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
| Type | Name | Description |
|---|---|---|
| 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 |
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.