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

Adolescent Idiopathic Scoliosis Clinical Trial

— RCT-RPG  

Official title:

Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04568759
• Other study ID #: 2021-3065_RCT-RPG
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: St. Justine's Hospital
• Contact: Carole Fortin, PhD
• Phone: 514 343 6111
• Email: carole.fortin[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: April 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval	Québec

Sponsors (5)

Lead Sponsor	Collaborator
St. Justine's Hospital	CHU de Québec, Laval University, Shriners Hospitals for Children, Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cobb angle of at least 5 degrees	Angle measured on radiograph for scoliosis progression	6, 12 and 24 months
Secondary	Back pain on the Numerical Pain Rating Scale	Intensity of back pain on the Numerical Pain Rating Scale (0-10, where 0 indicates no pain et 10 the worst imaginable pain)	6, 12 and 24 months
Secondary	Italian Spine Youth Quality of Life questionnaire	Quality of life: score is between 0 and 100, where 100 represents a higher quality of life	6, 12 and 24 months
Secondary	Trunk imbalance	The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm	6 and 12 months
Secondary	Diaphragm excursion	Diaphragm excursion using ultrasound imaging in mm	6 and 12 months
Secondary	Forced vital capacity	Measured of respiratory function using a conventional spirometer	6 and 12 months
Secondary	Inter muscular coherence	Measure of the association between right and left paraspinal muscle activity at each frequency on a scale from 0 to 1, where 0 indicates independent processes and 1 indicates correlated processes.	6 and 12 months