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Clinical Trials/NCT04568759
NCT04568759
Active, Not Recruiting
N/A

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

St. Justine's Hospital2 sites in 1 country47 target enrollmentAugust 15, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adolescent Idiopathic Scoliosis
Sponsor
St. Justine's Hospital
Enrollment
47
Locations
2
Primary Endpoint
Change in Cobb angle of at least 5 degrees
Status
Active, Not Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2021
End Date
September 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Carole Fortin

Associate professor

St. Justine's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Cobb angle of at least 5 degrees

Time Frame: 6, 12 and 24 months

Angle measured on radiograph for scoliosis progression

Secondary Outcomes

  • 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 Sites (2)

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