Creating a questionnaire to improve brace treatment for scoliosis
Development and Validation of the MOBI Questionnaire
This study is trying to create a new questionnaire to help understand how brace treatment affects teenagers with scoliosis and to find ways to help them stick to their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 176 (estimated) |
| Ages | 10 Years to 16 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT03929614 on ClinicalTrials.gov |
What this trial studies
This project aims to develop and validate the MOBI Questionnaire, a bilingual tool designed to assess the health-related quality of life for adolescents undergoing brace treatment for idiopathic scoliosis. The study will identify reasons for non-adherence to brace wearing and utilize a Multidisciplinary Support Team to support patients and their families. By understanding the psychological and physical impacts of brace treatment, the study seeks to enhance treatment adherence and ultimately improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-16 diagnosed with idiopathic scoliosis who are currently undergoing brace treatment.
Not a fit: Patients with other musculoskeletal or developmental illnesses, neurological disorders, or conditions affecting the lower limbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve adherence to brace treatment, leading to better management of idiopathic scoliosis in adolescents.
How similar studies have performed: Previous studies have shown the importance of adherence to brace treatment in scoliosis management, but the specific approach of developing a dedicated quality of life questionnaire is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AIS. * 10-16 years old, with brace treatment. * Ability to read and understand English or French. * Physical and mental ability to adhere to bracing protocol. Exclusion Criteria: * Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature. * Patients with symptom of a neurological disorder. * Patients with any other disorder of the musculoskeletal system affecting the lower limbs,
Where this trial is running
Montréal, Quebec
- CHU Sainte-Justine — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Hubert Labelle, MD — Ste Justine's
- Study coordinator: Hubert Labelle, MD
- Email: hubert.labelle@umontreal.ca
- Phone: 5143454731
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.