Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05856669
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2023-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2023-04-16', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in upper extremity active range of motion', 'timeFrame': '6 weeks', 'description': 'Measured via goniometer'}, {'measure': 'Change in grip strength', 'timeFrame': '6 weeks', 'description': 'Measured via hand dynamometer'}], 'secondaryOutcomes': [{'measure': 'Change in aerobic fitness', 'timeFrame': '6 weeks', 'description': 'Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Hemiparesis']}, 'referencesModule': {'references': [{'pmid': '25206611', 'type': 'RESULT', 'citation': 'Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.'}, {'pmid': '32671578', 'type': 'RESULT', 'citation': 'Mekbib DB, Zhao Z, Wang J, Xu B, Zhang L, Cheng R, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Ye X, Zhang J, Xu D. Proactive Motor Functional Recovery Following Immersive Virtual Reality-Based Limb Mirroring Therapy in Patients with Subacute Stroke. Neurotherapeutics. 2020 Oct;17(4):1919-1930. doi: 10.1007/s13311-020-00882-x.'}, {'pmid': '24080372', 'type': 'RESULT', 'citation': 'Modrono C, Navarrete G, Rodriguez-Hernandez AF, Gonzalez-Mora JL. Activation of the human mirror neuron system during the observation of the manipulation of virtual tools in the absence of a visible effector limb. Neurosci Lett. 2013 Oct 25;555:220-4. doi: 10.1016/j.neulet.2013.09.044. Epub 2013 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system.\n\nParticipants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported diagnosis of stroke\n* Greater than 2 years post-stroke\n* Access to reliable transportation\n* History of weakness/hemiparesis of one upper limb\n\nExclusion Criteria:\n\n* Significant vision impairment or blindness\n* Non-English speaking\n* History of seizure or seizure disorder\n* Health conditions which would be exacerbated by low-intensity exercise\n* Inability to use arms independently for exercise'}, 'identificationModule': {'nctId': 'NCT05856669', 'briefTitle': 'The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke', 'orgStudyIdInfo': {'id': 'IRB-300010445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single subject case study', 'interventionNames': ['Device: Virtual reality gaming']}], 'interventions': [{'name': 'Virtual reality gaming', 'type': 'DEVICE', 'description': "This study aims to combine the motivational delivery of therapy which is an immersive virtual reality with the foundational concepts of mirror therapy. By utilizing a recalibration software, the participant will be able to achieve magnified movements on their screen as compared to the limited movement that is occurring in reality. The recalibration software takes each plane of movement of the gaming controller and magnifies the participant's range of motion in order to promote greater participation and success in the game that they are playing (Walkin VR). By using the fundamental concepts of mirror therapy in an immersive virtual reality setting, the investigators aim to mimic the results of mirror therapy while increasing motivation and adherence to the therapeutic program to increase overall upper extremity function.", 'armGroupLabels': ['Single subject case study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Lakeshore Foundation Research Collaborative', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Jason Vice, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jason Eugene Vice', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}