Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent (RCT-RPG)
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Global postural re-education
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring adolescent idiopathic scoliosis, Global postural re-education, back pain, quality of life, trunk imbalance, inter muscular coherence, respiratory function, functional performance
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
Sites / Locations
- CHU Sainte-JustineRecruiting
- Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université LavalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care group
GPR group
Arm Description
Observation or brace plus conventional physiotherapy exercises on video
GPR interventions added to standard care (observation or brace)
Outcomes
Primary Outcome Measures
Change in Cobb angle of at least 5 degrees
Angle measured on radiograph for scoliosis progression
Secondary Outcome Measures
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)
Italian Spine Youth Quality of Life questionnaire
Quality of life: score is between 0 and 100, where 100 represents a higher quality of life
Trunk imbalance
The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm
Diaphragm excursion
Diaphragm excursion using ultrasound imaging in mm
Forced vital capacity
Measured of respiratory function using a conventional spirometer
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.
Full Information
NCT ID
NCT04568759
First Posted
September 23, 2020
Last Updated
April 11, 2023
Sponsor
St. Justine's Hospital
Collaborators
Laval University, Shriners Hospitals for Children, Université de Montréal, CHU de Québec
1. Study Identification
Unique Protocol Identification Number
NCT04568759
Brief Title
Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
Laval University, Shriners Hospitals for Children, Université de Montréal, CHU de Québec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
Observation or brace plus conventional physiotherapy exercises on video
Arm Title
GPR group
Arm Type
Experimental
Arm Description
GPR interventions added to standard care (observation or brace)
Intervention Type
Other
Intervention Name(s)
Global postural re-education
Intervention Description
GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities
Primary Outcome Measure Information:
Title
Change in Cobb angle of at least 5 degrees
Description
Angle measured on radiograph for scoliosis progression
Time Frame
6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Back pain on the Numerical Pain Rating Scale
Description
Intensity of back pain on the Numerical Pain Rating Scale (0-10, where 0 indicates no pain et 10 the worst imaginable pain)
Time Frame
6, 12 and 24 months
Title
Italian Spine Youth Quality of Life questionnaire
Description
Quality of life: score is between 0 and 100, where 100 represents a higher quality of life
Time Frame
6, 12 and 24 months
Title
Trunk imbalance
Description
The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm
Time Frame
6 and 12 months
Title
Diaphragm excursion
Description
Diaphragm excursion using ultrasound imaging in mm
Time Frame
6 and 12 months
Title
Forced vital capacity
Description
Measured of respiratory function using a conventional spirometer
Time Frame
6 and 12 months
Title
Inter muscular coherence
Description
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.
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carole Fortin, PhD
Phone
514 343 6111
Ext
17262
Email
carole.fortin@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Soraya Barchi, MSc
Phone
514 345 4931
Ext
4352
Email
soraya.barchi.hsj@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Fortin, PhD
Organizational Affiliation
CHU Sainte-Justine/Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Fortin, Ph.D.
Phone
514 343 6111
Ext
17262
Email
carole.fortin@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Soraya Barchi, M.Sc.
Phone
514 345 4931
Ext
4352
Email
soraya.barchi.hsj@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Carole Fortin, Ph.D.
First Name & Middle Initial & Last Name & Degree
Stefan Parent, Ph.D.
Facility Name
Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval
City
Québec
ZIP/Postal Code
G1M 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Sébastien Roy, Ph.D.
Phone
418 649 3735
Ext
6005
Email
jean-sebastien.roy@fmed.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Martin Simoneau, Ph.D.
Phone
418 745 2129
Email
martin.simoneau@kin.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Jean-Sébastien Roy, Ph.D.
First Name & Middle Initial & Last Name & Degree
Martin Simoneau, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
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Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
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