Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:18 AM
Study NCT ID:
NCT07347561
Status:
RECRUITING
Last Update Posted:
2026-01-16
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Myoelectric and Bionic Hands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2026-01-09', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper Limb Functionol Index-15', 'timeFrame': 'Baseline', 'description': 'The Upper Limb Functional Index-15 (ULFI-15) is a 15-item patient-reported outcome measure used to assess functional limitations related to the upper extremity. It evaluates difficulties in daily activities, movement, and functional performance of the upper limb. Higher scores indicate greater functional limitation.'}, {'measure': 'Amputee Body Image Scale', 'timeFrame': 'Baseline', 'description': 'The Amputee Body Image Scale (ABIS) is a self-reported questionnaire designed to assess body image perception and body-related concerns in individuals with limb amputation. It measures the psychological impact of amputation on body image, with higher scores reflecting greater body image disturbance.'}, {'measure': "Orthotics and Prosthetics Users' Survey", 'timeFrame': 'Baseline', 'description': "The Orthotics and Prosthetics Users' Survey (OPUS) is a validated patient-reported outcome measure used to evaluate functional status, satisfaction, and quality of life in individuals using orthotic or prosthetic devices. It assesses the user's perceived functional ability and satisfaction with their prosthetic device and related services."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amputation', 'bionic hand', 'myoelectric hand', 'prosthesis', 'trans-humeral', 'trnas-radial'], 'conditions': ['Amputation', 'Upper Limb Amputation', 'Prosthesis']}, 'referencesModule': {'references': [{'pmid': '26230500', 'type': 'RESULT', 'citation': 'Carey SL, Lura DJ, Highsmith MJ; CP; FAAOP. Differences in myoelectric and body-powered upper-limb prostheses: Systematic literature review. J Rehabil Res Dev. 2015;52(3):247-62. doi: 10.1682/JRRD.2014.08.0192.'}, {'type': 'RESULT', 'citation': 'Kannenberg, A., Lundstrom, R., Hibler, K. D., & Johnson, S. S. (2023). Differences in two multiarticulating myoelectric hands for facilitating activities of daily living in individuals with transradial amputation: a cross-sectional study. JPO: Journal of Prosthetics and Orthotics, 35(1), 38-43.'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims to compare myoelectric and bionic hands in terms of upper extremity function, body image and satisfaction.\n\nThe main questions it aims to answer are:\n\n\\- Does upper extremity function differ between bionic and myoelectric hands?\n\nThe main questions it aims to answer are:\n\nDoes upper extremity function differ between bionic and myoelectric hands?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included individuals aged 8-65 who had undergone upper limb amputation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 65 years\n* Individuals with unilateral upper limb amputation\n* Regular use of a prosthetic device for at least 6 months\n* Use of a semi-electronic elbow joint prosthetic component\n* Ability to understand and complete study assessments\n\nExclusion Criteria:\n\n* Presence of bilateral or multiple limb amputations\n* Proximal upper limb amputation at the shoulder level or above\n* Coexisting neurological or orthopedic disorders that may affect upper limb function or study outcomes'}, 'identificationModule': {'nctId': 'NCT07347561', 'briefTitle': 'A Comparison of Myoelectric and Bionic Hands', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'Myoelectric and Bionic Hands in Upper Limb Amputations: A Comparison of Body Image, Function and User Satisfaction', 'orgStudyIdInfo': {'id': 'O&P'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bionic Prosthetic Hand Group', 'description': 'Participants use advanced myoelectric prosthetic hands with multi-articulating structures and enhanced control features designed to improve functional performance.These devices are designed to enhance hand function, dexterity, and user interaction beyond conventional myoelectric control.'}, {'label': 'Myoelectric Prosthetic Hand Group', 'description': 'Participants in this group are individuals with upper limb amputation who use a myoelectric prosthetic hand controlled by surface electromyographic signals from residual limb muscles. These devices provide electrically powered hand movement and basic grasp functions without advanced bionic or sensor-integrated features.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'state': 'Keçiören', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Güllü Yağcıoğlu', 'role': 'CONTACT', 'email': 'gulluaydin23@gmail.com', 'phone': '05536140823'}], 'facility': 'University of Health Sciences Gülhane Faculty of Health Sciences', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Güllü AYDIN YAĞCIOĞLU, Asst. Prof', 'role': 'CONTACT', 'email': 'gulluaydin23@gmail.com', 'phone': '+905536140823'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof', 'investigatorFullName': 'Güllü Aydın Yağcıoğlu', 'investigatorAffiliation': 'Gulhane School of Medicine'}}}}