Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-04 @ 8:23 PM
Study NCT ID:
NCT06495450
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Motivation of participant', 'timeFrame': '12 weeks (study completion)', 'description': 'The investigators will measure motivation by intrinsic motivation inventory. Higher scores indicate better results.'}, {'measure': 'Health-related quality of life of participant', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'The investigators will measure health-related quality of life by the Stroke Impact Scale-3.0. Higher scores indicate better results.'}], 'primaryOutcomes': [{'measure': 'Consent rate', 'timeFrame': 'Baseline', 'description': 'Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.'}, {'measure': 'Retention rate', 'timeFrame': '12 weeks (study completion)', 'description': 'Retention rate is the percentage of participants who complete the 12-week intervention. The investigators expect a retention rate of 80% for the intervention group.'}, {'measure': 'Usability of the Omnidirectional Treadmill and Virtual Reality Game', 'timeFrame': '12 weeks (study completion)', 'description': 'Usability will be assessed by System Usability Scale (SUS) out of 100 points. The investigators expect a SUS score of 71 or higher among all participants.'}, {'measure': 'Participant burden', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'Participant burden will be measured by the percentage of participants finishing assessments in 100 minutes or less. The investigators anticipate at least 85% of participants completing assessments within the time limit.'}, {'measure': 'Adherence', 'timeFrame': '12 weeks (study completion)', 'description': 'Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions.'}, {'measure': 'Equipment downtime', 'timeFrame': '12 weeks (study completion)', 'description': 'The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of sessions.'}, {'measure': 'Equipment safety', 'timeFrame': '12 weeks (study completion)', 'description': 'The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study'}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': "The investigators will use the Computerized MoCA \\[Montreal Cognitive Assessment\\] Duo to evaluate participants' cognitive function."}, {'measure': 'Executive Function', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': "The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function."}, {'measure': 'Working memory', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': "The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory."}, {'measure': 'Brain activation in prefrontal and premotor cortices', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'Brain activation using fNIRS \\[Functional near-infrared spectroscopy\\] in the prefrontal and premotor regions of interest during a single task (steady-state omnidirectional treadmill walking) and two cognitive-physical dual-task activities (simple dual-task: steady-state omnidirectional treadmill walking while repeating the same word and complex dual-task: steady-state omnidirectional treadmill walking while performing a verbal fluency test)'}, {'measure': 'Walking Speed', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'Walking speed using VIVE trackers on omnidirectional treadmill and overground'}, {'measure': 'Step cadence', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'The investigators will evaluate step cadence using the VIVE trackers.'}, {'measure': 'Step width', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'The investigators will evaluate step width using the VIVE trackers.'}, {'measure': 'Step length', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'The investigators will evaluate step length using the VIVE trackers.'}, {'measure': 'Dynamic balance', 'timeFrame': 'Baseline and 12 weeks (study completion)', 'description': 'The investigators will measure the static sway with feet together using omni-VR system and use MINI-BESTest to measure the dynamic balance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Stroke rehabilitation', 'Omnidirectional treadmill'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (consent rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes.\n\nResearchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors.\n\nParticipants will:\n\n* undergo a 45-minute training session 3 times per week for 12 weeks\n* intervention group: omni-VR\n* control group: traditional exercise program (strengthening and walking activities)', 'detailedDescription': "Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.\n\nVirtual reality or VR (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. It has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity.\n\nOmnidirectional treadmill technology can be integrated with VR to allow for fully immersive rehabilitation. This novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. However, no randomized trials have evaluated the impact of omnidirectional treadmill VR (Omni-VR) on cognitive and physical function among stroke survivors.\n\nTherefore, our study aims to test the feasibility and usability of the Omni-VR. This pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-VR system among chronic stroke survivors"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 18\n* Stroke ≥ 6 months ago (confirmed with chart review)\n* Living within 50 km of Halifax, Nova Scotia\n* Functional Ambulation Category of 3 or greater on a scale of 0-5, to ensure the participant is able to walk with supervision or independently. This criterion was selected to ensure participants could safely participate in the intervention.\n* Ability to participate in low-moderate intensity aerobic or strengthening exercise for ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45 minutes, with activity breaks, in keeping with previous stroke rehabilitation studies.\n* No uncorrected visual deficits or spatial neglect\n* No cardiovascular, orthopedic, or neurological diseases other than stroke impacting walking or balance\n* Can follow simple instructions\n* Score of \\< 27 on the adapted Motion Sickness Susceptibility Scale-Short based on established normative values indicating more than moderate susceptibility to motion sickness.\n\nExclusion Criteria:\n\n* Unstable serious medical condition\n* Resting blood pressure \\>180/100mmHg\n* History of abnormal untreated heart rhythm\n* Pregnancy\n* Condition limiting ability to complete or tolerate the exercises without major program modifications (e.g., chronic low back pain)\n* Serious comorbid condition that would affect participation in the intervention (e.g., active cancer, severe heart disease)\n* Severe loss of hearing or speech that would preclude VR use\n* Participant weight more than 264 lbs (weight limit for Virtualizer Elite 2 treadmill)\n* Participating in another formal lower limb exercise program \\> 1 day per week\n* History of QT prolongation or using potential QT prolonging drugs'}, 'identificationModule': {'nctId': 'NCT06495450', 'acronym': 'PROVE', 'briefTitle': 'Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'PROVE-VR: A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors', 'orgStudyIdInfo': {'id': 'PROVE_stroke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omni-VR group', 'description': '20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training.', 'interventionNames': ['Device: Omnidirectional Virtual Reality and Treadmill Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks.', 'interventionNames': ['Behavioral: Traditional Exercise']}], 'interventions': [{'name': 'Omnidirectional Virtual Reality and Treadmill Training', 'type': 'DEVICE', 'description': 'Omni-VR forest scenario developed by our team involving real-life dual task walking and dynamic balance activities (ie. stepping over obstacles, and managing distractions) will be used for treatment group.', 'armGroupLabels': ['Omni-VR group']}, {'name': 'Traditional Exercise', 'type': 'BEHAVIORAL', 'description': 'A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 4K4', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Adria Quigley, PhD', 'role': 'CONTACT', 'email': 'adriaquigley@dal.ca', 'phone': '902-494-2734'}], 'facility': 'Nova Scotia Rehabilitation & Arthritis Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'centralContacts': [{'name': 'Adria Quigley, PhD', 'role': 'CONTACT', 'email': 'adriaquigley@dal.ca', 'phone': '902-494-2734'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brain Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Adria Quigley', 'investigatorAffiliation': 'Dalhousie University'}}}}