Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-05 @ 5:15 AM
Study NCT ID:
NCT03837951
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2019-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-29', 'studyFirstSubmitDate': '2019-02-08', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Figure-of-Eight non-injured hands', 'timeFrame': '1 day', 'description': '3 measurements of right and left hands of each non-injured participant by 3 hand therapists'}, {'measure': 'Volumetric measurements on non-injured hands', 'timeFrame': '1 day', 'description': '3 measurements of right and left hands of each non-injured participant'}, {'measure': 'Figure-of-Eight injured hands', 'timeFrame': '1 day', 'description': '3 measurements of right and left hands of each non-injured participant by 3 different hand therapists'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reliability', 'edema', 'physical therapy', 'occupational therapy', 'figure-of-eight'], 'conditions': ['Hand Injuries', 'Edema Arm']}, 'descriptionModule': {'briefSummary': 'This study determined the intra-rater and inter-rater reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. Part B of the study conducted in a clinic, assessed the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.', 'detailedDescription': 'Edema is the retention of fluid in the intracellular spaces, which is common in inflammatory condition such as traumatic injury and post surgical conditions. Edema in the hand and wrist can result in detrimental physiological changes which decrease the range of motion of joint and limit the overall functional capacity and dexterity of the hand. The gold standard Volumetric measurements are reliable for measuring edema changes in upper extremity. Using volumeters can be cumbersome in a busy clinic. Figure-of-eight measurements using a tape measure on the wrist and hand is an easy way to measure edema and can capture the accumulation in the dorsal hand that circumferential tape measurements do not capture. This study was performed in two parts. Part A determined the intra-rater and inter-rater reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight measurements to the gold standard volumetric measurements. No study other study has compared right and left hands. Part B of the study was conducted in a clinic to assess the intra-rater reliability and inter-rater reliability on both hands of patients with hand injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Part A: Thirty healthy participants (10 men and 20 women) were recruited from the student population at a university.\n\nPart B: 17 participants with upper extremity injury (4 men \\& 13 women)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Healthy-part A\n* Recent history of hand or wrist injury with swelling -part B\n\nExclusion Criteria\n\n* Open wounds-part A\n* Current swelling-part A\n* History of injury in either upper extremity-part A\n* Diabetes mellitus-part A\n* Raynaud's Syndrome-part A\n* Pregnant women-part A \\& B\n* Could not speak English-part A \\& B\n* Could not consent for oneself-part A \\& B"}, 'identificationModule': {'nctId': 'NCT03837951', 'briefTitle': 'Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Lowell'}, 'officialTitle': 'Comparison of Figure-of-Eight Hand Measurements to Standard Volumetric Measurements and Its Reliability Within a Clinical Setting With Hand Injured Patients', 'orgStudyIdInfo': {'id': '11-056-LEW-XPD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uninjured hands', 'description': 'healthy participants without injuries to hands or wrists', 'interventionNames': ['Other: Figure-of-eight tape measure measurements on both hands', 'Other: Volumeter measurements']}, {'label': 'Injured hands', 'description': 'participants undergoing medical treatment for recent hand or wrist injury', 'interventionNames': ['Other: Figure-of-eight tape measure measurements on both hands']}], 'interventions': [{'name': 'Figure-of-eight tape measure measurements on both hands', 'type': 'OTHER', 'description': 'Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.', 'armGroupLabels': ['Injured hands', 'Uninjured hands']}, {'name': 'Volumeter measurements', 'type': 'OTHER', 'description': 'Volumeter measurements to uninjured participants had 3 measurements taken of each hand.', 'armGroupLabels': ['Uninjured hands']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erika S. LEWIS, Ed.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, University of Massachusetts Lowell'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planning to share the de-identified data on this population'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Lowell', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Interim DPT Program Director', 'investigatorFullName': 'ELewis', 'investigatorAffiliation': 'University of Massachusetts, Lowell'}}}}