Dataglove to Measure Joint Stiffness in Patients With Arthritis

April 8, 2014 updated by: Dr Philip Gardiner, Western Health and Social Care Trust

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

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

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

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

  • United Kingdom
    • N.Ireland
      • Londonderry, N.Ireland, United Kingdom, BT47 6SB
        • Department of Rheumatology, Altnagelvin Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Rheumatoid arthritis causing pain and stiffness in their hands.

Description

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 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
Arthritis patients
Patients with Rheumatoid Arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between maximum velocity of movement and the patient reported severity of joint stiffness
Time Frame: 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.
Maximum of 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients withdrawing from the study
Time Frame: 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.
Over the period of testing of the dataglove - 7 day timeframe

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Health and Social Care Trust

Collaborators

University of Ulster

Investigators

  • Study Chair: Philip Gardiner, MB BCh BAO MD, Western Health and Social Services Trust
  • Principal Investigator: Kevin Curran, PhD, University of Ulster
  • Principal Investigator: Joan Condell, PhD, University of Ulster
  • Principal Investigator: James Connolly, BSc, University of Ulster

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 Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dataglove-01

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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