StrokeNCT07475598
Virtual Reality-Based Balance Training in Hemiplegic Patients
A study testing VR-Based Balance Training and Routine Physical Therapy in people with Stroke and Hemiplegia, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective single-blind randomized controlled trial enrolled 43 hemiplegic patients hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- VR-Based Balance Training and Routine Physical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2024to 4 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-75
- Hemiplegic patients (ischemic/hemorrhagic) for 3-18 months
- No severe cognitive impairment, able to respond to visual and auditory commands
- Mini Mental Test (MMT) score of 24 or higher
- Ability to sit or stand independently
- Berg Balance Test (BBT) score of at least 21-56 points (patient group with moderate and/or low risk of falls)
Show all 11Show fewer
- Brunnstrom 1-2-3 (for paretic upper extremity)
- No history of non-paretic upper extremity fracture or amputation
- No condition that prevents exercise
- Individuals weighing less than 110 kg
- Each patient must be successful in at least 1 round in each game
Who cannot join
- Refusal to participate in the study or wishing to withdraw from the study
- Having communication problems such as speech and language problems
- Having advanced visual, vestibular or metabolic disorders that cause balance disorders
- Having other neurological diseases that cause gait disorders (Parkinson's, Multiple Sclerosis, Neuromuscular Diseases, Myelomalacia, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, YENIMAHALLE, 06170
About this study
Official title: Effects of Virtual Reality-Based Balance Games on Gait, Balance, and Quality of Life in Patients With Post-Stroke Hemiplegia: A Randomized Controlled Trial
This prospective single-blind randomized controlled trial enrolled 43 hemiplegic patients hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Participants were randomly assigned to a virtual reality (VR) group (n = 23), which received routine physical therapy combined with VR-based balance training, or a conventional therapy (CT) group (n = 20), which received routine physical therapy alone. Interventions were delivered under physiotherapist supervision over 20 sessions, with the VR group receiving an additional 12 sessions of VR-based balance exercises. Outcomes were assessed at baseline, immediately post-treatment, and at an eight-week follow-up, including measures of balance, mobility, functional independence, walking capacity, quality of life, and static balance using the Tecnobody PK252 isokinetic balance measurement system.
Read the detailed description
The study included 43 hemiplegic patients who met the inclusion criteria and were hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Patients were randomized into two groups using a sealed-envelope method: 23 patients were assigned to the VR group, which received conventional therapy combined with virtual reality-based balance games, and 20 patients were assigned to the CT group, which received only conventional therapy. The VR group received routine physical therapy and rehabilitation once daily for a total of 20 sessions, in addition to virtual reality-based balance games applied three times a week for 20 minutes per session, totaling 12 sessions, all under the supervision of a physiotherapist. The CT group received only routine physical therapy and rehabilitation once daily for a total of 20 sessions, also under the supervision of a physiotherapist. All patients were evaluated before treatment, at the end of treatment, and eight weeks after the end of treatment using the Berg Balance Test (BBT), Functional Reach Test (FRT), Timed Up and Go Test (TUG), Five Times Sit-to-Stand Test (5xSST), Functional Independence Measure (FIM), Six-Minute Walk Test (6MWT), Stroke-Specific Quality of Life Scale(SS-QOL), and static balance measurements obtained via the Tecnobody PK252 isokinetic balance measurement system.
- Conditions
- Stroke, Hemiplegia
- Being tested
- VR-Based Balance Training, Routine Physical Therapy
- Keywords
- Virtual Reality, Balance Training, Biofeedback, Hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Based Balance TrainingDevice
Participants receive routine physical therapy and rehabilitation once daily for 20 sessions, plus virtual reality-based balance exercises three times per week for 20 minutes per session (total 12 sessions), all under physiotherapist supervision.
Routine Physical TherapyBehavioural
Participants receive routine physical therapy and rehabilitation once daily for 20 sessions under physiotherapist supervision, without additional virtual reality-based balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | Participants receive routine physical therapy plus VR-based balance training. Receives: Device: VR-Based Balance Training |
| CT Group | Active comparator | Participants receive routine physical therapy only. Receives: Behavioral: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale Score
Balance performance assessed using the Berg Balance Scale, which includes 14 functional tasks scored from 0 to 4 with a total score ranging from 0 to 56. Higher scores indicate better balance.
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Secondary outcomes (7)
Functional Reach Test Distance
Maximum forward reach distance measured while maintaining a fixed base of support, used to assess dynamic balance and postural stability.
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Timed Up and Go Test Time
Time in seconds required for a participant to stand up from a chair, walk 3 meters, turn around, return, and sit down. Shorter times indicate better functional mobility and balance.
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Five Times Sit-to-Stand Test Time
Time in seconds required for a participant to stand up and sit down five consecutive times from a standard chair, assessing lower limb strength and functional mobility.
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Static Balance Score (Tecnobody PK252 Isokinetic Balance Measurement System)
The Technobody balance measurement system is typically used to assess static balance and balance limits in an upright position. A lower static balance assessment score indicates less body sway and better motor control and balance function in patients.
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Stroke-Specific Quality of Life Scale Score (SS-QOL)
The scale consists of 49 items in 12 domains. Each domain has at least 3 items. Each item is evaluated on a 5-point Likert scale, considering the past week. Higher scores indicate better functioning (energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper-extremity function, vision, work/productivity).
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Functional Independence Measure Total Score (FIM)
Functional independence assessed using the Functional Independence Measure (FIM), consisting of 18 items evaluating self-care, mobility, and cognition. Each item is scored from 1 (total assistance) to 7 (complete independence), with higher total scores indicating greater functional independence.
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Six-Minute Walk Test Distance (6MWT)
Walking endurance assessed by measuring the total distance a participant can walk on a flat surface in six minutes. Longer distances indicate better aerobic capacity and functional mobility.
Measured: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start24 Jan 2024
- Primary completion24 Apr 2025
- Study completion4 Aug 2025
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.
- 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
- Model description
- Patients were randomly assigned to two parallel groups: a VR group (n = 23) receiving routine physical therapy plus virtual reality-based balance training, and a CT group (n = 20) receiving routine physical therapy only. Interventions were delivered under physiotherapist supervision over 20 sessions, with the VR group receiving an additional 12 VR-based balance sessions. Outcomes, including balance, mobility, functional independence, walking capacity, quality of life, and static balance, were assessed at baseline, post-treatment, and eight-week follow-up using standardized clinical tests and the Tecnobody PK252 system.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Önoğul Özmen, Gaziantep City Hospital
- Investigators
- Ece ÜNLÜ AKYÜZ, Medical Doctor, Study director, Ankara Etlik City HospitalAslıhan UZUNKULAOĞLU, Medıcal Doctor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475598
- Sponsor's protocol ID
- AEŞH-BADEK-2024-059
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including balance, mobility, functional independence, walking endurance, and quality of life outcomes (BBT, FRT, TUG, 5xSTS, FIM, 6MWT, SS-QOL, and static balance measurements) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality-Based Balance Games on Gait, Balance, and Quality of Life in Patients With Post-Stroke Hemiplegia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07475598
- Acronym / sponsor ID
- AEŞH-BADEK-2024-059
- Conditions
- Stroke, Hemiplegia
- Keywords
- Virtual Reality, Balance Training, Biofeedback, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 16 Mar 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.
This prospective single-blind randomized controlled trial enrolled 43 hemiplegic patients hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Participants were randomly assigned to a virtual reality (VR) group (n = 23), which received routine physical therapy combined with VR-based balance training, or a conventional therapy (CT) group (n = 20), which received routine physical therapy alone. Interventions were delivered under physiotherapist supervision over 20 sessions, with the VR group receiving an additional 12 sessions of VR-based balance exercises. Outcomes were assessed at baseline, immediately post-treatment, and at an eight-week follow-up, including measures of balance, mobility, functional independence, walking capacity, quality of life, and static balance using the Tecnobody PK252 isokinetic balance measurement system.
Detailed description
The study included 43 hemiplegic patients who met the inclusion criteria and were hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Patients were randomized into two groups using a sealed-envelope method: 23 patients were assigned to the VR group, which received conventional therapy combined with virtual reality-based balance games, and 20 patients were assigned to the CT group, which received only conventional therapy. The VR group received routine physical therapy and rehabilitation once daily for a total of 20 sessions, in addition to virtual reality-based balance games applied three times a week for 20 minutes per session, totaling 12 sessions, all under the supervision of a physiotherapist. The CT group received only routine physical therapy and rehabilitation once daily for a total of 20 sessions, also under the supervision of a physiotherapist. All patients were evaluated before treatment, at the end of treatment, and eight weeks after the end of treatment using the Berg Balance Test (BBT), Functional Reach Test (FRT), Timed Up and Go Test (TUG), Five Times Sit-to-Stand Test (5xSST), Functional Independence Measure (FIM), Six-Minute Walk Test (6MWT), Stroke-Specific Quality of Life Scale(SS-QOL), and static balance measurements obtained via the Tecnobody PK252 isokinetic balance measurement system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to two parallel groups: a VR group (n = 23) receiving routine physical therapy plus virtual reality-based balance training, and a CT group (n = 20) receiving routine physical therapy only. Interventions were delivered under physiotherapist supervision over 20 sessions, with the VR group receiving an additional 12 VR-based balance sessions. Outcomes, including balance, mobility, functional independence, walking capacity, quality of life, and static balance, were assessed at baseline, post-treatment, and eight-week follow-up using standardized clinical tests and the Tecnobody PK252 system.
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Device: VR-Based Balance TrainingParticipants receive routine physical therapy plus VR-based balance training. |
| CT Group | Active comparator | Behavioral: Routine Physical TherapyParticipants receive routine physical therapy only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ages 18-75
- Hemiplegic patients (ischemic/hemorrhagic) for 3-18 months
- No severe cognitive impairment, able to respond to visual and auditory commands
- Mini Mental Test (MMT) score of 24 or higher
- Ability to sit or stand independently
Key exclusion criteria (4 listed)
- Refusal to participate in the study or wishing to withdraw from the study
- Having communication problems such as speech and language problems
- Having advanced visual, vestibular or metabolic disorders that cause balance disorders
- Having other neurological diseases that cause gait disorders (Parkinson's, Multiple Sclerosis, Neuromuscular Diseases, Myelomalacia, etc.)
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 |
|---|---|---|
| VR-Based Balance TrainingParticipants receive routine physical therapy and rehabilitation once daily for 20 sessions, plus virtual reality-based balance exercises three times per week for 20 minutes per session (total 12 sessions), all under physiotherapist supervision. | Device | VR Group |
| Routine Physical TherapyParticipants receive routine physical therapy and rehabilitation once daily for 20 sessions under physiotherapist supervision, without additional virtual reality-based balance exercises. | Behavioural | CT Group |
Primary outcome
Berg Balance Scale Score
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Balance performance assessed using the Berg Balance Scale, which includes 14 functional tasks scored from 0 to 4 with a total score ranging from 0 to 56. Higher scores indicate better balance.
7 secondary outcomes
Functional Reach Test Distance
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Timed Up and Go Test Time
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Five Times Sit-to-Stand Test Time
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Static Balance Score (Tecnobody PK252 Isokinetic Balance Measurement System)
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Stroke-Specific Quality of Life Scale Score (SS-QOL)
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Functional Independence Measure Total Score (FIM)
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Six-Minute Walk Test Distance (6MWT)
Time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data including balance, mobility, functional independence, walking endurance, and quality of life outcomes (BBT, FRT, TUG, 5xSTS, FIM, 6MWT, SS-QOL, and static balance measurements) will be shared.
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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. This study is not recruiting at the moment.
Ece ÜNLÜ AKYÜZ, Medical Doctor study director
Ankara Etlik City Hospital
Aslıhan UZUNKULAOĞLU, Medıcal Doctor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Based Balance Training and Routine Physical Therapy in people with Stroke and Hemiplegia, run by Gaziantep City Hospital 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 11 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale Score (time frame: Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment). 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 8 Jul 2026.