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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06263699
Other study ID # S68225
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 29, 2024
Est. completion date January 1, 2025

Study information

Verified date February 2024
Source Universitaire Ziekenhuizen KU Leuven
Contact Ilse Degreef, Prof. Dr.
Phone +32 16 33 88 43
Email ilse.degreef@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 59
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
ROM 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

Locations

Country Name City State
Belgium Universitaire Ziekenhuizen KU Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Active Extension Deficits (AED) AED in the MCP and PIP joints of digit 4 and 5 are measured by using a goniometer Baseline
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