HemiplegiaNCT06244459
Virtual Reality Mediated Functional Status Assessment in Stroke Patients
A study testing VR Assessment Tool in people with Hemiplegia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the applicability of virtual reality-mediated functional status assessment of patients diagnosed with stroke. Remote assessment of patients and remote rehabilitation (tele-rehabilitation) has an increasing application area in individuals with chronic neurological diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- VR Assessment Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between the ages of 18-65,
- History of stroke
- Accept to participate in the study,
Who cannot join
- Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurological deficit,
- Uncontrolled hypertension, diabetes, cardiovascular disease etc.
- Cognitive impairment causing difficulty in performing simple commands
- Epilepsy
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the applicability of virtual reality-mediated functional status assessment of patients diagnosed with stroke. Remote assessment of patients and remote rehabilitation (tele-rehabilitation) has an increasing application area in individuals with chronic neurological diseases. In this study, it was aimed to evaluate the upper extremity and balance functions of stroke patients with the developed software.
Read the detailed description
This prospective and descriptive study will be conducted with patients diagnosed with stroke. Patients diagnosed with stroke will first be evaluated by an expert physiatrist in a clinical setting to determine their functional status, and then evaluated by a virtual reality mediated software system. The evaluation of a patient will take approximately 1 hour.
Participants diagnosed with stroke will be evaluated in terms of hand and balance functions. The measurement parameters planned to be performed are scales routinely applied in stroke patients. Hand functions of the users will be evaluated with the 'Wooden Box and Block Test' , lower extremity muscle strength and fall risk will be evaluated with the 'Sit and Stand Test for 5 Times', and balance functions will be evaluated with the '360 Degree Rotation Test' . The tests mentioned above will be presented to the users first in the real world and then in the virtual reality environment and an objective functional status assessment will be made.
A total of 30 patients diagnosed with stroke are planned to be included in the study.
- Conditions
- Hemiplegia
- Being tested
- VR Assessment Tool
- Keywords
- virtual reality, assessment
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Assessment ToolOther
Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegia Group | Experimental | Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality. Receives: Other: VR Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test
The Box and Block Test measures unilateral gross manual dexterity. It is calculated how many cubes the patient moves between the compartments in 1 minute with both hands separately.
Measured: 1 day
360 degree rotation test
It is a useful and practical test to evaluate the balance functions of patients. It is calculated how many seconds it takes the patient to complete one full round.
Measured: 1 day
5 times Squat Test
It is performed to evaluate the balance and lower extremity functions of the patients, and the number of seconds it takes to squat 5 times is calculated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 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 HemiplegiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Kivanc Menekseoglu, Istanbul University
- Investigators
- Ahmet Menekseoglu, MD, Principal investigator, Kanuni Sultan Suleyman Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244459
- Sponsor's protocol ID
- KAEK/2022.11.222
- Status last verified
- Apr 2025
- First submitted
- 20 Jan 2024
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data obtained as a result of the study will be used within the scope of academic study by protecting the personal information of the participants.
Publications
Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
PubMed 3160243Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.
PubMed 20298832Dite W, Temple VA. Development of a clinical measure of turning for older adults. Am J Phys Med Rehabil. 2002 Nov;81(11):857-66; quiz 867-8. doi: 10.1097/00002060-200211000-00010.
PubMed 12394998
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Mediated Functional Status Assessment in Stroke Patients
- ClinicalTrials.gov ID
- NCT06244459
- Acronym / sponsor ID
- KAEK/2022.11.222
- Conditions
- Hemiplegia
- Keywords
- virtual reality, assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 Feb 2024 (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 the study is to investigate the applicability of virtual reality-mediated functional status assessment of patients diagnosed with stroke. Remote assessment of patients and remote rehabilitation (tele-rehabilitation) has an increasing application area in individuals with chronic neurological diseases. In this study, it was aimed to evaluate the upper extremity and balance functions of stroke patients with the developed software.
Detailed description
This prospective and descriptive study will be conducted with patients diagnosed with stroke. Patients diagnosed with stroke will first be evaluated by an expert physiatrist in a clinical setting to determine their functional status, and then evaluated by a virtual reality mediated software system. The evaluation of a patient will take approximately 1 hour.
Participants diagnosed with stroke will be evaluated in terms of hand and balance functions. The measurement parameters planned to be performed are scales routinely applied in stroke patients. Hand functions of the users will be evaluated with the 'Wooden Box and Block Test' , lower extremity muscle strength and fall risk will be evaluated with the 'Sit and Stand Test for 5 Times', and balance functions will be evaluated with the '360 Degree Rotation Test' . The tests mentioned above will be presented to the users first in the real world and then in the virtual reality environment and an objective functional status assessment will be made.
A total of 30 patients diagnosed with stroke are planned to be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality.
| Arm | Type | Receives |
|---|---|---|
| Hemiplegia Group | Experimental | Other: VR Assessment ToolParticipants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be between the ages of 18-65,
- History of stroke
- Accept to participate in the study,
Key exclusion criteria (5 listed)
- Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurological deficit,
- Uncontrolled hypertension, diabetes, cardiovascular disease etc.
- Cognitive impairment causing difficulty in performing simple commands
- Epilepsy
- Pregnancy.
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 Assessment ToolParticipants diagnosed with stroke will be evaluated with the Box and Block Test, 360 degree rotation test and 5 times squat test. These tests will be presented to the participants first in the real world and then in virtual reality. | Other | Hemiplegia Group |
Primary outcome
Box and Block Test
Time frame: 1 day
The Box and Block Test measures unilateral gross manual dexterity. It is calculated how many cubes the patient moves between the compartments in 1 minute with both hands separately.
360 degree rotation test
Time frame: 1 day
It is a useful and practical test to evaluate the balance functions of patients. It is calculated how many seconds it takes the patient to complete one full round.
5 times Squat Test
Time frame: 1 day
It is performed to evaluate the balance and lower extremity functions of the patients, and the number of seconds it takes to squat 5 times is calculated.
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 20 Apr 2025.
- Results publication: PubMed 3160243Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
- Results publication: PubMed 20298832Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.
- Results publication: PubMed 12394998Dite W, Temple VA. Development of a clinical measure of turning for older adults. Am J Phys Med Rehabil. 2002 Nov;81(11):857-66; quiz 867-8. doi: 10.1097/00002060-200211000-00010.
- Individual participant dataSharing planned: No. The data obtained as a result of the study will be used within the scope of academic study by protecting the personal information of the participants.
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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.
Ahmet Menekseoglu, MD principal investigator
Kanuni Sultan Suleyman Research and Training 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 Assessment Tool in people with Hemiplegia, run by Istanbul 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 5 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 20 Apr 2025. 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?
Box and Block Test (time frame: 1 day). The study lists 3 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 NCT06244459, 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 20 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.