A Home-based Rehabilitation Program to Counter the Motor Impairments and Activity Limitations Experienced by People With Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in sitting balance
研究概览
简要总结
48 participants (24 women and 24 men) with autosomal recessive spastic ataxia of Charlevoix-Saguenay (ARSACS) will participate in 2 phases : control phase (12-week usual care) and intervention phase (12-week home-based rehabilitation program). The participants will be evaluated at baseline, week 12 (end of control phase) and week 24 (end of intervention phase) to quantify the effects of an individualized home-based rehabilitation program. Participants will also participate on a focus group at the end of the program to evaluate the acceptability of the program and the perceived changes.
详细描述
Co-creation phase:
Preceding the intervention, a co-creation phase involving healthcare professionals (3), patient-partners (2), and ARSACS researchers (3) will be conducted to develop the exercises for the rehabilitation program and the evaluation scale to determine the level of difficulty of each exercise assigned to participants.
Intervention phase:
Random sampling stratified by gender and level of indoor mobility (unassisted walking, assisted walking, wheelchair) from the Neuromuscular Clinic's registry of 48 participants (24 women and 24 men) will be conducted.
- Control phase: All participants will be asked to maintain their usual activities for 12 weeks.
- Intervention phase: All participants recruited to the project will complete the home-based rehabilitation program assigned to them for 12 weeks, unsupervised, 20 minutes 3 times a week. Follow-up calls by a physiotherapist will be conducted at weeks 2, 4, 6, 8, 10 and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ARSACS diagnosis must be confirmed by genetic analysis;
- •Women and men, aged between 18 and 50 years old;
- •Be able to perform the sit-to-stand transfer;
- •Consent of the neurologist must be given to participate in this study;
- •Must reside in the Saguenay-Lac-St-Jean region;
- •Subjects must be able to give their consent freely and voluntarily.
排除标准
- •Patients who already meet physical activity (PA) recommendations (150 min of moderate to high intensity PA/week) or already participate in a rehabilitation program are excluded;
- •Remain in a care facility;
- •Do not speak English or French;
- •Have another diagnosis causing physical limitations;
- •Are pregnant.
结局指标
主要结局
Change in sitting balance
时间窗: Baseline, week 12, week 24
Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome
Change in walking speed
时间窗: Baseline, week 12, week 24
Change in the walking speed, measured with the time to walk 10 meters at self-selected and maximum speed
Change in balance
时间窗: Baseline, week 12, week 24
Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance
次要结局
- Change in the time required to descent 10 stairs(Baseline, week 12, week 24)
- Change in the balance confidence(Baseline, week 12, week 24)
- Change in the number of falls(Baseline, week 12, week 24)
- Change in mobility components(Week 12, week 24)
- Sum of lower limb muscle spasticity(Baseline, week 12, week 24)
- Change in the lower limb coordination(Baseline, week 12, week 24)
- Change in the number of sit-to-stand performed in 30 seconds(Baseline, week 12, week 24)
- Change in the time required to ascent 10 stairs(Baseline, week 12, week 24)
- Change in social participation(Baseline, week 12, week 24)
- Change in the knee extensor muscle group spasticity(Baseline, week 12, week 24)
- Change in the life space(Baseline, week 12, week 24)
- Change in the upper limb coordination(Baseline, week 12, week 24)
- Measure of the usability of the program and hardware(Week 24)
- Change in the adductor hip muscle group spasticity(Baseline, week 12, week 24)
- Change in the plantar flexor muscle group spasticity(Baseline, week 12, week 24)
- Change in the knee flexor muscle group spasticity(Baseline, week 12, week 24)
- Change in the Scale for the assessement and rating of ataxia (SARA)(Baseline, week 12, week 24)
- Change in sleep components(Week 12, week 24)
研究者
Cynthia Gagnon
Professor
Université de Sherbrooke