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Effect of Global Postural Re-education in Idiopathic Scoliosis

NCT03663088 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-14

No results posted yet for this study

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.

Conditions

  • Idiopathic Scoliosis

Interventions

OTHER

GPR-A

Standard Global postural re-education physiotherapy scoliosis specific exercises

OTHER

GPR-B

Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Carole Fortin, Ph.D. · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2020-12-15
Completion
2021-03-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03663088 on ClinicalTrials.gov