Postural Re-education for Adolescent Scoliosis

(RCT-RPG Trial)

Recruiting at 1 trial location

Overseen By Carole Fortin, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Non-AIS diagnosis, Planned surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 months

47 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to see if GPR, a type of physical therapy focusing on posture and muscle exercises, can help adolescents with scoliosis. The goal is to improve their spine alignment, reduce pain, and enhance their overall physical health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is postural re-education generally safe for humans?

The available research does not provide specific safety data for postural re-education methods like Global Postural Re-education, but similar treatments like biofeedback postural training have been used in children with scoliosis without reported safety issues. ^{1 2 3 4 5}

How does the treatment Global postural re-education differ from other treatments for adolescent scoliosis?

Global postural re-education (GPR) is unique because it focuses on teaching patients to actively correct their posture and reduce spinal curvature through specific exercises, rather than relying solely on external supports like braces. This approach emphasizes the patient's ability to self-correct and improve their posture through guided physiotherapy sessions. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Global postural re-education for adolescent scoliosis?

The research highlights that adolescents with scoliosis often have poor postural control compared to healthy peers, suggesting that treatments focusing on improving posture, like Global postural re-education, could be beneficial. Although the studies do not directly evaluate this specific treatment, they emphasize the importance of addressing postural balance in managing scoliosis. ^{1 2 7 10 11}

Who Is on the Research Team?

Carole Fortin, PhD

Principal Investigator

CHU Sainte-Justine/Université de Montréal

Are You a Good Fit for This Trial?

This trial is for adolescents aged 10-16 with mild to moderate scoliosis (Cobb angle between 15º and 45º) who are still growing (Risser sign ≤3) and can travel weekly for treatment. It's not for those planning surgery, already wearing a brace for three months, or with conditions other than Adolescent Idiopathic Scoliosis.

Inclusion Criteria

having recent x-rays (4-6 weeks)

with a risk of progression index > 1.3

I can travel weekly for the treatment.

Exclusion Criteria

worn a brace for at least three months prior to GPR intervention

I am scheduled for surgery.

I have undergone surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care or GPR intervention for scoliosis management

12 months

Weekly sessions for 6 months, bi-weekly sessions for 6 months

Follow-up

Participants are monitored for scoliosis progression, back pain, and quality of life

12 months

Evaluations at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Global postural re-education

Trial Overview The study tests if Global Postural Re-education (GPR), involving special exercises and posture training, can help manage scoliosis better than standard care alone. Participants will be randomly assigned to receive either GPR plus standard care or just standard care over a period of up to one year.

How Is the Trial Designed?

Group I: GPR group Experimental Treatment 1 Intervention

GPR interventions added to standard care (observation or brace)

Group II: Standard care group Active Control 1 Intervention

Observation or brace plus conventional physiotherapy exercises on video

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

CHU de Québec

Collaborator

Trials

2

Recruited

140+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Shriners Hospitals for Children

Collaborator

Trials

98

Recruited

23,900+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Bi-planar spinal stereoradiography of adolescent idiopathic scoliosis: considerations in 3D alignment and functional balance. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Reliability and concurrent validity of postural asymmetry measurement in adolescent idiopathic scoliosis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Trunk balance, head posture and plantar pressure in adolescent idiopathic scoliosis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Postural equilibrium in adolescent idiopathic scoliosis. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Effect of Chêneau brace on postural balance in adolescent idiopathic scoliosis: a pilot study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of an Innovative Biofeedback SKOL-AS&#174; Treatment on the Body Posture and Trunk Rotation in Children with Idiopathic Scoliosis-Preliminary Study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Does postural stability differ between adolescents with idiopathic scoliosis and typically developed? A systematic literature review and meta-analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Global postural re-education in pediatric idiopathic scoliosis: a biomechanical modeling and analysis of curve reduction during active and assisted self-correction. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Analysis of sensory system aspects of postural stability during quiet standing in adolescent idiopathic scoliosis patients. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Use of Postural Reconstruction® physiotherapy to treat an adolescent with asymmetric bilateral genu varum and idiopathic scoliosis. [2013]