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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age13-17
SponsorAssociation des Paralysees de France (APF)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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...)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

    Other intervention

    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.

    Other intervention

    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).

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: TELE-APAExperimental treatment 2 interventions
Group B: CONTROLActive comparator 2 interventions

Trial outcomes

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)

Time frame
Measured at the baseline and after 12 weeks

Secondary outcomes

1

Evaluation of overall physical performance on an ergometer-rowing machine

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

Time frame
Measured at 12 weeks and after 24 weeks
2

Evaluation of perivertebral muscle performance (Plank)

Maintaining maximum posture in seconds (s) in the Endurance plank test and two-side plank test.

Time frame
Measured at the baseline, after 12 weeks, and then after 24 weeks
3

Evaluation of perivertebral muscle performance (Rowing)

Evaluation of maximum strength in kilograms (kg) in the Pull-down and seated row cable.

Time frame
Measured at the baseline, after 12 weeks, and then after 24 weeks
4

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

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

Other outcomes

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