Clinical trial NCT05595941: Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae
Official title: Effectiveness of Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae : a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Sequelae
Lead sponsor: Hopital La Musse
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind pilot randomised controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Berg balance scale
timeFrame: Pre-treatment
measure: Berg balance scale
timeFrame: Pre-treatment : at three months
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: Pre-treatment
measure: Timed Up and Go Test
timeFrame: Pre-treatment : at three months
measure: Five Times Sit to Stand
timeFrame: Pre-treatment
measure: Five Times Sit to Stand
timeFrame: Pre-treatment : at three months
measure: Activities-specific Balance Confidence Scale - Simplified
timeFrame: Pre-treatment
measure: Activities-specific Balance Confidence Scale - Simplified
timeFrame: Pre-treatment : at three months
measure: State-Trait Anxiety Inventory
timeFrame: Pre-treatment
measure: State-Trait Anxiety Inventory
timeFrame: Pre-treatment : at three months
measure: Beck Depression Inventory
timeFrame: Pre-treatment
measure: Beck Depression Inventory
timeFrame: Pre-treatment : at three months
measure: Reintegration to Normal Living Index
timeFrame: Pre-treatment
measure: Reintegration to Normal Living Index
timeFrame: Pre-treatment : at three months
Other outcomes:
Locations:
city: Saint-Sébastien-de-Morsent
country: France
facility: Hôpital La Musse
state: Normandie
Study officials:
affiliation: Hôpital La Musse
name: Charlotte Menez, PhD
role: PRINCIPAL_INVESTIGATOR
References: