NCT06262269

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Association des Paralysees de France (APF) · Academic / Other
• Sex: Female
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

AIS is a deformity affecting 2% of adolescents between the ages of 10 and 16. It is a potentially severe condition with repercussions that impair the quality of life. Complications include respiratory issues (chronic restrictive insufficiency), pain and functional problems (chronic pain, evolving deformities even after growth cessation), bone-related concerns (osteopenia), psychological impacts (loss of self-esteem, tendency towards anxiety and depression), postural alterations (orthostatic postural control impairment), and aesthetic issues (deterioration of self-image). The etiopathogenesis of AIS is not fully understood. Conventional treatments typically involve a combination of rehabilitation sessions and the use of a brace. Occasionally, corrective surgery (arthrodesis) may be necessary. There is a broad scientific consensus emphasizing the significant role of regular physical and sports activities (PSA) in AIS, as they improve its various comorbidities and complications. Simultaneously, several epidemiological studies highlight insufficient engagement in PSA among adolescents, especially in France. This deficiency is more pronounced among girls, who are also eight times more affected by AIS than boys. Various factors contribute to adolescents' lack of interest in PSA, including excessive screen time, limited (geographical or economic) access to sports facilities, and a shortage of time and motivation. Medical follow-up consultations for patients with AIS present an opportunity to underscore the importance of regularly engaging in PSA. It is also emphasized that these activities can be performed at home through specific self-programmed routines (adapted exercise booklets) provided to patients. Since the March 2020 covid-related lockdown, the investigators have observed that patients are making little use of the exercise books provided as part of their medical monitoring and are increasingly turning to online sports applications. This is an advantage as it allows adolescents to combine screen activities with PSA. However, drawbacks include the non-specificity of the exercises offered, which may not always be suitable for AIS, and the lack of consistency over time, potential sources of inefficiency. Therefore, the aim to facilitate access to tailored PSA in a population of adolescents with AIS. Various studies suggest that tele-rehabilitation is a credible therapeutic alternative applicable in key areas of pediatric rehabilitation. High-Intensity Interval Training (HIIT) programs, a method of PSA involving intervals of high intensity, are effective, particularly suitable for adolescents, and feasible through tele-rehabilitation. The hypothesis is that an intervention involving a HIIT training program through tele-rehabilitation, supervised by an Adapted Physical Activity (APA) teacher, is effective in AIS. To test this hypothesis, the investigators propose to compare the effectiveness of PSA at home over 12 weeks (PERIOD 1) in two groups of adolescents with AIS: a test group or TELE-APA group, which will receive an individualized, specific HIIT program tailored to each patient's scoliosis through tele-rehabilitation, supervised by an APA teacher, and a CONTROL group, which will receive a PSA program at home based on specific exercise booklets, of the HIIT type, adapted to each patient's scoliosis. After the third month, both groups will be followed for an additional 12 weeks (PERIOD 2), during which they will receive only a PSA program at home, in the form of an exercise booklet, of the HIIT type, adapted to each patient's scoliosis.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
OTHER	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.
OTHER	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).
OTHER	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).

Timeline

• Start date: 2022-09-21
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-02-16
• Last updated: 2025-10-03

Locations

1 site across 1 country: France