as well as a Pass/Fail marker for each of the 10 items on the scale. 1 fail is considered as possible cerebellar cognitive affective symptom, 2 fails are considered probable, and 3 fails are considered clinically definite.
次要结局
- Patient Global Impression of Change(Baseline, Post-Intervention (4 months))
- Activities Specific Balance Scale (ABC)(Baseline, Post-Intervention (4 months))
- Digital Biomarker of Static Posturography(Baseline, Post-Intervention (4 months))
- Digital Biomarker of Dynamic Posturography(Baseline, Post-Intervention (4 months))
- Acceptability Questionnaire(Baseline, Post-Intervention (4 months))
- Neurological Quality of Life(Baseline, Post-Intervention (4 months))
- Motor Adaptation(Baseline, Post-Intervention (4 months))