Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT02762058
Status:
UNKNOWN
Last Update Posted:
2016-05-04
First Post:
2016-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088762', 'term': 'Mirror Movement Therapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-03', 'studyFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Average Response Time', 'timeFrame': '6-weeks', 'description': 'Mean average response time to complete tasks measured in seconds.'}], 'primaryOutcomes': [{'measure': 'Upper Extremity Function', 'timeFrame': '6-weeks', 'description': 'To measure subjects upper extremity function via assessment scores pre and post treatment.'}], 'secondaryOutcomes': [{'measure': 'Upper Extremity Range of Motion', 'timeFrame': '6-weeks', 'description': 'Arm position data recorded through the VR systems measured in millimeters.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acquired Brain Injury', 'Stroke Rehabilitation'], 'conditions': ['Acquired Brain Injury Including Stroke']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to investigate the effects of virtual reality based mirror therapy (VMT) on individuals with acquired brain injury when compared to a control group receiving traditional mirror therapy (TMT). This is a randomized controlled pilot study in which patients with hemiplegia will be assigned to VMT or TMT and the impact on upper extremity function will be observed.', 'detailedDescription': 'The investigators are currently running a mirror therapy pilot project in the Hamilton Health Sciences Rehabilitation Program. Mirror therapy has been successfully used with people that have injuries such as strokes or other types of brain injuries that affect movement on one side of their body. Mirror therapy involves placing a mirror over the affected limb and angling it to reflect the unaffected limb. This creates a visual illusion that moving the unaffected limb also results in movement in the affected limb. This is theorized to aid recovery of the motor system in the brain. Virtual Reality (VR) can also be used with people with strokes and brain injuries and many studies of VR have shown positive results. In this study, the investigators will combine VR and mirror therapy. The investigators have designed a special new system that uses VR headset to make it appear that both limbs are moving when only the unaffected limb is moving. The investigators are going to do this by having people complete virtual tasks wearing this specially programmed headset. The tasks are everyday activities that a person might perform using two hands. Ultimately, the investigators hope to determine whether there is any difference between VR mirror therapy and regular mirror therapy in improving upper limb function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of stroke or brain injury, including ischemic or hemorrhagic strokes, confirmed by radio logical evidence and evidence suggesting injury primarily to one side and exhibited by hemiplegia\n* their post injury time is between 2 weeks and 2 years\n* patients are between the age of 16 and 65 years old\n\nExclusion Criteria:\n\n* greater than stage 4 on the CMSA\n* behavioral impairments that may prevent safe or consistent participation'}, 'identificationModule': {'nctId': 'NCT02762058', 'briefTitle': 'Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study', 'orgStudyIdInfo': {'id': '1227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Patients receiving Virtual Reality Mirror Therapy', 'interventionNames': ['Device: Virtual Reality Mirror Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Patients receiving Traditional Mirror Therapy', 'interventionNames': ['Procedure: Traditional Mirror Therapy']}], 'interventions': [{'name': 'Virtual Reality Mirror Therapy', 'type': 'DEVICE', 'otherNames': ['VMT', 'Occulus Rift', 'Microsoft Kinect'], 'description': 'Virtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Traditional Mirror Therapy', 'type': 'PROCEDURE', 'otherNames': ['Mirror Therapy'], 'description': 'Traditional Mirror Therapy system consisting of a mirror in which patients view their healthy limb over the affected to trick brain during dual motion tasks. This therapy has been shown to improve upper extremity function in patients with acquired brain injury.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Denise Johnson, BHSc(PT)', 'role': 'CONTACT', 'email': 'johnsden@hhsc.ca', 'phone': '(905)521-2100'}, {'name': 'Bonnie Buchko', 'role': 'CONTACT', 'email': 'buchkbon@hhsc.ca', 'phone': '(905)521-2100'}], 'overallOfficials': [{'name': 'Hussein Abdullah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, {'name': 'Natural Sciences and Engineering Research Council, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Masters Student', 'investigatorFullName': 'Laura MacNeil', 'investigatorAffiliation': 'University of Guelph'}}}}