Idiopathic ScoliosisNCT03663088
Effect of Global Postural Re-education in Idiopathic Scoliosis
A study testing GPR-A and GPR-B in people with Idiopathic Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- GPR-A and GPR-B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2018to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- GPR-A, GPR-B
- Keywords
- Physiotherapy, Global postural re-education, Cobb angle, Posture, Back pain, Participation
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPR-AOther
Standard Global postural re-education physiotherapy scoliosis specific exercises
GPR-BOther
Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises
| Study group | Role | What they receive |
|---|---|---|
| GPR-A | Active comparator | 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). Receives: Other: GPR-A |
| GPR-B | Experimental | 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). Receives: Other: GPR-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobb angle
Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement
Measured: 6 and 12 months
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start15 Nov 2018
- Primary completion15 Dec 2020
- Study completion1 Mar 2021
Why it stopped: Because of the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carole Fortin, St. Justine's Hospital
- Investigators
- Carole Fortin, Ph.D., Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663088
- Sponsor's protocol ID
- StJustineH_CFortin
- Status last verified
- Oct 2021
- First submitted
- 2 Aug 2018
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03663088
- Acronym / sponsor ID
- StJustineH_CFortin
- Conditions
- Idiopathic Scoliosis
- Keywords
- Physiotherapy, Global postural re-education, Cobb angle, Posture, Back pain, Participation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of the COVID-19 pandemic
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPR-A | Active comparator | Other: GPR-AThe 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). |
| GPR-B | Experimental | Other: GPR-BThe 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). |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPR-AStandard Global postural re-education physiotherapy scoliosis specific exercises | Other | GPR-A |
| GPR-BExperimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises | Other | GPR-B |
Primary outcome
Change in Cobb angle
Time frame: 6 and 12 months
Change in the frontal radiologic measure of scoliosis: a decrease in Cobb angle by more than 5 degrees indicate improvement
12 secondary outcomes
Posture: shoulder elevation
Time frame: 6 and 12 months
Posture: right waist angle
Time frame: 6 and 12 months
Posture: left waist angle
Time frame: 6 and 12 months
Posture: thoracic scoliosis
Time frame: 6 and 12 months
Posture: lumbar scoliosis
Time frame: 6 and 12 months
Posture: frontal trunk list
Time frame: 6 and 12 months
Posture: frontal pelvic tilt
Time frame: 6 and 12 months
Posture: right sagittal pelvic tilt
Time frame: 6 and 12 months
Posture: left sagittal pelvic tilt
Time frame: 6 and 12 months
Posture: scapula asymmetry
Time frame: 6 and 12 months
Change in back pain
Time frame: 6 and 12 months
Change in score of The youth version of the Child & Adolescent Scale of Participation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Because of the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Fortin, Ph.D. principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPR-A and GPR-B in people with Idiopathic Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because of the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cobb angle (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.