Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:26 AM
Study NCT ID:
NCT07388303
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceived Ability and Hand Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D005543', 'term': 'Forearm Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Modified Hand Injury Severity Score', 'timeFrame': 'At baseline', 'description': 'It is a four-component scoring system developed to determine the severity of hand and forearm injuries: integumentary (skin and nail), skeletal (bone and ligament), motor (tendon), and neurovascular (nerve and vascular). The total score is obtained by summing the scores of all components and is classified into four categories: minor (\\<20), moderate (21-50), severe (51-100), and major (\\>101) injury.'}, {'measure': 'Manual Ability Measure-36', 'timeFrame': 'At the 6th and 12th weeks following injury or surgery', 'description': "It is a self-report questionnaire specifically developed to measure hand dexterity. It is an outcome measure that reflects patients' perceived functional hand use or their ability to perform activities of daily living. Higher scores indicate higher levels of function."}, {'measure': 'The Jebsen-Taylor Hand Function Test', 'timeFrame': 'At the 6th and 12th weeks following injury or surgery', 'description': 'It consists of seven subtests: writing, turning over cards, picking up small common objects, simulated feeding, stacking checkers, moving light objects, and moving heavy objects.'}, {'measure': 'The Nine-Hole Peg Test', 'timeFrame': 'At the 6th and 12th weeks following injury or surgery', 'description': 'It is a simple, rapid, and manual dexterity test with proven validity and reliability. It is particularly sensitive to changes in upper extremity performance.'}, {'measure': 'Gross and fine grip strength', 'timeFrame': 'At the 6th and 12th weeks following injury or surgery', 'description': 'These measurements are performed according to the procedure recommended by the American Society of Hand Therapists.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hand forearm injuries', 'perceived manual ability', 'functional measurements'], 'conditions': ['Hand Injuries', 'Forearm Injuries']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Rallon, C. R., & Chen, C. C. (2008). Relationship between performance-based and self-reported assessment of hand function. American Journal of Occupational Therapy, 62(5), 574-579.'}, {'type': 'BACKGROUND', 'citation': 'Chen, C. C., & Bode, R. K. (2010). Psychometric validation of the Manual Ability Measure-36 (MAM-36) in patients with neurologic and musculoskeletal disorders. Archives of physical medicine and rehabilitation, 91(3), 414-420.'}]}, 'descriptionModule': {'briefSummary': 'Patient-reported outcome measures, which are subjective by nature, need to be correlated with clinician-administered professional measurements as a further step toward expanding their clinical utility. Therefore, this study aimed to investigate the relationship between perceived manual dexterity and functional measurements in patients with hand-forearm injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated conservatively or surgically in the orthopedics clinic due to hand-forearm injuries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having sustained a hand and/or forearm injury and/or having undergone surgery related to this injury.\n* Being voluntary to participate in the study.\n\nExclusion Criteria:\n\n* Patients with concomitant central nervous system involvement.\n* Patients with a history of previous injury to the same extremity.\n* Patients with rheumatological disorders.'}, 'identificationModule': {'nctId': 'NCT07388303', 'briefTitle': 'Perceived Ability and Hand Function', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'The Relationship Between Perceived Manual Ability and Functional Measurements in Patients With Hand-Forearm Injuries', 'orgStudyIdInfo': {'id': 'E-60116787-020-125116'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated conservatively or surgically in the orthopedics clinic due to hand-forearm injuries', 'interventionNames': ['Other: Questionnaire and Physical Exam']}], 'interventions': [{'name': 'Questionnaire and Physical Exam', 'type': 'OTHER', 'description': "The Modified Hand Injury Severity Score is used to determine the severity level of patients' injuries. At the 6th and 12th weeks following the injury or surgery, patients are administered the Manual Ability Measure-36 questionnaire, and the Jebsen-Taylor Hand Function Test and Nine-Hole Peg Test are performed. Additionally, the grip strength of the subjects is evaluated at the 12th week.", 'armGroupLabels': ['Patients treated conservatively or surgically in the orthopedics clinic due to hand-forearm injuries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20170', 'city': 'Denizli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Umut Eraslan', 'role': 'CONTACT', 'email': 'ueraslan@pau.edu.tr', 'phone': '+905444126520'}], 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'centralContacts': [{'name': 'UMUT ERASLAN', 'role': 'CONTACT', 'email': 'ueraslan@pau.edu.tr', 'phone': '+905444126520'}], 'overallOfficials': [{'name': 'Umut Eraslan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'UMUT ERASLAN', 'investigatorAffiliation': 'Pamukkale University'}}}}