Effectiveness of Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae : a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Berg balance scale
研究概览
简要总结
Stroke is a major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. That why the investigators need to explore options for long-term sustainable interventions that which takes into account the patient as a whole. In particular, regular physical activity is recommended, but it must be adaptable to the patient's impairments. Teaching yoga may be an interesting option. Indeed, yoga is a mind-body practice which become increasingly widespread in the world. Recent studies highlight positive effect of yoga for this population. However, accessibility to yoga classes can be limited by many factors: lack of transportation, lack of available health professionals, confinement requirements... Therefore, it seems relevant to evaluate the effectiveness of yoga delivered through tele-rehabilitation.
The main objective of this study is to evaluate the effectiveness of a tele-yoga program adapted to stroke survivors to improve their functional balance.
The secondary objectives are to evaluate the effectiveness of the adapted tele-yoga program in improving functional mobility, anxiety, depression and reintegration into normal life.
详细描述
The investigators will conduct a single-blind randomised controlled trial to study the effectiveness of a tele-yoga programme compared to an inactive control group in improving balance in chronic post-stroke subjects. The primary hypothesis is that yoga is effective in improving balance in chronic post-stroke patients. The secondary hypothesis is that yoga is effective in improving functional mobility, anxiety, depression, and reintegration into normal life.
The experiment will take place in metropolitan France, and the whole experimental procedure (recruitment, evaluation, experimentation) will take place at a distance, via information and communication technologies. The statistical power study indicates that 15 patients per group would be required. Subjects will be randomly assigned to one of the following groupe: the TELEYOG'AVC programme or the inactive control group. The TELEYOG'AVC programme will involve yoga sessions with postural, respiratory, and meditative work delivered by videoconference. This programme includes two 60-minute group sessions per week, for 12 weeks, plus one weekly home-based session (with video support). The control group will be instructed not to change their habits during the 12 weeks of experimentation, then after the final assessment (T1) they will be able to benefit from the TELEYOG'AVC programme if they want. Patients will be assessed before the experiment (T0) and after the 12-week experiment (T1). The assessments will be carried out blind, using a protocol built around the International Classification of Functioning and Disability (ICF). The main criterion is balance, assessed by the Berg balance scale (0-56 point scale). The secondary outcomes will be assessed by: Timed Up and Go Test (timed task in seconds), 5 time-sit-to-stand (timed task in seconds), the activities-specific Balance Confidence Scale - Simplified (questionnaire in %), State-Trait Anxiety Inventory (2 questionnaires out of 80), Beck Depression Inventory (score out of 63), Reintegration to Normal Living Index (score out of 22). Adherence to the programme will be assessed between T0 and T1 by the number of group and individual sessions completed.
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
- Single (Outcomes Assessor)
盲法说明
The evaluator will not have access to participants' allocations, will never attend tele-yoga sessions, and patients will be told never to reveal their allocations to the evaluator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have had a stroke more than 6 months ago ;
- •to have moderate balance problems (objectivity by a score between 41 and 51 on the Berg balance scale);
- •to be able to stand and walk at least 10 meters, with or without technical assistance;
- •to be able to get down and up from the floor independently,
- •to have a caregiver present during the assessments, and designated as the "contact person" in case of problems during the tele-yoga sessions,
- •to be equipped with a good quality internet connection and a computer tool allowing the use of Zoom software,
- •and to be affiliated to a social security system.
排除标准
- •be under 18 years of age;
- •to suffer from cognitive disorders (score lower than 4 points on the 6-items Mini-Mental State Examination) preventing the comprehension of the instructions or to give his informed consent;
- •to have a history of otolaryngological pathologies causing recurrent vertiginous syndromes;
- •not being fluent in French (to the point of not being able to answer the questionnaires or understand the instructions);
- •have a medical contraindication to physical activity;
- •current and regular participation in another physical activity program;
- •persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care, as well as adults under legal protection (guardianship, curatorship and safeguard of justice), pregnant women, women in labour and breastfeeding women, referred to in articles L.1121-5 to 8 of the french public health code.
结局指标
主要结局
Berg balance scale
时间窗: Pre-treatment : at three months
This test quantitatively assesses balance in adults. In this 14-item scale, patients are asked to maintain positions and perform movement tasks of varying difficulty. Patients are given a score between 0 and 4 on their ability to respond to dimensions of balance. An overall score can be calculated from a total of 56. The higher the score, the better the balance.
次要结局
- Beck Depression Inventory(Pre-treatment : at three months)
- Timed Up and Go Test(Pre-treatment : at three months)
- Five Times Sit to Stand(Pre-treatment : at three months)
- Activities-specific Balance Confidence Scale - Simplified(Pre-treatment : at three months)
- State-Trait Anxiety Inventory(Pre-treatment : at three months)
- Reintegration to Normal Living Index(Pre-treatment : at three months)