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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262269
• Other study ID #: Sportscol
• Secondary ID: 2022-A00021-42
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Association des Paralysees de France (APF)
• Contact: Guyomard Alice
• Phone: +330614399542
• Email: alice.guyomard[@]marcsautelet.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	SSR Marc Sautelet	Villeneuve-d'Ascq

Sponsors (2)

Lead Sponsor	Collaborator
Association des Paralysees de France (APF)	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of overall physical performance on an ergometer-rowing machine	Measurement of the time taken to complete 2000m as quickly as possible (in seconds)	Measured at 12 weeks and after 24 weeks
Secondary	Evaluation of perivertebral muscle performance (Plank)	Maintaining maximum posture in seconds (s) in the Endurance plank test and two-side plank test.	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Evaluation of perivertebral muscle performance (Rowing)	Evaluation of maximum strength in kilograms (kg) in the Pull-down and seated row cable.	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Indirect assessment of VO2 max	It will be evaluated from the Maximum Aerobic Speed (MAS), during the VAMEVAL test of Cazorla and Light on treadmill	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	The Ratings Perceveid Exertion for Children during exercise (RPE-C)	It will be carried out during the indirect evaluation of VO2 max, during the treadmill test, using the Borg scale adapted to treadmill test, using the Ratings Perceveid Exertion for Children (RPE-C). It is a pictorial, vertical scale graduated from 6 (low perception of effort) to 20 (maximum perception of effort). This evaluation will be requested every minute: the subject must indicate to the examiner (orally or by pointing) the score on the scale.	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Assessment of motivation to change	It will be assessed by the questionnaire URICA (University of Rhode Island Change Assessment), composed of 32 statements, validated in children. The questionnaire allows us to determine in which stage the person is in his or her The URICA questionnaire makes it possible to determine in which stage the person is in his or her change: "Pre-contemplation", "Contemplation", "Determination", "Action".	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Evaluation of attendance at adapted physical activity sessions	It will be done by counting the number of physical activity sessions performed, either by the follow-up booklet (Control group for Control for Period 1, the 2 groups for Period 2), or by the count made by the the count made by the APA teacher who notes the presence of each patient each patient during the tele-rehabilitation sessions for the group TELE-APA group during Period 1.	Once a week, up to 24 weeks
Secondary	Anthropometric evaluation (Height)	Measurement of height in meters (m).	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Anthropometric evaluation (weight)	Measurement of weight in kilograms (kg).	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Anthropometric evaluation (BMI)	Weight and height will be combined to report BMI in kg/m^2)	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Anthropometric evaluation by bioimpedance measurement	Measurement of Lean Mass in kilograms (kg), Muscle Mass in kilograms (kg) and Fat Mass in kilograms (kg).	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Analysis of the static vertical posture on a force platform SATEL®	The evaluation allows the analysis of the trajectory of the center of pressure, direct consequence of the body oscillations in standing position. The examination is carried out according to 3 modalities (eyes open on hard ground, eyes closed on closed on a hard floor, open eyes on a soft floor) allowing to obtain information on each sensory modality necessary for postural stabilization (visual, vestibular, and somesthesic related to the sole of the foot).	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Evaluation of the EOS radiograph of the total spine in front (Type)	Evaluation of the type of scoliosis according to Lenke's classification. Radiographic measurements in degrees of the Cobb angles, of the main curvature, of the thoracic kyphosis (between T4 and T12 and between T1 and T12), lumbar lordosis (between L1 and S1 and between L1 and L5).	Measured at the baseline and then after 24 weeks
Secondary	Evaluation of the EOS radiograph of the total spine in front and in profile (Angle)	Radiographic measurements in degrees of the Cobb angles, of the main curvature, of the thoracic kyphosis (between T4 and T12 and between T1 and T12), lumbar lordosis (between L1 and S1 and between L1 and L5).	Measured at the baseline and then after 24 weeks
Secondary	Evaluation of the EOS radiograph of the total spine in front (Frontal deviation)	Measurement in millimeters of the frontal spine deviation.	Measured at the baseline and then after 24 weeks
Secondary	Evaluation of the EOS radiograph of the total spine in front (Risser)	Evaluation of the Risser bone maturity test.	Measured at the baseline and then after 24 weeks
Secondary	Photogrammetric morphostatic evaluation by surface topography	Photogrammetric measurements in degrees of the Cobb angles, of the main curvature, of the thoracic kyphosis (between T4 and T12 and between T1 and T12), lumbar lordosis (between L1 and S1 and between L1 and L5).; Measurement in millimeters of the frontal spine deviation.	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Measurement of the main gibbosity	The gibbosity will be evaluated during the clinical examination, in degrees, using Bunnel's scoliometer, during the Forward Bending Test.	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Assessment of quality of life by the Scoliosis Research Society (SRS) scale : SRS-18	It is a specific scale for scoliosis, composed of 18 questions questions, classified into 5 themes (pain, function, body image, general satisfaction image, general satisfaction, treatment satisfaction). The global score score is between 18 (poor quality of life) and 90 (good quality of life). quality of life).	Measured at the baseline, after 12 weeks, and then after 24 weeks
Secondary	Satisfaction questionnaires	Satisfaction questionnaire at V2: the adapted physical activity teachers who supervised the tele-rehabilitation sessions, all the patients and a responsible representative fill in a satisfaction questionnaire at V2. A Visual Analogue Scale rated from 0 to 5 is used to assess the level of satisfaction with the treatment between V1 and V2 (Pleasure during the session, content of the sessions, safety of the sessions).; - Additional question at V3: carried out only for the TELE-APA group. This is a double response question to define which adapted physical activity modality the patient preferred: tele-rehabilitation or self-programmed exercise book.	Measured at the baseline, after 12 weeks, and then after 24 weeks