Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00074893
Status:
COMPLETED
Last Update Posted:
2006-03-08
First Post:
2003-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protective Brace to Prevent Hand and Arm Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2004-02'}, 'lastUpdateSubmitDate': '2006-03-06', 'studyFirstSubmitDate': '2003-12-23', 'studyFirstSubmitQcDate': '2003-12-23', 'lastUpdatePostDateStruct': {'date': '2006-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-12-24', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Repetitive Strain Injuries', 'Vibration Damping', 'Protective Brace', 'Piezoelectric', 'SmartWear'], 'conditions': ['Cumulative Trauma Disorders', 'Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'When people use hand-held power tools, their hands and arms vibrate along with the tool they are holding. People who frequently use hand-held power tools may develop injuries related to this vibration. This study will evaluate a protective brace designed to prevent vibration-related hand and arms injuries.', 'detailedDescription': 'Workers who use hand-held power tools absorb significant vibration energy in their arms and hands and may develop musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and hand-arm vibration syndrome. Protective braces may be worn to decrease the incidence of occupational MSDs. The National Institute for Occupational Safety and Health has identified key attributes for protective braces; these attributes include vibration damping, comfort, non-interference with worker dexterity, and maintenance of safe hand temperature. Most currently available braces do not adequately address these NIOSH requirements. This study will evaluate the efficacy of a brace with piezoelectric damping material.\n\nParticipants in the study will be fitted with a brace on each hand. One brace will have piezoelectric damping material and the other will be a currently available, off-the-shelf commercial brace. Hand-held joysticks and handles mounted to a vibration shaker table will be used to simulate power tool use. Participants will undergo a series of tests designed to measure hand acceleration and vibration while grasping the study joysticks and handles. The tests will take approximately 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal hand anatomy and full range of motion\n\nExclusion Criteria:\n\n* History of significant hand or wrist arthritis\n* Open wounds\n* Prior hand or wrist surgery\n* Neuropathies\n* Skin hypersensitivity\n* Contact dermatitis\n* Reflex sympathetic dystrophy'}, 'identificationModule': {'nctId': 'NCT00074893', 'briefTitle': 'Protective Brace to Prevent Hand and Arm Injuries', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)'}, 'officialTitle': 'Shock Absorbing Brace for Study of Upper Extremity Musculoskeletal Disorders', 'orgStudyIdInfo': {'id': 'NIAMS-079'}, 'secondaryIdInfos': [{'id': '1R43AR049167-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43AR049167-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'piezoelectric wrist brace', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-6902', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hand Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Michael D. Pottenger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SmartWear, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}}}}