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Clinical Trials in France / NCT06262269
Recruiting Not applicable

Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents

NCT06262269 · tracked via the Priya Life Science France tracker
Sponsor
Association des Paralysees de France (APF)
Phase
Not applicable
Started
2022-09-21
Last updated
2025-10-03

Condition(s) studied

Adolescent Idiopathic Scoliosis

Investigational drug(s) / intervention(s)

Home-based adapted physical activity program supervised by an APA teacher via individual video conference.First period of the home-based adapted physical activity program with an exercise booklet.Second period of the home-based adapted physical activity program with an exercise booklet.

Home-based adapted physical activity program supervised by an APA teacher via individual video conference.: Participants will follow a 12-week tele-rehabilitation programme involving high-intensity interval training (HIIT) adapted to their AIS. The programme includes three 45-minute individual sessions per week. The exercises are selected from a database designed for AIS patients. The APA teacher will systematically document the patient's presence or absence at each tele-rehabilitation session, thus assessing their adherence to the programme.

First period of the home-based adapted physical activity program with an exercise booklet.: Participants will receive a self-programme in the form of a booklet of specific HIIT-type exercises adapted to their AIS. The programme is to be carried out at home over a 12-week period, with 3 45-minute sessions per week. The exercises are taken from the same database. Each participant in the CONTROL group will be encouraged to keep a follow-up diary, noting the date, start time and end time of each session (in order to assess adherence to the sessions).

Second period of the home-based adapted physical activity program with an exercise booklet.: Participants will receive a self-programme in the form of a booklet containing specific HIIT-type exercises adapted to their AIS. The programme is to be carried out at home over a 12-week period, with 3 45-minute sessions per week. The exercises are taken from the same database. Each participant in the CONTROL group will be encouraged to keep a follow-up diary, noting the date, start time and end time of each session (in order to assess adherence to the sessions).

Study summary

This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows:

* Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS.
* A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis.

Eligibility

Sex
FEMALE
Min age
13 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Affiliated to a social security system * Having signed the consent after clear and fair information adapted to her age * Obtained signed consent from at least 1 of the 2 parents or holders of parental authority, after clear and fair information * Subject presenting an AIS defined by the existence of a three-dimensional deformity three-dimensional deformity of the spine associating a frontal deviation measured by by the frontal radiographic angle of Cobb which must be at least 15°, but less than 40°, and a vertebral rotation attested by the presence of a presence of at least 5° of gibbosity on Bunnel's scoliometer. * Subject with front and side radiographs of the total spine, according to the EOS EOS technique, under load, less than 3 months old * Risser test \< 4/5 (EOS radiographs less than 3 months old) * Subject not practicing any regular extracurricular physical activity (including regular (regular = at least 1 hour per week), for at least 6 months. * Internet connection at home allowing tele-rehabilitation in a dedicated a dedicated room for the time of the session with a free surface of minimum 4m² on the floor, without any obstacle up to the ceiling. * Compatibility with the technical requirements: access to a screen screen (computer or laptop, tablet...), with a minimum size of 8 inches (diagonal of 8 inches (diagonal of 20 cm), with an integrated or connected HD webcam connected, and a good quality sound, screen placed on a stable surface surface with a minimum height of 75cm and enough distance to see the to perceive from the camera the whole working area (4m²). Exclusion Criteria: (One criterion is sufficient for non-inclusion) * Subject with secondary scoliosis: neurological, orthopedic, malformative... * Placement of a corset or rehabilitation for less than 3 months * BMI ≤15 or ≥ 30 * Partial or total medical contraindication of any kind to the sports practice (examples: heart disease, unbalanced diabetes, juvenile polyarthritis, chronic painful joint pathology limiting physical performance, osteochondrosis of growth type Osgood-Schlater, Sever, Sinding-Larsen, osteochondritis, surgical sequelae limiting physical performance...) * Inability to undergo the medical follow-up of the trial for psychological social or geographical reasons.

Primary outcome measure(s)

  • Evaluation to overall physical performance on an ergometer-rowing machine — Measured at the baseline and after 12 weeks
    Measurement of the time taken to complete 2000m as quickly as possible (in seconds)

Trial sites (1)

FacilityCityRegionStatus
SMR Marc Sautelet Villeneuve-d'Ascq France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06262269 on ClinicalTrials.gov ↗ ← All trials in France