Adolescent Idiopathic ScoliosisRCT-RPGNCT04568759
Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
A study testing Global postural re-education in people with Adolescent Idiopathic Scoliosis, run by St. Justine's Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Global postural re-education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Aug 2021to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Centre interdisciplinaire de recherche en réadaptation et intégration sociale/Université Laval
Québec, G1M 2S8
About this study
Official title: Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Global postural re-education
- Keywords
- adolescent idiopathic scoliosis, Global postural re-education, back pain, quality of life, trunk imbalance, inter muscular coherence, respiratory function, functional performance
- Medical subject headings
- Back Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global postural re-educationOther
GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | Active comparator | Observation or brace plus conventional physiotherapy exercises on video Receives: Other: Global postural re-education |
| GPR group | Experimental | GPR interventions added to standard care (observation or brace) Receives: Other: Global postural re-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobb angle of at least 5 degrees
Angle measured on radiograph for scoliosis progression
Measured: 6, 12 and 24 months
Secondary outcomes (4)
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)
Measured: 6, 12 and 24 months
Italian Spine Youth Quality of Life questionnaire
Quality of life: score is between 0 and 100, where 100 represents a higher quality of life
Measured: 6, 12 and 24 months
Trunk imbalance
The right/left horizontal deviation between the plumb line placed at C7 and S1 calculated in mm
Measured: 6 and 12 months
Diaphragm excursion
Diaphragm excursion using ultrasound imaging in mm
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start15 Aug 2021
- Primary completion1 Mar 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Shriners Hospitals for Children, Université de Montréal, CHU de Québec
- Responsible party
- Principal investigator, Carole Fortin, St. Justine's Hospital
- Investigators
- Carole Fortin, PhD, Principal investigator, CHU Sainte-Justine/Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568759
- Sponsor's protocol ID
- 2021-3065_RCT-RPG
- Acronym
- RCT-RPG
- Status last verified
- Dec 2024
- First submitted
- 23 Sep 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent
- ClinicalTrials.gov ID
- NCT04568759
- Acronym / sponsor ID
- RCT-RPG / 2021-3065_RCT-RPG
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Laval University, Shriners Hospitals for Children, Université de Montréal, CHU de Québec
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Sep 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care group | Active comparator | Other: Global postural re-educationObservation or brace plus conventional physiotherapy exercises on video |
| GPR group | Experimental | Other: Global postural re-educationGPR interventions added to standard care (observation or brace) |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Global postural re-educationGPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities | Other | GPR group, Standard care group |
Primary outcome
Change in Cobb angle of at least 5 degrees
Time frame: 6, 12 and 24 months
Angle measured on radiograph for scoliosis progression
4 secondary outcomes
Back pain on the Numerical Pain Rating Scale
Time frame: 6, 12 and 24 months
Italian Spine Youth Quality of Life questionnaire
Time frame: 6, 12 and 24 months
Trunk imbalance
Time frame: 6 and 12 months
Diaphragm excursion
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No. No plan to share IPD
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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, PhD principal investigator
CHU Sainte-Justine/Université de Montréal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global postural re-education in people with Adolescent Idiopathic Scoliosis, run by St. Justine's Hospital at 2 sites 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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 of at least 5 degrees (time frame: 6, 12 and 24 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 16 Dec 2024.