Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae

NCT05595941 | Terminated

• 1 other identifier: 2022-A00929-34
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (2)

• Berg balance scale

  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.

  Pre-treatment

• Berg balance scale

  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.

  Pre-treatment : at three months

Secondary Outcomes (12)

• Timed Up and Go Test

  Pre-treatment

• Timed Up and Go Test

  Pre-treatment : at three months

• Five Times Sit to Stand

  Pre-treatment

• Five Times Sit to Stand

  Pre-treatment : at three months

• Activities-specific Balance Confidence Scale - Simplified

  Pre-treatment

Study Arms (2)

TELEYOG'AVC Group

EXPERIMENTAL

The subjects of the experimental group will be invited to participate in 60-minute tele-yoga sessions, twice a week, for 12 weeks. The sessions will take place via the Zoom videoconference software, in small groups (maximum 5 people) in order to adapt the practice to the possibilities of each subject. In addition, an additional weekly session, independently at home, will be recommended to participants, accompanied by a pre-recorded video support hosted on YouTube.

Other: tele-yoga

Wainting list Group

NO INTERVENTION

The subjects in the control group will be asked not to change their habits during the entire experimental phase (T0-T1). They will be able to benefit in turn from the tele-yoga program (free of charge), if they wish, once the evaluations in T1 are completed.

Interventions

tele-yoga OTHER

Each session will include postural exercises (asanas), standing, sitting and lying down, in order to work on balance, muscular strength and endurance, as well as flexibility. They will be adapted to the physical possibilities of the patients with the help of accessories such as chairs, straps, cushions, blocks (provided free to each participant). In addition, breathing work will accompany these postures. A relaxing passive meditation is practiced at the end of each session, in a lying posture called "Savasana". The complexity of the postures, their holding time, or the number of repetitions will increase as the program progresses, relative to the abilities of each participant.

TELEYOG'AVC Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital La Musse: lead

Study Sites (1)

Hôpital La Musse

Saint-Sébastien-de-Morsent, Normandy, 27180, France

Location

Study Officials

• Charlotte Menez, PhD

  Hôpital La Musse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-blind pilot randomised controlled trial.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 27, 2022
• Study Start: October 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)