Dataglove to Measure Joint Stiffness in Patients With Arthritis

NCT01705834 | Withdrawn

• 1 other identifier: Dataglove-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis; Stiffness; Range of movement; Goniometry; Digital; Dataglove; Outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of patients withdrawing from the study

  Over the period of testing of the dataglove - 7 day timeframe

Study Arms (1)

Arthritis patients

Patients with Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Health and Social Care Trust: lead
• University of Ulster: collaborator

Study Sites (1)

Department of Rheumatology, Altnagelvin Hospital

Londonderry, N.Ireland, BT47 6SB, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Philip Gardiner, MB BCh BAO MD

  Western Health and Social Services Trust

  STUDY CHAIR

• Kevin Curran, PhD

  University of Ulster

  PRINCIPAL INVESTIGATOR

• Joan Condell, PhD

  University of Ulster

  PRINCIPAL INVESTIGATOR

• James Connolly, BSc

  University of Ulster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Rheumatologist

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 12, 2012
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

GB (1)