Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-05 @ 9:12 AM
Study NCT ID:
NCT03995069
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Sponsor:
Organization:
Raw JSON
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Johnson VA Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During the study participation (approximately 10 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Visual Feedback of 3D Digit Force', 'description': "The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.\n\n3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions.", 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 18, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Visual Feedback of 1D Digit Force', 'description': "The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.\n\n1D: Practice generating grip force to the target shown on the computer screen in 1 dimension.", 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 18, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'other adverse events', 'notes': 'high blood pressure, dog bite, sore throat, fatigue, pain, etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tremor with new seizure medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'car accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'transient amnesia, blackout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Action Research Arm Test (ARAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visual Feedback of 3D Digit Force', 'description': "The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.\n\n3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions."}, {'id': 'OG001', 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'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to within 1 week post intervention', 'description': 'Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. 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Scale 0-100. A higher score represents better function (less difficulty).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Visual Feedback of 3D Digit Force', 'description': "The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.\n\n3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions."}, {'id': 'FG001', 'title': 'Visual Feedback of 1D Digit Force', 'description': "The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.\n\n1D: Practice generating grip force to the target shown on the computer screen in 1 dimension."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Not meeting inclusion criteria (n=1) Declined to participate (n=3) Funding ended (n=2)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Visual Feedback of 3D Digit Force', 'description': "The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.\n\n3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions."}, {'id': 'BG001', 'title': 'Visual Feedback of 1D Digit Force', 'description': "The participant's voluntary grip force in 1 dimension will be shown to 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'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-23', 'size': 2585516, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-03T14:53', 'hasProtocol': True}, {'date': '2022-03-07', 'size': 1489676, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-21T12:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2019-06-19', 'resultsFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-21', 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Box and Block Test', 'timeFrame': 'baseline to within 1 week post intervention', 'description': 'a clinical assessment measuring the number of blocks that a person can move in a minute, with a higher score representing better upper extremity function'}, {'measure': 'Stroke Impact Scale Hand Subscale', 'timeFrame': 'baseline to within 1 week post intervention', 'description': 'Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).'}, {'measure': 'Action Research Arm Test', 'timeFrame': 'baseline to 1 month post intervention', 'description': 'change in a clinical assessment of Action Research Arm Test that is in a scale 0-57 with a higher score representing better upper extremity function'}, {'measure': 'Box and Block Test', 'timeFrame': 'baseline to 1 month post intervention', 'description': 'a clinical assessment for upper extremity function.'}, {'measure': 'Stroke Impact Scale Hand Subscale', 'timeFrame': 'baseline to 1 month post intervention', 'description': 'Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).'}], 'primaryOutcomes': [{'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': 'baseline to within 1 week post intervention', 'description': 'change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hand Strength', 'Electromyography'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '40401398', 'type': 'DERIVED', 'citation': 'Seo NJ, Schranz C, Coupland K, Blaschke J, Scronce G, Finetto C, Baker A, Gallant J, Alston A, Howard K, Thompson D, Ramakrishnan V, Holmstedt CA, Kamper DG. Biofeedback Training for 3-Dimensional Finger Force Control to Improve Upper Limb Function Poststroke: An RCT. Stroke. 2025 Aug;56(8):2266-2276. doi: 10.1161/STROKEAHA.125.050965. Epub 2025 May 22.'}, {'pmid': '35413931', 'type': 'DERIVED', 'citation': 'Seo NJ, Kamper DG, Ramakrishnan V, Harvey JB, Finetto C, Schranz C, Scronce G, Coupland K, Howard K, Blaschke J, Baker A, Meinzer C, Velozo CA, Adams RJ. Effect of novel training to normalize altered finger force direction post-stroke: study protocol for a double-blind randomized controlled trial. Trials. 2022 Apr 12;23(1):301. doi: 10.1186/s13063-022-06224-w.'}]}, 'descriptionModule': {'briefSummary': "Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.", 'detailedDescription': "Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.\n\nStroke survivors with moderate to severe hand impairment with at least palpable volitional grip force will randomly be assigned to either the experimental or control group, stratified by impairment level. Both groups will undergo 3 1-hr training sessions per week for 6 weeks in which they practice volitional finger force generation against force sensors. The experimental group will practice for various target force directions to explore the 3D force workspace and receive feedback in 3D force, while the control group will practice 1D force generation without feedback on other directional forces on a computer screen.\n\nTraining will progress by increasing influence of flexion synergy by varying posture requirements and increasing force level, introducing feedback delay, and incorporating unilateral/bilateral activity. Evaluation will occur at baseline (3 times over 3 weeks to establish baseline trends) and every 2 weeks during 6-week intervention to determine pattern of progress, and at 1-month follow-up to assess retention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Survived a stroke at least 3 months ago\n* Moderate to severe hand impairment (Chedoke-McMaster Hand Stage 2-4)\n* Ability to generate palpable volitional grip force upon cue\n* Sufficient cognitive ability to participate (NIH Stroke Scale, NIHSS, Questions and Commands score = 0-1)\n* Ability to recognize all quadrants of the visual field (NIHSS Visual Field Test score = 0)\n\nExclusion Criteria:\n\n* Concurrent upper limb rehabilitation\n* Inability to follow 2-step commands\n* Severe muscle tone prohibiting passive movement of the fingers or proper placement of the fingers on the force sensors as needed to participate in the training (Modified Ashworth Scale=4-5 out of 5)\n* Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment\n* Total sensory loss on fingertips (NIHSS Sensory score=2)\n* Comorbidity (e.g., orthopaedic conditions that limit ranges of motion, premorbid neurologic conditions)\n* Language barrier or cognitive impairment that precludes providing consent'}, 'identificationModule': {'nctId': 'NCT03995069', 'acronym': 'NEAD', 'briefTitle': 'Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke', 'nctIdAliases': ['NCT03993756'], 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke', 'orgStudyIdInfo': {'id': 'A3066-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D', 'description': "The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.", 'interventionNames': ['Behavioral: 3D']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1D', 'description': "The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.", 'interventionNames': ['Behavioral: 1D']}], 'interventions': [{'name': '3D', 'type': 'BEHAVIORAL', 'description': 'Practice generating grip force to the target shown on the computer screen in 3 dimensions.', 'armGroupLabels': ['3D']}, {'name': '1D', 'type': 'BEHAVIORAL', 'description': 'Practice generating grip force to the target shown on the computer screen in 1 dimension.', 'armGroupLabels': ['1D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29401-5703', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center, Charleston, SC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Na Jin Seo, PhD MS BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, SC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'During the study period and 5 years post study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual data will be shared as a supplement of a publication in peer reviewed journals if allowed by the journal, and also upon written request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}