Chronic StrokeNCT05907473
The Effect of Virtual Reality Therapy on Balance and Knee Control in Stroke Patients
A study testing Virtual Reality Therapy and Conventional Rehabilitation in people with Chronic Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of study is to determine whether the Virtual Reality training applied in addition to the exercises given inside and outside the parallel bar is effective on balance, daily living activities and knee control in stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Virtual Reality Therapy and Conventional Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2023to 15 Mar 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-70
- Having a stroke for the first time
- Patients who can stand and walk independently
Who cannot join
- Having neglect syndrome
- Being bilaterally affected
- Botulinum toxin application in the last three months
- Having additional neurological diseases such as Parkinson's, multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Therapy Applied in Addition to Conventional Balance Training on Balance and Knee Control in Stroke Patients
The aim of study is to determine whether the Virtual Reality training applied in addition to the exercises given inside and outside the parallel bar is effective on balance, daily living activities and knee control in stroke patients.
The hypotheses of the study are:
Read more
Hypothesis 1:
H0: Virtual reality training has no effect on balance in stroke patients. H1: Virtual reality training has an effect on balance in stroke patients.
Hypothesis 2; H0: Virtual reality training has no effect on activities of daily living in stroke patients.
H1: Virtual reality training has an effect on daily living activities in stroke patients.
Hypothesis 3; H0: Virtual reality training has no effect on knee control in stroke patients. H1: Virtual reality training has an effect on knee control in stroke patients
Read the detailed description
In recent years, virtual reality systems are widely preferred technology-assisted rehabilitation methods due to the many advantages they provide in stroke rehabilitation. Virtual reality increases the quality of movement and functional capacity both by providing a sensory environment and by motor learning.
- Conditions
- Chronic Stroke
- Being tested
- Virtual Reality Therapy, Conventional Rehabilitation
- Keywords
- Virtual Reality, Stroke, Knee Hyperextension, Gait Analysis, Activities of Daily Living, Balance
- 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 TherapyOther
Patients in this group will play balance-based games with the Virtual Reality System.
Conventional RehabilitationOther
In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation Group | Experimental | In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday. Receives: Other: Conventional Rehabilitation |
| Virtual Reality Therapy Group | Experimental | The patients in this group will be able to play balance-based games with the Virtual Reality System for 20 minutes, 3 days a week, together with the conventional rehabilitation program. Receives: Other: Virtual Reality Therapy; Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Gait Assessment System (Zebris Rehawalk)
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
Measured: Baseline
Computerized Gait Assessment System (Zebris Rehawalk)
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
Measured: 6.week (at the end of the training)
Barthel Index
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
Measured: Baseline
Barthel Index
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
Measured: 6.week (at the end of the training)
Functional Reach Test
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
Measured: Baseline
Functional Reach Test
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
Measured: 6.week (at the end of the training)
Timed Up and Go Test
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
Measured: Baseline
Timed Up and Go Test
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
Measured: 6.week (at the end of the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start16 May 2023
- Primary completion1 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Korkusuz, Hacettepe University
- Investigators
- Özlem Yürük, Prof.Dr., Study chair, Baskent UniversitySüleyman Korkusuz, MSc, Principal investigator, Atılım UniversityGülşen Taşkın, Assist.Prof, Study chair, Afyonkarahisar Sağlık Bilimleri UniversityMelike Sümeyye Cengiz, MSc, Study chair, Bandırma Onyedi Eylül UniversityBüşra Seçkinoğulları, MSc, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907473
- Sponsor's protocol ID
- 2023-77
- Status last verified
- Mar 2024
- First submitted
- 24 May 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palacios-Navarro G, Garcia-Magarino I, Ramos-Lorente P. A Kinect-Based System for Lower Limb Rehabilitation in Parkinson's Disease Patients: a Pilot Study. J Med Syst. 2015 Sep;39(9):103. doi: 10.1007/s10916-015-0289-0. Epub 2015 Aug 12.
PubMed 26265237Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.
PubMed 28606661Korkusuz S, Taskin G, Korkusuz BS, Ozen MS, Yuruk ZO. Examining the effects of non-immersive virtual reality game-based training on knee hyperextension control and balance in chronic stroke patients: a single-blind randomized controlled study. Neurol Sci. 2025 Mar;46(3):1267-1275. doi: 10.1007/s10072-024-07830-z. Epub 2024 Oct 28.
PubMed 39466327
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Therapy Applied in Addition to Conventional Balance Training on Balance and Knee Control in Stroke Patients
- ClinicalTrials.gov ID
- NCT05907473
- Acronym / sponsor ID
- 2023-77
- Conditions
- Chronic Stroke
- Keywords
- Virtual Reality, Stroke, Knee Hyperextension, Gait Analysis, Activities of Daily Living, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 18 Jun 2023 (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.
The aim of study is to determine whether the Virtual Reality training applied in addition to the exercises given inside and outside the parallel bar is effective on balance, daily living activities and knee control in stroke patients.
The hypotheses of the study are:
Hypothesis 1:
H0: Virtual reality training has no effect on balance in stroke patients. H1: Virtual reality training has an effect on balance in stroke patients.
Hypothesis 2; H0: Virtual reality training has no effect on activities of daily living in stroke patients.
H1: Virtual reality training has an effect on daily living activities in stroke patients.
Hypothesis 3; H0: Virtual reality training has no effect on knee control in stroke patients. H1: Virtual reality training has an effect on knee control in stroke patients
Detailed description
In recent years, virtual reality systems are widely preferred technology-assisted rehabilitation methods due to the many advantages they provide in stroke rehabilitation. Virtual reality increases the quality of movement and functional capacity both by providing a sensory environment and by motor learning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation Group | Experimental | Other: Conventional RehabilitationIn the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday. |
| Virtual Reality Therapy Group | Experimental | Other: Virtual Reality Therapy, Other: Conventional RehabilitationThe patients in this group will be able to play balance-based games with the Virtual Reality System for 20 minutes, 3 days a week, together with the conventional rehabilitation program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-70
- Having a stroke for the first time
- Patients who can stand and walk independently
Key exclusion criteria (4 listed)
- Having neglect syndrome
- Being bilaterally affected
- Botulinum toxin application in the last three months
- Having additional neurological diseases such as Parkinson's, multiple sclerosis
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 TherapyPatients in this group will play balance-based games with the Virtual Reality System. | Other | Virtual Reality Therapy Group |
| Conventional RehabilitationIn the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday. | Other | Conventional Rehabilitation Group, Virtual Reality Therapy Group |
Primary outcome
Computerized Gait Assessment System (Zebris Rehawalk)
Time frame: Baseline
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
Computerized Gait Assessment System (Zebris Rehawalk)
Time frame: 6.week (at the end of the training)
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
Barthel Index
Time frame: Baseline
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
Barthel Index
Time frame: 6.week (at the end of the training)
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
Functional Reach Test
Time frame: Baseline
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
Functional Reach Test
Time frame: 6.week (at the end of the training)
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
Timed Up and Go Test
Time frame: Baseline
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
Timed Up and Go Test
Time frame: 6.week (at the end of the training)
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
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 2 Apr 2024.
- Background: PubMed 26265237Palacios-Navarro G, Garcia-Magarino I, Ramos-Lorente P. A Kinect-Based System for Lower Limb Rehabilitation in Parkinson's Disease Patients: a Pilot Study. J Med Syst. 2015 Sep;39(9):103. doi: 10.1007/s10916-015-0289-0. Epub 2015 Aug 12.
- Background: PubMed 28606661Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.
- Derived from this study: PubMed 39466327Korkusuz S, Taskin G, Korkusuz BS, Ozen MS, Yuruk ZO. Examining the effects of non-immersive virtual reality game-based training on knee hyperextension control and balance in chronic stroke patients: a single-blind randomized controlled study. Neurol Sci. 2025 Mar;46(3):1267-1275. doi: 10.1007/s10072-024-07830-z. Epub 2024 Oct 28.
- Individual participant dataSharing planned: No
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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.
Özlem Yürük, Prof.Dr. study chair
Baskent University
Süleyman Korkusuz, MSc principal investigator
Atılım University
Gülşen Taşkın, Assist.Prof study chair
Afyonkarahisar Sağlık Bilimleri University
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 Therapy and Conventional Rehabilitation in people with Chronic Stroke, run by Hacettepe 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 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 2 Apr 2024. 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?
Computerized Gait Assessment System (Zebris Rehawalk) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907473, which also lists 3 linked publications.
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 2 Apr 2024.