Effect of Global Postural Re-education in Idiopathic Scoliosis

Study Overview
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Brief Summary
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In North America, children and adolescents with idiopathic scoliosis (IS) are rarely referred for a rehabilitation program whereas the European guidelines stated that scientific evidences concerning scoliosis specific physiotherapy exercises were strong enough to recommend the use of these exercises at an early stage. The objectives of this pilot study is to assess feasibility of conducting a larger randomized control trial (RCT) on the effect of global postural re-education (GPR) on scoliosis progression (Cobb angle) and posture, back pain and participation and to assess the equivalence of two groups of GPR interventions. A convenience sample of 60 adolescents with IS (Cobb angle 15º-50º, Risser sign ≤3) will be recruited at CHU Sainte-Justine. Participants will be randomly allocated to GPR-A (individual sessions once a week) or GPR-B (individual sessions once per two weeks alternately with class exercises once per two weeks) for 6 months. After 6 months, groups will be interchanged for another 6 months. Feasibility outcomes will be recruitment rate, consent rate, completion rate and adherence to treatment at 12 months. The primary outcome of the effect of GPR will be the Cobb angle. Secondary outcomes will be: posture, back pain and participation at 6 and 12 months. Statistical analyses: For feasibility, percentage of eligible patients recruited, percentage of recruited patients who completed the trial and adherence to treatment will be calculated. For the preliminary effects of GPR, linear mixed-models will be used to assess differences in groups' changes from baseline, to 6 and 12-month while adjusting for covariates (age, Risser, adherence). Separate analyses will be conducted for each outcome.

Official Title
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Pilot Study for a Randomized Controlled Clinical Trial on the Effect of Global Postural Re-education in the Treatment of Idiopathic Scoliosis: a Feasibility Study

Conditions
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Idiopathic Scoliosis

Intervention / Treatment
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* Other: GPR-A
* Other: GPR-B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 8 and 16 years old, Cobb angle between 15º and 50º, a Risser sign ≤3 (skeletal growth incomplete), having recent x-rays (4-6 weeks), ability to travel weekly to attend GPR interventions Exclusion Criteria: patients who are planning surgery or have had surgery, previous regular physiotherapy or other conservative treatment (chiro, osteopathy), worn a brace for at least three months prior to GPR interventions, scheduled for clinic follow-up later than in 6±2 months, or to be discharged before 12 months.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GPR-A<br>The 6-months supervised GPR-A group will receive a 1-hour-long individual session once a week plus a home program (1 or 2 exercises, 2 times a week). | Other: GPR-A<br>* Standard Global postural re-education physiotherapy scoliosis specific exercises<br>|
| Experimental: GPR-B<br>The 6-months supervised GPR-B group will receive a 1-hour long individual session once per two weeks alternately with a 1-hour-long class of exercises once per two weeks plus a home program (1 or 2 exercises, 2 times a week). | Other: GPR-B<br>* Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cobb angle | Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posture: shoulder elevation | Clinical Photographic Postural Assessment Tool: The angle formed between a line drawn between the left and right coracoid process markers, and the horizontal: a decrease of this angle indicate improvement | 6 and 12 months | 
| Posture: right waist angle | Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the cent Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the center of the waist to the lower end of the waist on the right side: more symmetry with the left side indicate improvement | 6 and 12 months | 
| Posture: left waist angle | Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the cent Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end of the waist to the center of the waist, and from the center of the waist to the lower end of the waist on the left side: more symmetry with the right side indicate improvement | 6 and 12 months | 
| Posture: thoracic scoliosis | Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end-vertebra to the apex of the thoracic scoliosis curve and from the apex to the lower end-vertebra of the curve: decrease of this angle indicate improvement | 6 and 12 months | 
| Posture: lumbar scoliosis | Clinical Photographic Postural Assessment Tool: The angle formed by lines drawn from the upper end-vertebra to the apex of the thoracolumbar or lumbar scoliosis curve, and from the apex to the lower end-vertebra of the curve: decrease of this angle indicate improvement | 6 and 12 months | 
| Posture: frontal trunk list | Clinical Photographic Postural Assessment Tool: The horizontal distance between C7 and a vertical line drawn from S1: decrease of this measure in millimeter indicate improvement | 6 and 12 months | 
| Posture: frontal pelvic tilt | Clinical Photographic Postural Assessment Tool: The angle formed between the line joining the two anterior superior iliac spine (ASIS) and the horizontal: decrease of this angle indicate improvement | 6 and 12 months | 
| Posture: right sagittal pelvic tilt | Clinical Photographic Postural Assessment Tool: The angle formed between the horizontal and the line joining the posterior superior iliac spine (PSIS) and ASIS on the right side: an angle between 20 and 30 degrees indicate a normal value and a better symmetry between right and left side indicate improvement | 6 and 12 months | 
| Posture: left sagittal pelvic tilt | Clinical Photographic Postural Assessment Tool: The angle formed between the horizontal and the line joining the PSIS and ASIS on the left side: an angle between 20 and 30 degrees indicate a normal value and a better symmetry between right and left side indicate improvement | 6 and 12 months | 
| Posture: scapula asymmetry | Clinical Photographic Postural Assessment Tool: The angle formed by a line drawn from the left and right inferior angles of the scapula and the horizontal: decrease of this angle indicate improvement | 6 and 12 months | 
| Change in back pain | Change in the intensity (score) of back pain on the Numeric Pain Rating Scale score (0 no pain to 10 very important pain), lower value indicate improvement. | 6 and 12 months | 
| Change in score of The youth version of the Child & Adolescent Scale of Participation | Change in score of The youth version of the Child & Adolescent Scale of Participation (CASP): The CASP questionnaire has 20 items x 4 levels from 1 (unable to participate) to 4 (age expected/full participation) with a maximum of 80 points. Higher value indicate improvement (better participation). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cobb angle, Posture, Back pain, Participation, Physiotherapy, Global postural re-education