About this trial
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.
This 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of hemiplegia (ICD-10 code G81)
Age ≥ 18 years
Montreal Cognitive Assessment (MoCA) score > 10
Disqualifiers
Failure to attend three consecutive treatment sessions during the study period
Receiving additional balance- or gait-specific rehabilitation interventions (e.g., robot-assisted gait training) during the study period
Trial design
Parallel
Treatments tested in this trial
Virtual Reality-Based Balance and Gait Training
Other interventionParticipants 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.
Conventional Physiotherapy
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Timed Up and Go Test
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.
Canadian Occupational Performance Measure
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.
Secondary outcomes
Activities-Specific Balance Confidence Scale
The Activities-Specific Balance Confidence Scale is a 16-item, self-report clinical tool designed to measure an individual's self-efficacy or level of confidence in maintaining balance while performing specific activities of daily living without falling.
Stroke-Specific Quality of Life Scale
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.
Functional Ambulation Category
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.
Other outcomes
Montreal Cognitive Assessment
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.
Sponsors and contacts
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Ankara Yildirim Beyazıt University
Lead sponsor
Ankara City Hospital Bilkent
Sponsor institution