Development and Validation of the MOBI Questionnaire

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Scoliosis is a common spinal deformity in adolescents. Orthopedic brace treatment is the only conservative (nonsurgical) treatment effective in limiting the progression of this deformity. It is a difficult treatment for young people (discomfort, self-image, limitation in activities) who must wear this rigid orthosis between 20-23 hrs / day during the growth spurt. Recent studies have shown that the effectiveness of this treatment is related to the wearing time of the corset. However, there is a serious problem of compliance to treatment. On average, the brace is worn only 12 hrs / day. A negative perception of the patient with respect to the brace can lead to treatment failure if the brace is not worn. It is therefore essential to understand the impact of the brace on the quality of psychological life, the daily activities and the comfort of young patients. Unfortunately, there is no valid instrument to evaluate all these dimensions. The objective of this project is to develop a questionnaire that can measure the quality of life of patients wearing a brace and validate it for its clinical use. The investigators have created a questionnaire based on the best knowledge published on the subject, opinions of experts in the field and a group of patient partners. At the end of this project, a questionnaire will be available for the first time to assess in depth the perception that patients have of their braces. It can be used to adjust braces in the clinic, as well as to support and encourage compliance to the treatment

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
CHU Sainte-Justine
RECRUITING
Montreal
Contact Information
Primary
Hubert Labelle, MD
hubert.labelle@umontreal.ca
5143454731
Backup
Soraya Barchi
soraya.barchi@umontreal.ca
5143454931
Time Frame
Start Date: 2019-02-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 176
Related Therapeutic Areas
Sponsors
Leads: St. Justine's Hospital
Collaborators: Shriners Hospitals for Children

This content was sourced from clinicaltrials.gov