IMPACT, a Supervised Rehabilitation Program for Spastic Ataxias: A Rater-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 5
- 主要终点
- Severity of ataxia
研究概览
简要总结
Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT [rehabIlitation prograM for sPAstiC aTaxias]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
All participants will be assessed at their respective neuromuscular clinic (Saguenay, Quebec, Montreal or Calgary) by physiotherapists trained according to standard operating procedures (SOP). These physiotherapists will not be involved in the supervision of the program and will be blinded.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a confirmed genetic diagnosis of ARSACS or SPG7
- •be able to maintain standing position and to transfert
- •be authorized by their treating neurologist
- •speak French or English
- •be able to give informed consent.
排除标准
- •have active participation in a rehabilitation program (self-reported information)
- •have another condition causing physical limitations
- •be uncomfortable in a swimming pool
- •be pregnant.
研究组 & 干预措施
Control group
The control group will receive their usual care and will be asked to continue their usual activities and exercises for the whole project duration. Only one clinical guide exists for ataxia interventions and no specific guidelines for physiotherapy and occupational therapy interventions are specified in this guide in terms of frequency, duration and type of interventions that are effective with this population. Patients generally have an annual follow-up with a doctor or a clinical nurse at a Neuromuscular Diseases Clinic. Patients are then referred if needed for follow-up with the physiotherapist and occupational therapist. Typically, patients are referred to physiotherapy for mobility-related needs such as the introduction of a walking aid, orthotic and sometimes teaching an exercise program. In occupational therapy, patients are referred for needs such as the introduction of technical aids, home adaptation or the introduction of a wheelchair.
Intervention group
The intervention group will follow a 12-week rehabilitation program, 3 times a week (two sessions in a therapy room and one session of aquatherapy).
干预措施: IMPACT - rehabIlitation prograM for sPAstiC aTaxias (Procedure)
结局指标
主要结局
Severity of ataxia
时间窗: 64 weeks
The severity of ataxia assessed using the Scale for the assessment and rating of Ataxia (SARA) has been chosen as the main variable based on several considerations. 1) it is one of the most widely used scales among recessive cerebellar ataxias in intervention studies, 2) it includes lower limbs motor impairments-induced mobility limitations items, 3) is significantly correlated with key impairments variables such as standing balance and walking speed, 4) and is a candidate for outcome measurement in foreseeable clinical trials. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia) It showed evidence of adequate content validity and excellent construct validity and internal consistency in ARSACS and we recently validated the French version.
次要结局
- Physical activities(64 weeks)
- Weight(64 weeks)
- Walking speed.(64 weeks)
- Medication change(64 weeks)
- Sitting balance(64 weeks)
- Life habits(64 weeks)
- RNA(64 weeks)
- Ataxia impact scale(64 weeks)
- height(64 weeks)
- Balance confidence(64 weeks)
- Muscle tone(64 weeks)
- Plasma(64 weeks)
- Mobility Life-space(64 weeks)
- Lower limb coordination(64 weeks)
- Fatigue(64 weeks)
- Anxiety and Depression(64 weeks)
- Functional lower extremity strength(64 weeks)
- Focus group with intervention group participants(1 day)
- CBA analyses and Willingness to pay(64 weeks)
- Standing balance(64 weeks)
- Activities of Daily Living(64 weeks)
- DNA(64 weeks)
- Urine(64 weeks)
- Saliva(64 weeks)
- Peak respiratory flow and cough(64 weeks)
- Falls.(64 weeks)
- Patient-reported impression of change.(64 weeks)
- Community mobility(7 consecutives days, 2 times)
- Serum(64 weeks)
- Pain characteristics(64 weeks)
- Focus groups with stakeholders(12 weeks)
- Quality of life(64 weeks)
- Gait's temporal parameters(64 weeks)
- Postural balance(64 weeks)
- Lower limb muscle activation(64 weeks)
- Stance balance(64 weeks)
研究者
Elise Duchesne
Full Professor
Laval University