Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT03929614

Conditions

Idiopathic Scoliosis

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

Interventions

MOBI validation

Study Details

Brief 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

Conditions

Idiopathic Scoliosis

Study ID

NCT03929614

Start date

Feb 1, 2019

Status verified date

Jan, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

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,

Study Design

Enrollment

176 participants

Anticipated

Interventions and Outcome Measures

Interventions

MOBI validation

Final version will be distributed to 176 French speaking subjects, 30 of whom are randomly selected and will fill it a second time, at after 72 hrs. To consider of its kind, Moreover, the Bem Inventory for Children will be completed by everyone as well as the SF-12 and SRS-22.

Primary outcome measure

  • Score distribution for the new MOBI questionnaire scales [ Time Frame: At baseline (at recruitment) ]
  • Internal validity, scale MOBI [ Time Frame: At baseline (at recruitment) ]
  • The test-retest reliability of MOBI questionnaire [ Time Frame: At baseline (at recruitment) ]
  • The structural validity of the MOBI questionnaire [ Time Frame: At project completion (up to 48 months upon recruitment) ]

Central Contacts and Locations

Central contacts

Hubert Labelle, MD

5143454731hubert.labelle@umontreal.ca

Soraya Barchi

5143454931soraya.barchi@umontreal.ca

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Hubert Labelle, MD

5143454931hubert.labelle@umontreal.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Jan 10, 2024

Last verified

Jan, 2024

Keywords

  • Brace Treatment
  • Health-related quality of life (HRQOL)
  • Questionnaire development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2024-01-10.