Development and Validation of the MOBI Questionnaire

NCT03929614 | Unknown DMC

• 1 other identifier: 2018-1756
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Score distribution for the new MOBI questionnaire scales

  To develop a self-report questionnaire to assess the quality of life of scoliotic children treated by a Boston brace. There are 6 sub scales : Emotional well-being (7 items, sub score between 0 and 28, best score is 0); Functional well-being (6 items, subscore between 0 and 24, best score is 0); Physical well-being (4 items, subscore between 0 and 16, best score is 0); Social well-being (6 items, subscore between 0 and 24, best score is 0); Barriers related to Patient (4 items, subscore between 0 and 16, best score is 0); Barriers related to System (3 items, subscore between 0 and 12, best score is 0); Barriers related to Treatment (3 items, subscore between 0 and 12, best score is 0). Total score of the MOBI score is obtained by summing the subscores of all subscales (between 0 and 136, best score is 0).

  At baseline (at recruitment)

• Internal validity, scale MOBI

  Chronbach's alpha coefficient, measured at the first visit and at the second visit.

  At baseline (at recruitment)

• The test-retest reliability of MOBI questionnaire

  The test-retest reliability of MOBI will be evaluated using the intraclass correlation coefficient with about 72 hours interval.

  At baseline (at recruitment)

• The structural validity of the MOBI questionnaire

  Principal component analysis with factor extraction to identify the factorial structure of the MOBI questionnaire.

  At project completion (up to 48 months upon recruitment)

Interventions

MOBI validation OTHER

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.

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

AIS patients with brace treatment.

You may qualify if:

• AIS.
• years old, with brace treatment.
• Ability to read and understand English or French.
• Physical and mental ability to adhere to bracing protocol.

You may not qualify if:

• 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,

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Study Officials

• Hubert Labelle, MD

  Ste Justine's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hubert Labelle, MD

CONTACT

5143454731; hubert.labelle@umontreal.ca

Soraya Barchi

CONTACT

5143454931; soraya.barchi@umontreal.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedist and Principal Investigator

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 29, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

CA (1)