StrokeNCT07431151
Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Subacute Stroke Patients
A study testing Virtual Reality-Based Balance and Gait Training and Conventional Physiotherapy in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality-Based Balance and Gait Training and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hemiplegia (ICD-10 code G81)
- Age ≥ 18 years
- Montreal Cognitive Assessment (MoCA) score > 10
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
Murat Akıncı, 05529356978, muratakinci.fzt@gmail.com
About this study
Official title: The Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Individuals With Subacute Stroke
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
Read the 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.
- Conditions
- Stroke
- Being tested
- Virtual Reality-Based Balance and Gait Training, Conventional Physiotherapy
- Keywords
- stroke, virtual reality, rehabilitation, c-mill, augmented reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Balance and Gait TrainingOther
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.
Conventional PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Based Balance and Gait Training + Conventional Physiotherapy | Other | 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.
The 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. Receives: Other: Virtual Reality-Based Balance and Gait Training; Other: Conventional Physiotherapy |
| Conventional Physiotherapy | Other | 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the 15-session intervention period (15 days)
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.
Measured: Baseline and post-intervention (15 days)
Secondary outcomes (3)
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.
Measured: Baseline and post-intervention (15 days)
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.
Measured: Baseline and post-intervention (15 days)
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.
Measured: Baseline and post-intervention (15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Akıncı, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431151
- Sponsor's protocol ID
- Stroke07
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intensive Virtual Reality-Based Balance and Gait Training on Activity Performance and Quality of Life in Individuals With Subacute Stroke
- ClinicalTrials.gov ID
- NCT07431151
- Acronym / sponsor ID
- Stroke07
- Conditions
- Stroke
- Keywords
- stroke, virtual reality, rehabilitation, c-mill, augmented reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Based Balance and Gait Training + Conventional Physiotherapy | Other | Other: Virtual Reality-Based Balance and Gait Training, Other: Conventional PhysiotherapyParticipants 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. The 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. |
| Conventional Physiotherapy | Other | Other: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of hemiplegia (ICD-10 code G81)
- Age ≥ 18 years
- Montreal Cognitive Assessment (MoCA) score > 10
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Based Balance and Gait TrainingParticipants 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. | Other | Virtual Reality-Based Balance and Gait Training + Conventional Physiotherapy |
| Conventional PhysiotherapyParticipants 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. | Other | Conventional Physiotherapy, Virtual Reality-Based Balance and Gait Training + Conventional Physiotherapy |
Primary outcome
Timed Up and Go Test
Time frame: 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
Time frame: 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.
3 secondary outcomes
Activities-Specific Balance Confidence Scale
Time frame: Baseline and post-intervention (15 days)
Stroke-Specific Quality of Life Scale
Time frame: Baseline and post-intervention (15 days)
Functional Ambulation Category
Time frame: Baseline and post-intervention (15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Balance and Gait Training and Conventional Physiotherapy in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat Akıncı (+905529356978, muratakinci.fzt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (time frame: Baseline and immediately after completion of the 15-session intervention period (15 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.