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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Other: Global postural re-education

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1M 2S8
    • Recruiting
    • Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care group; Observation or brace plus conventional physiotherapy exercises on video	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
Experimental: GPR group; GPR interventions added to standard care (observation or brace)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cobb angle of at least 5 degrees	Angle measured on radiograph for scoliosis progression	6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Trunk imbalance	The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm	6 and 12 months
Diaphragm excursion	Diaphragm excursion using ultrasound imaging in mm	6 and 12 months
Forced vital capacity	Measured of respiratory function using a conventional spirometer	6 and 12 months
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

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: Shriners Hospitals for Children; Laval University; Université de Montréal; CHU de Québec

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; back pain; functional performance; adolescent idiopathic scoliosis; respiratory function; Global postural re-education; trunk imbalance; inter muscular coherence
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2021-3065_RCT-RPG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No