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

Not Applicable

Active, not recruiting

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Other: Global postural re-education

• Registration Number: NCT04568759
• Lead Sponsor: St. Justine's Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Study Start: 2021-08-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-03-01
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care group	Global postural re-education	Observation or brace plus conventional physiotherapy exercises on video
GPR group	Global postural re-education	GPR interventions added to standard care (observation or brace)

Primary Outcome Measures

Name	Time	Method
Change in Cobb angle of at least 5 degrees	6, 12 and 24 months	Angle measured on radiograph for scoliosis progression

Secondary Outcome Measures

Name	Time	Method
Back pain on the Numerical Pain Rating Scale	6, 12 and 24 months	Intensity of back pain on the Numerical Pain Rating Scale (0-10, where 0 indicates no pain et 10 the worst imaginable pain)
Italian Spine Youth Quality of Life questionnaire	6, 12 and 24 months	Quality of life: score is between 0 and 100, where 100 represents a higher quality of life
Trunk imbalance	6 and 12 months	The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm
Diaphragm excursion	6 and 12 months	Diaphragm excursion using ultrasound imaging in mm

Trial Locations

Locations (2)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada

Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval; 🇨🇦 Québec, Canada