Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT01705834
Status:
WITHDRAWN
Last Update Posted:
2014-04-09
First Post:
2012-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dataglove to Measure Joint Stiffness in Patients With Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study protocol has been replaced with a two-glove protocol NCT02026245', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-08', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2012-10-11', 'lastUpdatePostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between maximum velocity of movement and the patient reported severity of joint stiffness', 'timeFrame': 'Maximum of 7 days', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Number of patients withdrawing from the study', 'timeFrame': 'Over the period of testing of the dataglove - 7 day timeframe', 'description': 'We are expecting that no more than 30% of patients will withdraw from the study due to discomfort fitting or using the dataglove.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthritis', 'Stiffness', 'Range of movement', 'Goniometry', 'Digital', 'Dataglove', 'Outcome'], 'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Rheumatoid arthritis causing pain and stiffness in their hands.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 18 to 80\n* Diagnosis of Rheumatoid arthritis\n* Patients who have significant pain and stiffness in their hands\n* Correct hand size to achieve a good fit to the dataglove\n* Able to follow instructions for use of dataglove/computer\n\nExclusion Criteria:\n\n* Severe pain in the right hand\n* Severe swelling in the right hand (rated as such by the investigator)\n* Severe permanent deformity or loss of function in the fingers of the right hand\n* Broken or infected skin in the right hand\n* Known to have been MRSA positive currently or in the past\n* Unable to don and doff the disposable lining glove and the dataglove without significant discomfort\n* Poor fit for the disposable lining glove or the dataglove\n* History of latex allergy'}, 'identificationModule': {'nctId': 'NCT01705834', 'briefTitle': 'Dataglove to Measure Joint Stiffness in Patients With Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Western Health and Social Care Trust'}, 'officialTitle': 'The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis', 'orgStudyIdInfo': {'id': 'Dataglove-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arthritis patients', 'description': 'Patients with Rheumatoid Arthritis'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT47 6SB', 'city': 'Londonderry', 'state': 'N.Ireland', 'country': 'United Kingdom', 'facility': 'Department of Rheumatology, Altnagelvin Hospital', 'geoPoint': {'lat': 54.9981, 'lon': -7.30934}}], 'overallOfficials': [{'name': 'Philip Gardiner, MB BCh BAO MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Western Health and Social Services Trust'}, {'name': 'Kevin Curran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulster'}, {'name': 'Joan Condell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulster'}, {'name': 'James Connolly, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Health and Social Care Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ulster', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Rheumatologist', 'investigatorFullName': 'Dr Philip Gardiner', 'investigatorAffiliation': 'Western Health and Social Care Trust'}}}}