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

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ClinicalTrials.gov Identifier: NCT04568759
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : October 14, 2021
Sponsor:
Collaborators:
Laval University
Shriners Hospitals for Children
Université de Montréal
CHU de Québec
Information provided by (Responsible Party):
Carole Fortin, St. Justine's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Other: Global postural re-education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
Actual Study Start Date : August 15, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Cobb angle of at least 5 degrees [ Time Frame: 6, 12 and 24 months ]
    Angle measured on radiograph for scoliosis progression


Secondary Outcome Measures :
  1. Back pain on the Numerical Pain Rating Scale [ Time Frame: 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)

  2. Italian Spine Youth Quality of Life questionnaire [ Time Frame: 6, 12 and 24 months ]
    Quality of life: score is between 0 and 100, where 100 represents a higher quality of life

  3. Trunk imbalance [ Time Frame: 6 and 12 months ]
    The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm

  4. Diaphragm excursion [ Time Frame: 6 and 12 months ]
    Diaphragm excursion using ultrasound imaging in mm

  5. Forced vital capacity [ Time Frame: 6 and 12 months ]
    Measured of respiratory function using a conventional spirometer

  6. Inter muscular coherence [ Time Frame: 6 and 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568759


Contacts
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Contact: Carole Fortin, PhD 514 343 6111 ext 17262 carole.fortin@umontreal.ca
Contact: Soraya Barchi, MSc 514 345 4931 ext 4352 soraya.barchi.hsj@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Carole Fortin, Ph.D.    514 343 6111 ext 17262    carole.fortin@umontreal.ca   
Contact: Soraya Barchi, M.Sc.    514 345 4931 ext 4352    soraya.barchi.hsj@ssss.gouv.qc.ca   
Principal Investigator: Carole Fortin, Ph.D.         
Sub-Investigator: Stefan Parent, Ph.D.         
Canada
Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval Recruiting
Québec, Canada, G1M 2S8
Contact: Jean-Sébastien Roy, Ph.D.    418 649 3735 ext 6005    jean-sebastien.roy@fmed.ulaval.ca   
Contact: Martin Simoneau, Ph.D.    418 745 2129    martin.simoneau@kin.ulaval.ca   
Sub-Investigator: Jean-Sébastien Roy, Ph.D.         
Sub-Investigator: Martin Simoneau, Ph.D.         
Sponsors and Collaborators
St. Justine's Hospital
Laval University
Shriners Hospitals for Children
Université de Montréal
CHU de Québec
Investigators
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Principal Investigator: Carole Fortin, PhD CHU Sainte-Justine/Université de Montréal
More Information
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Responsible Party: Carole Fortin, Associate professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT04568759    
Other Study ID Numbers: 2021-3065_RCT-RPG
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carole Fortin, St. Justine's Hospital:
adolescent idiopathic scoliosis
Global postural re-education
back pain
quality of life
 trunk imbalance
inter muscular coherence
respiratory function
functional performance
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases