Effect of Global Postural Re-education in Idiopathic Scoliosis
Primary Purpose
Idiopathic Scoliosis
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GPR-A
GPR-B
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Scoliosis focused on measuring Physiotherapy, Global postural re-education, Cobb angle, Posture, Back pain, Participation
Eligibility Criteria
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.
Sites / Locations
- CHU Sainte-Justine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
GPR-A
GPR-B
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Change in Cobb angle
Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03663088
Brief Title
Effect of Global Postural Re-education in Idiopathic Scoliosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Because of the COVID-19 pandemic
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
Keywords
Physiotherapy, Global postural re-education, Cobb angle, Posture, Back pain, Participation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GPR-A
Arm Type
Active Comparator
Arm Description
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).
Arm Title
GPR-B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
GPR-A
Intervention Description
Standard Global postural re-education physiotherapy scoliosis specific exercises
Intervention Type
Other
Intervention Name(s)
GPR-B
Intervention Description
Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises
Primary Outcome Measure Information:
Title
Change in Cobb angle
Description
Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Posture: shoulder elevation
Description
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
Time Frame
6 and 12 months
Title
Posture: right waist angle
Description
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
Time Frame
6 and 12 months
Title
Posture: left waist angle
Description
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
Time Frame
6 and 12 months
Title
Posture: thoracic scoliosis
Description
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
Time Frame
6 and 12 months
Title
Posture: lumbar scoliosis
Description
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
Time Frame
6 and 12 months
Title
Posture: frontal trunk list
Description
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
Time Frame
6 and 12 months
Title
Posture: frontal pelvic tilt
Description
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
Time Frame
6 and 12 months
Title
Posture: right sagittal pelvic tilt
Description
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
Time Frame
6 and 12 months
Title
Posture: left sagittal pelvic tilt
Description
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
Time Frame
6 and 12 months
Title
Posture: scapula asymmetry
Description
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
Time Frame
6 and 12 months
Title
Change in back pain
Description
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.
Time Frame
6 and 12 months
Title
Change in score of The youth version of the Child & Adolescent Scale of Participation
Description
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).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Recruitment rate
Description
Percentage of eligible patients recruited: 70% of participants recruited indicate good recruitment rate
Time Frame
12 months
Title
Completion rate
Description
Percentage of recruited participants who completed the trial: 75% of completion indicate good completion rate
Time Frame
12 months
Title
Adherence (compliance) with GPR treatment in terms of collaboration, presence and implication in home exercises
Description
Adherence with GPR treatment will be measured by the physiotherapists using the validated 3-item Sport Injury Rehabilitation Adherence Scale (SIRAS, were total score varies from 3 (low adherence) to 15 (high adherence)). We will also compute presence/absence to therapy and we will use a patient/parent logbook for home exercises. Good adherence (compliance) to treatment will be achieved if a participant has a score of at least 12 out of 15 on the SIRAS 80 % of the treatment sessions, is present to therapy 80% of the sessions and completes home exercises 80% of the time.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Fortin, Ph.D.
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Global Postural Re-education in Idiopathic Scoliosis
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