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NCT01705834 Clinical Trial

Dataglove to Measure Joint Stiffness in Patients With Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:
The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01705834
Other study ID # Dataglove-01
Secondary ID
Status Withdrawn
Phase N/A
First received October 4, 2012
Last updated April 8, 2014

Study information
Verified date April 2014
Source Western Health and Social Care Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Department of Rheumatology, Altnagelvin Hospital Londonderry N.Ireland

Sponsors (2)
Lead Sponsor Collaborator
Western Health and Social Care Trust University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between maximum velocity of movement and the patient reported severity of joint stiffness 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. Maximum of 7 days No
Secondary Number of patients withdrawing from the study We are expecting that no more than 30% of patients will withdraw from the study due to discomfort fitting or using the dataglove. Over the period of testing of the dataglove - 7 day timeframe No
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