Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-11 @ 9:20 PM
Study NCT ID:
NCT03277950
Status:
UNKNOWN
Last Update Posted:
2017-09-11
First Post:
2017-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Game on Upper Limb Movement in Individuals With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020820', 'term': 'Dyskinesias'}], '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': 'D009069', 'term': 'Movement Disorders'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'kinematic data', 'timeFrame': '10 minutes', 'description': 'angle of shoulder, elbow, and forearm'}], 'secondaryOutcomes': [{'measure': 'Upper limb performance', 'timeFrame': '10 minutes', 'description': 'doing task according to Fugl Mayer'}, {'measure': 'muscle tone', 'timeFrame': '2 minutes', 'description': 'assessing muscles of shoulder, elbow, and forearm according to Modified Ashworth Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'feedback'], 'conditions': ['Stroke', 'Movement, Abnormal']}, 'descriptionModule': {'briefSummary': 'Individuals with stroke show abnormal movement pattern of upper limb. The movement pattern needs to be corrected. There are several methods to train normal movement. Exercise with technology is an active movement and affects sensory and cognitive systems. It may benefit to individuals with stroke in training.', 'detailedDescription': 'Individuals with stroke sign informed consent. They are trained with virtual reality game with and without feedback from a researcher. Age-matched healthy play the same game as individuals with stroke do. Both individuals with stroke and healthy are measured upper limb movement pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals with stroke\n\n1. 45 - 65 years old\n2. First ischemic or hemorrhagic stroke\n3. Right hemiparesis\n4. Right dominant handedness\n5. Within 6 months after stroke\n6. Discharge from hospital and stay at home\n7. Normal dynamic sitting balance\n8. At least 120 degrees of shoulder flexion and 45 degrees of shoulder extension by passive range of motion\n9. Active movement at least stage 3 by Chedoke-McMaster Stroke Assessment\n10. Muscle tone graded 1-2 by Modified Ashworth Scale in 2 of 3 muscle groups including shoulder adductor, internal rotator or/and elbow flexor groups\n11. No cognitive impairment\n\nHealthy individuals\n\n1. Have same gender and age within range of ±5 years of individuals with stroke\n2. Right handedness\n3. Active range of motion of shoulder flexion and extension at least 120°and 45° respectively\n4. No cognitive impairment\n\nExclusion Criteria:\n\nIndividual with stroke and healthy\n\n1. Have cyber-sickness\n2. Obesity\n3. Ataxic movement\n4. Loss visual field or visual neglect\n5. Loss exteroceptive sensation\n6. Impaired or loss proprioceptive sensation\n7. Receive the occupation therapy on upper extremity\n8. Muscle contracture at the scapula, shoulder and elbow\n9. Pain at the scapula, shoulder and elbow\n10. History of fracture or surgery at head, shoulder, scapula, and elbow\n11. Shoulder subluxation\n12. Other neurological disorders\n13. Uncontrolled hypertension\n14. Myocardial infarction\n15. Seizure or epilepsy\n16. Pacemaker or hemodialysis vascular access'}, 'identificationModule': {'nctId': 'NCT03277950', 'acronym': 'VRULS', 'briefTitle': 'Effect of Virtual Reality Game on Upper Limb Movement in Individuals With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effect of Game-based Virtual Reality Training on Upper Extremity Movement in Individuals With Subacute Stroke', 'orgStudyIdInfo': {'id': '2016/097.0906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality with feedback', 'description': 'Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.', 'interventionNames': ['Other: Virtual reality with feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'virtual reality without feedback', 'description': 'Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.', 'interventionNames': ['Other: Virtual reality without feedback']}, {'type': 'OTHER', 'label': 'Healthy', 'description': 'Participants do not play virtual reality game.', 'interventionNames': ['Other: Healthy']}], 'interventions': [{'name': 'Virtual reality with feedback', 'type': 'OTHER', 'description': 'Individuals with stroke play game with correction of movement.', 'armGroupLabels': ['virtual reality with feedback']}, {'name': 'Virtual reality without feedback', 'type': 'OTHER', 'description': 'Individuals with stroke play game without correction of movement.', 'armGroupLabels': ['virtual reality without feedback']}, {'name': 'Healthy', 'type': 'OTHER', 'description': 'Healthy do not play game', 'armGroupLabels': ['Healthy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vimonwan Hiengkaew, PhD', 'role': 'CONTACT', 'email': 'vimonwan.hie@mahidol.ac.th', 'phone': '+6624415450'}], 'overallOfficials': [{'name': 'Vimonwan Hiengkaew, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}, {'name': 'Peemonkong Wattananon, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mahidol University'}, {'name': 'Sirada Lolak, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vimonwan Hiengkaew', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Vimonwan Hiengkaew', 'investigatorAffiliation': 'Mahidol University'}}}}