Clinical Trials Directory

Trials / Terminated

TerminatedNCT03663088

Effect of Global Postural Re-education in Idiopathic Scoliosis

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
St. Justine's Hospital · Academic / Other
Sex
All
Age
8 Years – 16 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERGPR-AStandard Global postural re-education physiotherapy scoliosis specific exercises
OTHERGPR-BExperimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises

Timeline

Start date
2018-11-15
Primary completion
2020-12-15
Completion
2021-03-01
First posted
2018-09-10
Last updated
2021-10-14

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03663088. Inclusion in this directory is not an endorsement.