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Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

NCT ID: NCT04568759

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2026-09-30

Brief Summary

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The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.

Detailed Description

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Conditions

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Adolescent Idiopathic Scoliosis

Keywords

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adolescent idiopathic scoliosis Global postural re-education back pain quality of life trunk imbalance inter muscular coherence respiratory function functional performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard care group

Observation or brace plus conventional physiotherapy exercises on video

Group Type ACTIVE_COMPARATOR

Global postural re-education

Intervention Type OTHER

GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities

GPR group

GPR interventions added to standard care (observation or brace)

Group Type EXPERIMENTAL

Global postural re-education

Intervention Type OTHER

GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities

Interventions

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Global postural re-education

GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* aged between 10 and 16 years old,
* Cobb angle between 15º and 45º,
* Risser sign ≤3 (skeletal growth incomplete),
* with a risk of progression index \> 1.3,
* having recent x-rays (4-6 weeks),
* ability to travel weekly to attend GPR intervention

Exclusion Criteria

* patients with diagnosis other than AIS,
* patients who are planned for surgery,
* have had surgery,
* worn a brace for at least three months prior to GPR intervention
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role collaborator

Shriners Hospitals for Children

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role collaborator

CHU de Québec

UNKNOWN

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carole Fortin

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carole Fortin, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Sainte-Justine/Université de Montréal

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status

Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval

Québec, , Canada

Site Status

Countries

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Canada

Other Identifiers

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2021-3065_RCT-RPG

Identifier Type: -

Identifier Source: org_study_id