Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-01 @ 3:09 AM
Study NCT ID:
NCT03876405
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000673', 'term': 'Amputation, Traumatic'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Myoelectric Control - ACMC', 'timeFrame': '2 days', 'description': "An observational assessment where you rate the subjects' capacity of myoelectric control in a bimanual activity. The scoring was made by an experienced external rater."}, {'measure': 'Task performance questionnaire', 'timeFrame': '2 days', 'description': '21 questions about sensory feedback from the prosthesis, agency, body ownership, performance in activity and phantom limb pain. Self-administered estimation on a 7 grade Likert-scale.'}, {'measure': 'Pointing task', 'timeFrame': '2 days', 'description': 'A objective measurement of body ownership. The subject are asked to mark on a ruler, with the hand prosthesis hidden, where they estimate the location of the prosthetic index finger.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hand prosthesis', 'sensory feedback', 'amputation', 'upper limb'], 'conditions': ['Amputation, Traumatic', 'Prosthesis User']}, 'referencesModule': {'references': [{'pmid': '32733187', 'type': 'DERIVED', 'citation': 'Wijk U, Carlsson IK, Antfolk C, Bjorkman A, Rosen B. Sensory Feedback in Hand Prostheses: A Prospective Study of Everyday Use. Front Neurosci. 2020 Jul 7;14:663. doi: 10.3389/fnins.2020.00663. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.', 'detailedDescription': 'A non invasive sensory feedback system in embedded in the prosthetic socket will be tested on forearm amputees in their everday life. Pretests and follow up will contain objective outcome assessments and semi-structured interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acquired forearm amputation\n\nExclusion Criteria:\n\n* psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT03876405', 'briefTitle': 'Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses', 'organization': {'class': 'OTHER', 'fullName': 'Lund University Hospital'}, 'officialTitle': 'Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses in Everyday Life.', 'orgStudyIdInfo': {'id': 'SFB2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sensory feedback', 'description': 'A non-invasive air-mediated sensory feedback system embedded in the prosthesis socket.\n\nGroup description: Individuals with acquired forearm amputation.', 'interventionNames': ['Device: smartskin non-invasive sensory feedback']}], 'interventions': [{'name': 'smartskin non-invasive sensory feedback', 'type': 'DEVICE', 'description': 'The sensory feedback system used was a simple non-invasive, non-electronic system based on air-mediated pressure. A silicone glove with bulbs (35 mm in length) volar in every fingertip was made and applied on a VariPlus Speed hand (OttoBock), size 7¾.\n\nThe sensory feedback system was embedded in the prosthetic socket.', 'armGroupLabels': ['sensory feedback']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ulrika Wijk', 'investigatorAffiliation': 'Lund University Hospital'}}}}