Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia (EngageAtaxia)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 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
Engage-Ataxia will implement a physical activity coaching program for people with cerebellar ataxia at Teachers College, Columbia University. This program expands upon the current Engage program for people with Parkinson's disease (Engage-PD), an exercise coaching program for people with early stage Parkinson's disease to target individuals with early stage cerebellar ataxia. Engage-Ataxia will utilize a physical or occupational therapist to provide up to five one-on-one coaching sessions for individuals newly diagnosed with cerebellar ataxia. Therapists will work with participants to provide individualized structured support to facilitate and optimize exercise uptake as one part of comprehensive disease management. Participants will undertake two assessments three months apart, and will receive coaching interventions via Zoom healthcare platform. The primary objective of this program is to increase physical activity and exercise engagement in individuals with early stage cerebellar ataxia. This feasibility study will provide preliminary data and insight into the benefits of a remote coaching intervention for people with cerebellar ataxia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Neurologist confirmed diagnosis of cerebellar ataxia
- •Scale for Ataxia Rating and Assessment (SARA) score between 8-25 (total score of 40), which will capture mild to moderate stage of the disease
- •Ambulatory for indoor and outdoor mobility without assistance or assistive device
- •Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) or medical clearance from primary doctor
- •Medical clearance to exercise
排除标准
- •Musculoskeletal injury that would prevent participation in an exercise program
- •Other neurological disease or disorder such as stroke
- •Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
- •Metabolic conditions that would affect participants during an exercise program
- •Currently do moderate-vigorous exercise 5 days a week or more
结局指标
主要结局
Change in Scale for Assessment and Rating for Ataxia
时间窗: Baseline, Post-Intervention (3 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 modified version of the SARA, and be using the first four items of the SARA Scale (Gait, Stance, Walking, Speech) to be administered via telehealth.
Change in Brunel Lifestyle Physical Activity Questionnaire
时间窗: Baseline, Post-Intervention (3 months)
Evaluates both pre-planned and unplanned physical activity. Both pre-planned and unplanned physical activity subsections are separately scored through summation and average. Higher averages (closer to 5) indicate greater physical activity, whereas lower averages (closer to 0) indicate little to no physical activity in either category.
Change in Cerebellar Cognitive Affective Syndrome Scale
时间窗: Baseline, Post-Intervention (3 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
- Activities Specific Balance Scale (ABC)(Baseline, Post-Intervention (3 months))
- Digital Biomarker of Static Posturography(Baseline, Post-Intervention (3 months))
- Exercise Identity Scale Exercise Identity Scale(Baseline, Post-Intervention (3 months))
- The Self- Efficacy for Exercise Scale(Baseline, Post-Intervention (3 months))
- Digital Biomarker of Dynamic Posturography(Baseline, Post-Intervention (3 months))
- Acceptability Questionnaire(Post-intervention (3 months))