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Dataglove to Measure Joint Stiffness in Patients With Arthritis

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ClinicalTrials.gov Identifier: NCT01705834
Recruitment Status : Withdrawn (The study protocol has been replaced with a two-glove protocol NCT02026245)
First Posted : October 12, 2012
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
University of Ulster
Information provided by (Responsible Party):
Dr Philip Gardiner, 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.

Condition or disease
Arthritis, Rheumatoid

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis

Resource links provided by the National Library of Medicine


Group/Cohort
Arthritis patients
Patients with Rheumatoid Arthritis



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Rheumatoid arthritis causing pain and stiffness in their hands.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705834


Locations
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United Kingdom
Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, United Kingdom, BT47 6SB
Sponsors and Collaborators
Western Health and Social Care Trust
University of Ulster
Investigators
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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

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Responsible Party: Dr Philip Gardiner, Consultant Rheumatologist, Western Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01705834     History of Changes
Other Study ID Numbers: Dataglove-01
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by Dr Philip Gardiner, Western Health and Social Care Trust:
Arthritis
Stiffness
Range of movement
Goniometry
Digital
Dataglove
Outcome
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases