Dataglove to Measure Joint Stiffness in Patients With Arthritis

Withdrawn

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT01705834
• Lead Sponsor: Western Health and Social Care Trust

Brief Summary

This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis.

Detailed Description

We will use a dataglove to record joint movements in a small number of patients with rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements measured by the glove will correlate with symptoms of joint stiffness in the hands of patients with rheumatoid arthritis.

Study Timeline

• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male and female patients aged 18 to 80
• Diagnosis of Rheumatoid arthritis
• Patients who have significant pain and stiffness in their hands
• Correct hand size to achieve a good fit to the dataglove
• Able to follow instructions for use of dataglove/computer

Exclusion Criteria

• Severe pain in the right hand
• Severe swelling in the right hand (rated as such by the investigator)
• Severe permanent deformity or loss of function in the fingers of the right hand
• Broken or infected skin in the right hand
• Known to have been MRSA positive currently or in the past
• Unable to don and doff the disposable lining glove and the dataglove without significant discomfort
• Poor fit for the disposable lining glove or the dataglove
• History of latex allergy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between maximum velocity of movement and the patient reported severity of joint stiffness	Maximum of 7 days	A significant inverse correlation is expected to be found between the patient's assessment of the severity and/or duration of stiffness and the maximum velocity of movement at the main finger joints.

Secondary Outcome Measures

Name	Time	Method
Number of patients withdrawing from the study	Over the period of testing of the dataglove - 7 day timeframe	We are expecting that no more than 30% of patients will withdraw from the study due to discomfort fitting or using the dataglove.

Trial Locations

Locations (1)

Department of Rheumatology, Altnagelvin Hospital; 🇬🇧 Londonderry, N.Ireland, United Kingdom