Vision-based Assessment of Joint Extensibility in Ehlers Danlos Syndrome
NCT ID: NCT05366114
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
225 participants
OBSERVATIONAL
2022-04-26
2024-12-31
Brief Summary
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While there is moderate validity and inter-rater variability in using the Beighton score, there continue to be several challenges with its widespread and consistent application by clinicians. Some of the barriers reported in the literature include:
i) In open, non-standardized systems there can be significant variation in the method to perform these joint extensibility tests including assessing baseline measurements, ii) Determining consistent and standard measurement tools/methodology e.g. goniometer use can vary widely iii) Assessing the reliability of the cut off values and, iv) Performing full assessment prior to informing patients of possible classification of GJH positivity (low specificity and low positive predictive).
Inappropriate implementation of tests to assess GJH results in inaccurate identification of GJH and potentially unintended negative consequences of making the wrong diagnosis of EDS. The objective of this study is to create a more robust and valid method of joint mobility measurement and reduce error in the screening of EDS through use of a smartphone-based machine learning application systems for measurement of joint extensibility.
The project will:
i) Create a smart-phone enabled visual imaging app to assess the measurement of joint extensibility, ii) Assess the feasibility of using the smart-phone app in a clinical setting to screen potential EDS patients, iii) Determine the validity of the application in comparison to in person clinical assessment in a tertiary care academic EDS program. If successful, the smart-phone application could help standardize the care of potential EDS patients in an efficient and cost-effective manner.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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New patients at the GoodHope EDS clinic at Toronto General Hospital
All patients seen in the EDS clinic are eligible for inclusion, regardless of their presenting diagnosis or the results of their assessments.
No intervention, additional video data collection only
No intervention will be used. Consenting participants will have video recordings taken during their exam of joint hypermobility which will be analyzed at a later time
Interventions
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No intervention, additional video data collection only
No intervention will be used. Consenting participants will have video recordings taken during their exam of joint hypermobility which will be analyzed at a later time
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Nimish Mittal
Medical Director - GoodHope Ehlers Danlos Syndrome Clinic
Principal Investigators
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Nimish Mittal, MD
Role: PRINCIPAL_INVESTIGATOR
GoodHope Ehlers Danlos Syndrome Clinic, Toronto General Hospital
Locations
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GoodHope EDS - Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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Critical Care Services Ontario, Ehlers-Danlos Syndrome Expert Panel Report, 2016. https://www.health.gov.on.ca/en/common/ministry/publications/reports/eds/Default.aspx.
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Mittal N, Sabo A, Deshpande A, Clarke H, Taati B. Feasibility of video-based joint hypermobility assessment in individuals with suspected Ehlers-Danlos syndromes/generalised hypermobility spectrum disorders: a single-site observational study protocol. BMJ Open. 2022 Dec 16;12(12):e068098. doi: 10.1136/bmjopen-2022-068098.
Other Identifiers
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22-5073
Identifier Type: -
Identifier Source: org_study_id