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

NCT06262269 | Recruiting

• 2 other identifiers: Sportscol2022-A00021-42
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adapted physical activity; Telerehabilitation; Physical condition; Hiit; Exercise booklet

Outcome Measures

Primary Outcomes (1)

• Evaluation to overall physical performance on an ergometer-rowing machine

  Measurement of the time taken to complete 2000m as quickly as possible (in seconds)

  Measured at the baseline and after 12 weeks

Secondary Outcomes (20)

• Evaluation of overall physical performance on an ergometer-rowing machine

  Measured at 12 weeks and after 24 weeks

• Evaluation of perivertebral muscle performance (Plank)

  Measured at the baseline, after 12 weeks, and then after 24 weeks

• Evaluation of perivertebral muscle performance (Rowing)

  Measured at the baseline, after 12 weeks, and then after 24 weeks

• Indirect assessment of VO2 max

  Measured at the baseline, after 12 weeks, and then after 24 weeks

• The Ratings Perceveid Exertion for Children during exercise (RPE-C)

  Measured at the baseline, after 12 weeks, and then after 24 weeks

Study Arms (2)

TELE-APA

EXPERIMENTAL

The TELE-APA group will benefit from an individual, specific HIIT type program, adapted to the scoliosis of each patient, by tele-rehabilitation, supervised by a teacher in adapted physical activities during 12 weeks. Then he will benefit from an adapted physical activity program at home, based on a booklet of specific exercises identical to that of the CONTROL group, of HIIT type, adapted to the scoliosis of adapted to the scoliosis of each patient for 12 weeks.

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

CONTROL

ACTIVE COMPARATOR

The CONTROL group will benefit from an adapted physical activity program at home, based on a booklet of specific HIIT-type exercises, adapted to the scoliosis of each patient for 2 times 12 weeks. A new exercise booklet is given at the end of the first 12 weeks.

Other: First period of the home-based adapted physical activity program with an exercise booklet.; Other: Second period of the home-based adapted physical activity program with an exercise booklet.

Interventions

Home-based adapted physical activity program supervised by an APA teacher via individual video conference. OTHER

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.

Also known as: Period 1 - TELE-APA

TELE-APA

First period of the home-based adapted physical activity program with an exercise booklet. OTHER

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).

Also known as: Period 1 - Booklet

CONTROL

Second period of the home-based adapted physical activity program with an exercise booklet. OTHER

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).

Also known as: Period 2

CONTROL; TELE-APA

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association des Paralysees de France (APF): lead
• Fondation de France: collaborator

Study Sites (1)

SMR Marc Sautelet

Villeneuve-d'Ascq, 59650, France

RECRUITING

Study Officials

• Jean-François Catanzariti, Dr.

  Association des Paralysés de France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guyomard Alice

CONTACT

+330614399542; alice.guyomard@marcsautelet.fr

Brouillard Anthony, Phd.

CONTACT

anthony.brouillard@marcsautelet.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 16, 2024
• Study Start: September 21, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)