Idiopathic ScoliosisMOBINCT03929614
Development and Validation of the MOBI Questionnaire
An observational study of Idiopathic Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- MOBI validation
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: AIS patients with brace treatment.
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Hubert Labelle, MD, 5143454931, hubert.labelle@umontreal.ca
About this study
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
Read the detailed description
Increase treatment adherence by 50%: 1- by identifying the reasons of non-adherence with MOBI, the first bilingual quality of life (QL) measurement questionnaire dedicated to braces, 2- using for the first time a Multidisciplinary Support Team (MST) for the patient / family.
The BrAIST study showed an inverse correlation between the duration of brace wear and the probability of progression, a wearing time of 0 to 6 hrs / day with a proportion at 59% progression ≥50 ° vs 7% for a brace wear> 17 hours. Knowing that the average daily brace wear duration measured is much lower than that prescribed, there is a problem of compliance whose in which the causes are unknown. Unsuitable questionnaires assessed the QoL of AIS patients on TLSO and have reflected the impact of the disease on psychological health, perceptions of self-image and daily activities, but do not isolate the factors associated with non-compliance to TLSO. In addition, there is no biopsychosocial intervention strategy in care settings to improve compliance.
The investigators have expertise in this field since the investigator have carried out cross-cultural adaptation and validation of 2 QL instruments in the AIS. In addition, the investigator and his team developed a body diagram to evaluate the comfort of patients under brace treatment and correlated with pressure measurements at the skin-brace interface. The investigator's also used in a previous RCT thermal sensors to measure the wearing time of the braces.
The investigator's team propose to develop and validate MOBI (My Orthopedic Brace Inventory), the first bilingual multidimensional QL questionnaire dedicated to the wearing of the brace to measure the physical and functional well-being, emotional and social wellness. We will use MOBI to identify the elements associated with non-compliance to TLSO and for the first time in the world MST, a multi-disciplinary team (nurse, orthotist, psychologist, social worker) to intervene on the 4 identified dimensions, with the assumption that this intervention will improve by 50% the wearing time of the brace.
- Conditions
- Idiopathic Scoliosis
- Being tested
- MOBI validation
- Keywords
- Brace Treatment, Health-related quality of life (HRQOL), Questionnaire development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBI validationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline (at recruitment)
Internal validity, scale MOBI
Chronbach's alpha coefficient, measured at the first visit and at the second visit.
Measured: 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.
Measured: 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.
Measured: At project completion (up to 48 months upon recruitment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Principal investigator, Hubert Labelle, MD, St. Justine's Hospital
- Investigators
- Hubert Labelle, MD, Principal investigator, Ste Justine's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929614
- Sponsor's protocol ID
- 2018-1756
- Acronym
- MOBI
- Status last verified
- Jan 2024
- First submitted
- 2 Apr 2019
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the MOBI Questionnaire
- ClinicalTrials.gov ID
- NCT03929614
- Acronym / sponsor ID
- MOBI / 2018-1756
- Conditions
- Idiopathic Scoliosis
- Keywords
- Brace Treatment, Health-related quality of life (HRQOL), Questionnaire development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Increase treatment adherence by 50%: 1- by identifying the reasons of non-adherence with MOBI, the first bilingual quality of life (QL) measurement questionnaire dedicated to braces, 2- using for the first time a Multidisciplinary Support Team (MST) for the patient / family.
The BrAIST study showed an inverse correlation between the duration of brace wear and the probability of progression, a wearing time of 0 to 6 hrs / day with a proportion at 59% progression ≥50 ° vs 7% for a brace wear> 17 hours. Knowing that the average daily brace wear duration measured is much lower than that prescribed, there is a problem of compliance whose in which the causes are unknown. Unsuitable questionnaires assessed the QoL of AIS patients on TLSO and have reflected the impact of the disease on psychological health, perceptions of self-image and daily activities, but do not isolate the factors associated with non-compliance to TLSO. In addition, there is no biopsychosocial intervention strategy in care settings to improve compliance.
The investigators have expertise in this field since the investigator have carried out cross-cultural adaptation and validation of 2 QL instruments in the AIS. In addition, the investigator and his team developed a body diagram to evaluate the comfort of patients under brace treatment and correlated with pressure measurements at the skin-brace interface. The investigator's also used in a previous RCT thermal sensors to measure the wearing time of the braces.
The investigator's team propose to develop and validate MOBI (My Orthopedic Brace Inventory), the first bilingual multidimensional QL questionnaire dedicated to the wearing of the brace to measure the physical and functional well-being, emotional and social wellness. We will use MOBI to identify the elements associated with non-compliance to TLSO and for the first time in the world MST, a multi-disciplinary team (nurse, orthotist, psychologist, social worker) to intervene on the 4 identified dimensions, with the assumption that this intervention will improve by 50% the wearing time of the brace.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- AIS patients with brace treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOBI validationFinal 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. | Other | – |
Primary outcome
Score distribution for the new MOBI questionnaire scales
Time frame: At baseline (at recruitment)
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).
Internal validity, scale MOBI
Time frame: At baseline (at recruitment)
Chronbach's alpha coefficient, measured at the first visit and at the second visit.
The test-retest reliability of MOBI questionnaire
Time frame: At baseline (at recruitment)
The test-retest reliability of MOBI will be evaluated using the intraclass correlation coefficient with about 72 hours interval.
The structural validity of the MOBI questionnaire
Time frame: At project completion (up to 48 months upon recruitment)
Principal component analysis with factor extraction to identify the factorial structure of the MOBI questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Labelle, MD principal investigator
Ste Justine's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hubert Labelle, MD (5143454731, hubert.labelle@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score distribution for the new MOBI questionnaire scales (time frame: At baseline (at recruitment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.