Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262269
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-02-01
Brief Title:
Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents
Sponsor:
Association des Paralysees de France APF
Organization:
Association des Paralysees de France APF
Study Overview
Official Title:
Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Application to Idiopathic Scoliosis in Adolescents
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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 patients 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 patients scoliosis
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 patients 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 patients 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 patients scoliosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A00021-42 | OTHER | Number IDRCB | None |