Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:20 AM
Study NCT ID:
NCT07431151
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Subacute Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Time Frame: Baseline only (screening measure)', 'description': 'The MoCA is a 30-point cognitive screening tool assessing visuospatial abilities, executive function, memory, attention, language, and orientation. Higher scores indicate better cognitive function.'}], 'primaryOutcomes': [{'measure': 'Timed Up and Go Test (TUG)', 'timeFrame': 'Baseline and immediately after completion of the 15-session intervention period (15 days)', 'description': 'The Timed Up and Go Test measures functional mobility. Participants are instructed to stand up from a standard chair (approximately 46 cm height), walk 3 meters at a comfortable and safe pace, turn around, walk back, and sit down. The total time required to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility.'}, {'measure': 'Canadian Occupational Performance Measure (COPM)', 'timeFrame': 'Baseline and post-intervention (15 days)', 'description': 'The COPM is a client-centered outcome measure assessing perceived performance and satisfaction in self-care, productivity, and leisure activities. Participants rate identified priority activities on a 10-point scale for performance and satisfaction. Higher scores indicate better perceived performance and satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Activities-Specific Balance Confidence Scale (ABC)', 'timeFrame': 'Baseline and post-intervention (15 days)'}, {'measure': 'Stroke-Specific Quality of Life Scale (SS-QoL)', 'timeFrame': 'Baseline and post-intervention (15 days)', 'description': 'The Stroke-Specific Quality of Life Scale evaluates health-related quality of life across 12 domains including mobility, mood, self-care, upper extremity function, and social roles. Items are rated on a 5-point Likert scale. Higher scores indicate better quality of life.'}, {'measure': 'Functional Ambulation Category (FAC)', 'timeFrame': 'Baseline and post-intervention (15 days)', 'description': 'The FAC is a 6-level scale assessing walking independence based on the amount of physical support required. Higher scores indicate greater functional ambulation independence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'virtual reality', 'rehabilitation', 'c-mill', 'augmented reality'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is one of the leading causes of long-term disability worldwide, and balance and gait impairments are common in the subacute phase, limiting activity performance and quality of life. Early and intensive rehabilitation during the first six months after stroke is considered critical for optimizing functional recovery. Virtual reality-based rehabilitation has emerged as a promising approach to enhance motor learning through task-specific, repetitive, and feedback-driven training.\n\nThis randomized controlled trial aims to investigate the effects of intensive virtual reality-based balance and gait training on activity performance, balance confidence, and quality of life in individuals with subacute stroke. Participants will be randomly allocated to either an intervention group receiving conventional physiotherapy combined with additional virtual reality-based balance and gait training, or a control group receiving conventional physiotherapy alone during the study period. Outcome measures will include functional mobility, balance confidence, cognitive status, and stroke-specific quality of life. The findings of this study may contribute to optimizing rehabilitation intensity and timing strategies in subacute stroke rehabilitation', 'detailedDescription': 'Stroke is a leading cause of long-term disability worldwide. In the subacute phase, defined as the first six months after stroke, individuals frequently experience impaired balance, reduced gait adaptability, decreased activity performance, and diminished quality of life. Deficits in postural control and increased postural sway contribute to elevated fall risk and reduced community participation. Evidence suggests that the early post-stroke period represents a critical window for neuroplasticity, during which intensive and task-specific rehabilitation may significantly enhance motor recovery.\n\nVirtual reality (VR)-based rehabilitation has emerged as an innovative therapeutic modality that integrates repetitive, task-oriented training with enriched multisensory feedback. VR systems provide real-time visual and auditory feedback, increase patient engagement, and promote motor learning principles such as high repetition, progressive challenge, and goal-directed practice. Previous studies have demonstrated that VR-based gait and balance training may improve functional mobility and postural control in stroke survivors. However, the optimal timing and intensity of such interventions during the subacute phase remain insufficiently explored.\n\nThis randomized controlled trial is designed to investigate the effects of intensive VR-based balance and gait training on activity performance, balance confidence, functional mobility, and stroke-specific quality of life in individuals with subacute stroke. Participants who meet the eligibility criteria will be randomly assigned to one of two parallel groups using a computer-generated randomization sequence.\n\nAll participants will receive routine conventional physiotherapy consisting of one hour of standard rehabilitation per session. In addition, the intervention group will receive an extra 30-minute session of VR-based balance and gait training per treatment day. The VR program includes progressive weight-shifting tasks, stepping exercises, and gait-related activities delivered through immersive or semi-immersive systems. Training intensity will be progressively adjusted according to individual performance levels, ensuring task-specific and graded motor challenge. Safety harness systems providing body-weight support will be used during sessions to minimize fall risk.\n\nThe control group will continue to receive conventional physiotherapy alone during the study period and will receive VR-based training after completion of the waiting period to ensure ethical balance. Outcome assessments will be conducted by a blinded assessor in a dedicated laboratory setting.\n\nPrimary and secondary outcomes will include functional mobility (Timed Up and Go Test), balance confidence (Activities-specific Balance Confidence Scale), cognitive status (Montreal Cognitive Assessment), functional ambulation level (Functional Ambulation Category), activity performance (Canadian Occupational Performance Measure), and stroke-specific quality of life (Stroke-Specific Quality of Life Scale). Assessments will be performed at baseline and immediately after completion of the intervention period.\n\nThe results of this study are expected to provide evidence regarding the effectiveness of intensified VR-based rehabilitation during the subacute phase of stroke and may contribute to optimizing rehabilitation timing and dosage strategies in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Diagnosis of hemiplegia (ICD-10 code G81)\n* Age ≥ 18 years\n* Montreal Cognitive Assessment (MoCA) score \\> 10\n\nExclusion Criteria\n\n* Failure to attend three consecutive treatment sessions during the study period\n* Receiving additional balance- or gait-specific rehabilitation interventions (e.g., robot-assisted gait training) during the study period'}, 'identificationModule': {'nctId': 'NCT07431151', 'briefTitle': 'Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Subacute Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'The Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Individuals With Subacute Stroke', 'orgStudyIdInfo': {'id': 'Stroke07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Experimental Group', 'description': 'Participants in the experimental group will receive routine conventional physiotherapy (60 minutes per session) combined with an additional 30 minutes of virtual reality-based balance and gait training per treatment day for a total of 15 sessions.\n\nThe VR intervention will include task-specific balance and gait activities such as weight shifting, stepping exercises, and progressive gait tasks delivered through immersive or semi-immersive virtual reality systems. Training intensity and task difficulty will be progressively adjusted according to individual performance levels. A body-weight support safety harness will be used during sessions to minimize fall risk.', 'interventionNames': ['Other: Virtual Reality-Based Balance and Gait Training', 'Other: Conventional Physiotherapy']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Participants in the control group will receive routine conventional physiotherapy (60 minutes per session) for 15 sessions during the study period. After completion of the study assessments, participants in this group will be offered virtual reality-based balance and gait training.', 'interventionNames': ['Other: Conventional Physiotherapy']}], 'interventions': [{'name': 'Virtual Reality-Based Balance and Gait Training', 'type': 'OTHER', 'description': 'Participants will receive an additional 30-minute session of virtual reality-based balance and gait training per treatment day for a total of 15 sessions, alongside routine conventional physiotherapy. The VR program will include task-specific exercises targeting balance and walking, such as weight-shifting, stepping, and gait-related tasks selected from a pre-defined exercise pool and individualized according to participant needs. Task difficulty will be progressed within and across sessions based on performance. Active exercise time will be recorded; rest periods due to fatigue will not be counted as active training time. A safety harness providing body-weight support will be used during training to minimize fall risk.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Conventional Physiotherapy', 'type': 'OTHER', 'description': 'Participants will receive routine conventional physiotherapy consisting of 60 minutes per session for a total of 15 sessions. The program will be delivered as part of standard inpatient/outpatient physiotherapy care and will include conventional rehabilitation components aimed at improving balance, mobility, and functional capacity, as clinically indicated.', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Çankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Murat Akıncı', 'role': 'CONTACT', 'email': 'muratakinci.fzt@gmail.com', 'phone': '05529356978'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Murat Akıncı', 'role': 'CONTACT', 'email': 'muratakinci.fzt@gmail.com', 'phone': '+905529356978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Murat Akıncı', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}