StrokeNCT07693413
Investigation of the Effects of Mixed Reality Application on the Upper Extremity in Individuals With Hemiparetic Stroke
A study testing Traditional therapy and virtual reality in people with Stroke, run by Emine Ece Bedir Ayar at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Traditional therapy and virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 30 May 2026
- 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
- Individuals aged 18-65 who have experienced a stroke.
- At least 6 months must have passed since the stroke.
- FIM independence scale score of 50 or higher.
- Fugl-Meyer Upper Extremity Assessment (FMA) score between 23-66.
- Mini Mental Test score above 24.
Who cannot join
- Presence of current epileptic seizures.
- Upper extremity spasticity 3-4.
- Visual or hearing loss that would affect the study.
- Individuals who have experienced multiple strokes.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu Univercity
Gaziantep, Gaziantep, 27000
About this study
Official title: Investigation of the Effects of Mixed Reality Application on Upper Extremity Motor Functions and Trunk Stability in Individuals With Hemiparetic Stroke
The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. The use of mixed reality technology in addition to traditional rehabilitation methods provides individuals with an interactive and motivating rehabilitation environment that mimics real-life activities. The study aims to increase functional independence, improve motor skills and trunk stability, enhance upper extremity functions, facilitate return to daily living activities, increase adaptation and motivation to the rehabilitation process, and provide a repeatable, safe, and patient-centered exercise environment in stroke patients. This thesis aims to contribute to both clinical physiotherapy practice and the literature by evaluating the applicability of mixed reality technology, a patient-centered and innovative rehabilitation approach, as a treatment option in neurological rehabilitation. The study's objective in improving upper extremity function is to make the individual less dependent on others while performing daily living activities, to instill a sense of self-sufficiency, and to enhance existing skills to make them more functional.
Read the detailed description
The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. The use of mixed reality technology in addition to traditional rehabilitation methods provides individuals with an interactive and motivating rehabilitation environment that mimics real-life activities. The population and sample of the study will consist of adult individuals with upper extremity functional limitations and stroke who are receiving treatment at the Gaziantep Metropolitan Municipality Accessible Living Center. The study will be divided into two groups, a study group and a control group, using stratified randomization. The study group will undergo upper extremity exercises using the Reach VR mixed reality application, while the control group will receive a conventional treatment program. This thesis aims to contribute to both clinical physiotherapy practice and the literature by evaluating the applicability of mixed reality technology, a patient-centered and innovative rehabilitation approach, as a treatment option in neurological rehabilitation. The aim of this study, which focuses on improving upper extremity function, is to make the individual less dependent on others for daily living activities, to instill a sense of self-sufficiency, and to enhance existing skills, thereby making them more functional.
- Conditions
- Stroke
- Being tested
- Traditional therapy, virtual reality
- Keywords
- stroke, rehabilitation, virtual reality, upper extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional therapyOther
The treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will receive traditional physiotherapy treatment, including upper extremity strengthening, motor skills exercises, and balance exercises.
virtual realityOther
The treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will be playing Reach VR within the Meta Quest 3 using the eye.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control group, receiving traditional treatment Receives: Other: Traditional therapy |
| Intervention group | Active comparator | Intervention group, receiving virtual reality treatment Receives: Other: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Box and Block Test - mBBT
The individual performs this test with both their dominant and non-dominant hand. mBBT reflects a direct assessment of individuals' upper extremity functional performance based on the number of blocks transferred from one compartment to the other within 30 seconds. At the end of the time period, the number of blocks transferred to the opposite compartment is recorded.
Measured: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
Secondary outcomes (6)
L-Shape Test
This test is applied to objectively measure safe walking and turning performance in individuals with lower extremity injuries or balance disorders. The test course is created on the ground in the shape of the letter L. A line is determined, usually consisting of 3 meters of straight walking from the starting point, followed by a 90-degree turn, and then approximately 7 meters of walking again. The corner of the course is the most critical part of the test in terms of evaluating the individual's ability to change direction. During the application, the individual is asked to proceed at a normal and safe walking speed from the starting point, turn at the corner, and complete the course. The test duration is recorded in seconds using a stopwatch.
Measured: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
Action Research Arm Test -ARAT
The test objectively assesses an individual's grasping, holding, carrying, and fine motor skills required for daily living activities. ARAT examines upper extremity function under four subheadings: Grasp, Grip, Pinch (Fine grip), and Gross Movement. The Grasp subtest evaluates the ability to grasp and carry blocks of varying sizes and shapes, while the Grip subtest examines the controlled grasping of smaller objects. Each item is scored between 0 and 3. The total score ranges from 0 to 57. A higher score indicates better upper extremity function.
Measured: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
İmpairment Scale - TIS
This scale provides important information about functional mobility by examining trunk stability and selective trunk movements in a seated position. It is evaluated out of a total of 17 points. Subtopics include static, dynamic sitting balance, and coordination.
Measured: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
BlazePod
This is a technology-based measurement and exercise system used to evaluate reaction time, upper and lower extremity function, balance, coordination, and cognitive-motor integration, particularly in stroke patients. Consisting of wireless, illuminated pod devices, this system quantitatively measures performance by assessing motor responses such as touching, reaching, or stepping in response to illuminated stimuli. It offers a more dynamic and task-oriented assessment compared to traditional clinical tests.
Measured: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
Specific Quality of Life Scale (SS-QOL)
It is widely used in rehabilitation to evaluate treatment effectiveness and monitor patient-centered outcomes. The SS-QOL consists of 12 sub-dimensions that assess stroke-specific quality of life. These sub-areas include energy, family roles, language, mobility, mood, personality, self-care, social roles, cognition, upper extremity function, vision, and work/productivity.
Measured: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
Client satisfaction Questionnaire - CSQ 8
The CSQ-8 provides important feedback in determining the client's perception and satisfaction with the treatment process. The CSQ-8 consists of 8 items, each questioning a different aspect of the service provided. The scale includes satisfaction indicators such as the quality of service received, the extent to which expectations are met, suitability to needs, benefit derived from the service, willingness to choose the same service again, and tendency to recommend it to others.
Measured: At the end of the 8 week invertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- One group was a control group receiving traditional treatment, and the other group was an intervention group receiving virtual reality treatment. A total of two groups.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Ece Bedir Ayar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Ece Bedir Ayar, Hasan Kalyoncu University
- Investigators
- KEZBAN YİĞİTER, PROFESSOR, Principal investigator, HASAN KALYONCU UNIVERCITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693413
- Sponsor's protocol ID
- HasanKU-FTR-01
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thijs L, Voets E, Denissen S, Mehrholz J, Elsner B, Lemmens R, Verheyden GS. Trunk training following stroke. Cochrane Database Syst Rev. 2023 Mar 2;3(3):CD013712. doi: 10.1002/14651858.CD013712.pub2.
PubMed 36864008Deathe AB, Miller WC. The L test of functional mobility: measurement properties of a modified version of the timed "up & go" test designed for people with lower-limb amputations. Phys Ther. 2005 Jul;85(7):626-35.
PubMed 15982169
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Mixed Reality Application on Upper Extremity Motor Functions and Trunk Stability in Individuals With Hemiparetic Stroke
- ClinicalTrials.gov ID
- NCT07693413
- Acronym / sponsor ID
- HasanKU-FTR-01
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, virtual reality, upper extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Emine Ece Bedir AyarUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 9 Jul 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.
The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. The use of mixed reality technology in addition to traditional rehabilitation methods provides individuals with an interactive and motivating rehabilitation environment that mimics real-life activities. The study aims to increase functional independence, improve motor skills and trunk stability, enhance upper extremity functions, facilitate return to daily living activities, increase adaptation and motivation to the rehabilitation process, and provide a repeatable, safe, and patient-centered exercise environment in stroke patients. This thesis aims to contribute to both clinical physiotherapy practice and the literature by evaluating the applicability of mixed reality technology, a patient-centered and innovative rehabilitation approach, as a treatment option in neurological rehabilitation. The study's objective in improving upper extremity function is to make the individual less dependent on others while performing daily living activities, to instill a sense of self-sufficiency, and to enhance existing skills to make them more functional.
Detailed description
The aim of this study is to investigate the effectiveness of mixed reality (MR)-based rehabilitation applications in improving motor functions, trunk stability, and upper extremity performance in stroke patients. The use of mixed reality technology in addition to traditional rehabilitation methods provides individuals with an interactive and motivating rehabilitation environment that mimics real-life activities. The population and sample of the study will consist of adult individuals with upper extremity functional limitations and stroke who are receiving treatment at the Gaziantep Metropolitan Municipality Accessible Living Center. The study will be divided into two groups, a study group and a control group, using stratified randomization. The study group will undergo upper extremity exercises using the Reach VR mixed reality application, while the control group will receive a conventional treatment program. This thesis aims to contribute to both clinical physiotherapy practice and the literature by evaluating the applicability of mixed reality technology, a patient-centered and innovative rehabilitation approach, as a treatment option in neurological rehabilitation. The aim of this study, which focuses on improving upper extremity function, is to make the individual less dependent on others for daily living activities, to instill a sense of self-sufficiency, and to enhance existing skills, thereby making them more functional.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group was a control group receiving traditional treatment, and the other group was an intervention group receiving virtual reality treatment. A total of two groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Traditional therapyControl group, receiving traditional treatment |
| Intervention group | Active comparator | Other: virtual realityIntervention group, receiving virtual reality treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18-65 who have experienced a stroke.
- At least 6 months must have passed since the stroke.
- FIM independence scale score of 50 or higher.
- Fugl-Meyer Upper Extremity Assessment (FMA) score between 23-66.
- Mini Mental Test score above 24.
Key exclusion criteria (4 listed)
- Presence of current epileptic seizures.
- Upper extremity spasticity 3-4.
- Visual or hearing loss that would affect the study.
- Individuals who have experienced multiple strokes.
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 |
|---|---|---|
| Traditional therapyThe treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will receive traditional physiotherapy treatment, including upper extremity strengthening, motor skills exercises, and balance exercises. | Other | Control group |
| virtual realityThe treatment will last 8 weeks, 3 days a week, with each session lasting 30 minutes. Participants will be playing Reach VR within the Meta Quest 3 using the eye. | Other | Intervention group |
Primary outcome
Modified Box and Block Test - mBBT
Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
The individual performs this test with both their dominant and non-dominant hand. mBBT reflects a direct assessment of individuals' upper extremity functional performance based on the number of blocks transferred from one compartment to the other within 30 seconds. At the end of the time period, the number of blocks transferred to the opposite compartment is recorded.
6 secondary outcomes
L-Shape Test
Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
Action Research Arm Test -ARAT
Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
İmpairment Scale - TIS
Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
BlazePod
Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
Specific Quality of Life Scale (SS-QOL)
Time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.
Client satisfaction Questionnaire - CSQ 8
Time frame: At the end of the 8 week invertion.
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 9 Jul 2026.
- Results publication: PubMed 36864008Thijs L, Voets E, Denissen S, Mehrholz J, Elsner B, Lemmens R, Verheyden GS. Trunk training following stroke. Cochrane Database Syst Rev. 2023 Mar 2;3(3):CD013712. doi: 10.1002/14651858.CD013712.pub2.
- Results publication: PubMed 15982169Deathe AB, Miller WC. The L test of functional mobility: measurement properties of a modified version of the timed "up & go" test designed for people with lower-limb amputations. Phys Ther. 2005 Jul;85(7):626-35.
- Individual participant dataSharing planned: No
Related trials for Stroke
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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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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.
KEZBAN YİĞİTER, PROFESSOR principal investigator
HASAN KALYONCU UNIVERCITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional therapy and virtual reality in people with Stroke, run by Emine Ece Bedir Ayar 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 5 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 9 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?
Modified Box and Block Test - mBBT (time frame: Baseline (prior to the start of treatment) and immediately after completion of the 8 week invertion.). 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 NCT07693413, which also lists 2 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 9 Jul 2026.