- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06263699
Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease (Goniometry)
July 24, 2025 updated by: Universitaire Ziekenhuizen KU Leuven
Comparing the Accuracy of Clinical Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease
Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease.
In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care.
Using the goniometer can be time consuming.
Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files.
Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease.
In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care.
Using the goniometer to measure the extension deficit of both fingers, for both the proximal interphalangeal (PIP) and metacarpophalangeal (MCP) joint can be a time consuming process.
A lot of clinicians have limited time per patient, which leads to partially or completely missing data due to not performing the measurements.
Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files.
Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer.
Establishing the difference between both methods is essential to monitor change, which makes a statistical comparison of accuracy of both methods very valuable for patients with Dupuytren's disease.
Furthermore, a lot of clinicians have collected and stored standardised pictures of their patient's hands over the years.
Therefore this study could solidify the available data through these images, which provide valuable information for future follow up.
Furthermore, proper patient education could provide the clinician with standardised images taken by the patient himself, leading to improved follow up, if images and clinical measurement prove to be equally accurate.
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- Universitaire Ziekenhuizen KU Leuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with diagnosed Dupuytren's disease
Description
Inclusion Criteria:
- Older than 18 years of age
- Current AED in digit 4 or 5, in the MCP or PIP joint
Exclusion Criteria:
- Abnormalities to the fingers other than Dupuytren's disease which make goniometry impossible (e.g. amputation, arthrodesis of finger joints, deformations due to rheumatoid arthritis etc.)
- Patient's unable to give a written participating consent.
- Younger than 18 years of age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with diagnosed Dupuytren's disease
Range of motion measurement of the MCP and PIP joints in digits 4 and 5
|
standardised picture of the hand in maximal active extension, with the back of the hand positioned on the table's surface
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Extension Deficits (AED)
Time Frame: Baseline
|
AED in the MCP and PIP joints of digit 4 and 5 are measured by using a goniometer
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ilse Degreef, Prof. Dr, Universitaire Ziekenhuizen KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2024
Primary Completion (Actual)
March 3, 2025
Study Completion (Actual)
March 3, 2025
Study Registration Dates
First Submitted
February 8, 2024
First Submitted That Met QC Criteria
February 15, 2024
First Posted (Actual)
February 16, 2024
Study Record Updates
Last Update Posted (Actual)
July 29, 2025
Last Update Submitted That Met QC Criteria
July 24, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S68225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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