Stroke
Conditions
Keywords
stroke, virtual reality, rehabilitation, c-mill, augmented reality
Brief summary
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
Detailed description
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. Virtual 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. This 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. All 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. The 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. Primary 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. The 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.
Interventions
OTHERVirtual Reality-Based Balance and Gait Training
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.
OTHERConventional Physiotherapy
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.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of hemiplegia (ICD-10 code G81) * Age ≥ 18 years * Montreal Cognitive Assessment (MoCA) score \> 10
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test | Baseline and immediately after completion of the 15-session intervention period (15 days) | 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 | Baseline and post-intervention (15 days) | 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
| Measure | Time frame | Description |
|---|---|---|
| Activities-Specific Balance Confidence Scale | Baseline and post-intervention (15 days) | 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 | Baseline and post-intervention (15 days) | 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 | Baseline and post-intervention (15 days) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMurat Akıncı
Outcome results
None listed