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

NCT04568759 | Active Not Recruiting DMC

• 1 other identifier: 2021-3065_RCT-RPG
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Cobb angle of at least 5 degrees

  Angle measured on radiograph for scoliosis progression

  6, 12 and 24 months

Secondary Outcomes (4)

• Back pain on the Numerical Pain Rating Scale

  6, 12 and 24 months

• Italian Spine Youth Quality of Life questionnaire

  6, 12 and 24 months

• Trunk imbalance

  6 and 12 months

• Diaphragm excursion

  6 and 12 months

Study Arms (2)

Standard care group

ACTIVE COMPARATOR

Observation or brace plus conventional physiotherapy exercises on video

Other: Global postural re-education

GPR group

EXPERIMENTAL

GPR interventions added to standard care (observation or brace)

Other: Global postural re-education

Interventions

Global postural re-education OTHER

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

GPR group; Standard care group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Laval University: collaborator
• Shriners Hospitals for Children: collaborator
• Université de Montréal: collaborator
• CHU de Québec: collaborator

Study Sites (2)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

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

Québec, G1M 2S8, Canada

Location

MeSH Terms

Conditions

Back Pain; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Carole Fortin, PhD

  CHU Sainte-Justine/Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: August 15, 2021
• Primary Completion: March 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)