Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT03316768
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grip Strength', 'timeFrame': 'one day', 'description': 'Grip Strength'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['grip', 'pinch', 'forces', 'pressure', 'Tekscan', 'sensor', 'ADL', 'activities of daily living', 'work requirements', 'hand biomechanics', 'forceful precision grip', 'power grip', 'hominid', 'hominin', 'prehistoric'], 'conditions': ['Basilar Thumb Arthritis', 'Wrist Fracture', 'Measure Pressure Distribution and Resultant Forces Needed']}, 'descriptionModule': {'briefSummary': 'Very little is known about the pinch and grip forces that are critical for activities of daily living (ADL) or work. Human success in evolution is a result of the combination of great brain power and great hand ability to accomplish with our hands what our minds can conceive. Prehensile grasp in hominins allowed tool production and today allows us to hold fine instruments to perform surgery or do heavy construction. The strength of our hands is matched against the requirements of the activities we need to perform. The hypothesis of this study is that many tasks have an inherent strength requirement that is independent of the person performing the task. Until recently, direct measurement of the forces has not been possible. Ultra thin sensors along with the software to interpret the information is now available to make this force determination possible. We have 3 primary objectives. The primary objective is to measure pressure distribution and resultant forces needed for 3 categories of ADL and 2 categories of work in normal subjects. The second objective is to perform a similar evaluation of patients with basilar thumb arthritis and after wrist fracture. The third objective is to measure pressure distribution and forces needed for tool production and use.', 'detailedDescription': 'The study will measure pressures and forces for ADL and simulated work using healthy volunteers. Sixteen volunteers will be chosen over a range of ages but specifically include similar numbers of early adulthood (18-44), middle age (45-65), and elderly (\\>65). Sixteen volunteers from each age group divided evenly by gender will be selected. Therefore, a total of 48 subjects will be tested, with an even number of male and female performing each of the activities listed above.\n\nInclusion Critera Volunteers will be recruited through website, personnel, and community contacts. They will be recruited based on age and gender.\n\nExclusion Criteria Patients will be excluded if they have a history of an inflammatory condition such as rheumatoid arthritis or lupus. They will be excluded if they have symptomatic osteoarthritis of their hands. Additional exclusion criteria will include known neurologic conditions, or prior injury that may be contributing to weakness or atrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers will be recruited through website, personnel, and community contacts. They will be recruited based on age and sex. Helsinki approval will be obtained before recruiting patients. Informed consent will be obtained.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n* At least 18 years old\n* Willing to participate in the study\n\nExclusion Criteria:\n\n* History of an inflammatory condition such as rheumatoid arthritis or lupus\n* Symptomatic osteoarthritis of their hands\n* Known neurologic condition\n* Prior injury that may be contributing to weakness or atrophy'}, 'identificationModule': {'nctId': 'NCT03316768', 'briefTitle': 'Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production', 'orgStudyIdInfo': {'id': '01D23E57.603E53E0'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}