Exercises to manage mild idiopathic scoliosis in children
PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis
This study tests whether a special exercise program can help children with mild scoliosis improve their spine curve and quality of life compared to just being watched without treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 9 Years to 15 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Linköping and 1 other locations) |
| Trial ID | NCT05138393 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of scoliosis-specific exercises in managing mild idiopathic scoliosis in skeletally immature children. Participants will be randomly assigned to either an active self-corrective exercise program or observation without intervention. The study aims to assess changes in curve severity, quality of life, and the necessity for brace treatment over time. Compliance with the exercise regimen will be monitored through a mobile application, ensuring direct communication with research personnel. Regular clinical and radiological follow-ups will be conducted to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are skeletally immature children aged 9-15 years with a Cobb angle of 15-24 degrees and no prior treatment for scoliosis.
Not a fit: Patients with non-idiopathic scoliosis or those who have previously undergone surgical or brace treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for bracing or surgical interventions in children with mild idiopathic scoliosis.
How similar studies have performed: While there have been various approaches to scoliosis-specific exercises, this particular method is being rigorously tested in a randomized controlled trial, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cobb 15-24 degrees * Skeletally immature, Sanders score of 4 or less and Risser \< 2. * No menarche for females * Aged 9-15 years * Apex of the primary curve at T7 or caudal Exclusion Criteria: * Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis) * No previous surgical or brace treatment for scoliosis
Where this trial is running
Linköping and 1 other locations
- Linköping university hospital — Linköping, Sweden (Recruiting)
- Karolinska university hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Elias Diarbakerli, PT, PhD — Karolinska Institutet
- Study coordinator: Elias Diarbakerli, PT, PhD
- Email: elias.diarbakerli@regionstockholm.se
- Phone: +460851770000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.