Clinical trial NCT06262269: Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents
Official title: Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Application to Idiopathic Scoliosis in Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adapted physical activity
Telerehabilitation
Physical condition
Hiit
Exercise booklet
Lead sponsor: Association des Paralysees de France (APF)
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2024-02-16
Enrollment: 70
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 outcomes:
measure: Evaluation to overall physical performance on an ergometer-rowing machine
timeFrame: Measured at the baseline and after 12 weeks
Secondary outcomes:
measure: Evaluation of overall physical performance on an ergometer-rowing machine
timeFrame: Measured at 12 weeks and after 24 weeks
measure: Evaluation of perivertebral muscle performance (Plank)
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Evaluation of perivertebral muscle performance (Rowing)
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Indirect assessment of VO2 max
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: The Ratings Perceveid Exertion for Children during exercise (RPE-C)
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Assessment of motivation to change
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Evaluation of attendance at adapted physical activity sessions
timeFrame: Once a week, up to 24 weeks
measure: Anthropometric evaluation (Height)
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Anthropometric evaluation (weight)
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Anthropometric evaluation (BMI)
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Anthropometric evaluation by bioimpedance measurement
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Analysis of the static vertical posture on a force platform SATEL®
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Evaluation of the EOS radiograph of the total spine in front (Type)
timeFrame: Measured at the baseline and then after 24 weeks
measure: Evaluation of the EOS radiograph of the total spine in front and in profile (Angle)
timeFrame: Measured at the baseline and then after 24 weeks
measure: Evaluation of the EOS radiograph of the total spine in front (Frontal deviation)
timeFrame: Measured at the baseline and then after 24 weeks
measure: Evaluation of the EOS radiograph of the total spine in front (Risser)
timeFrame: Measured at the baseline and then after 24 weeks
measure: Photogrammetric morphostatic evaluation by surface topography
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Measurement of the main gibbosity
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Assessment of quality of life by the Scoliosis Research Society (SRS) scale : SRS-18
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
measure: Satisfaction questionnaires
timeFrame: Measured at the baseline, after 12 weeks, and then after 24 weeks
Other outcomes:
Locations:
city: Villeneuve-d'Ascq
country: France
facility: SSR Marc Sautelet
Study officials:
affiliation: Association des Paralysés de France
name: Jean-François Catanzariti, Dr.
role: PRINCIPAL_INVESTIGATOR
References: