Upper Extremity HemiplegiaNCT07378085
Virtual Reality-Based Upper Limb Rehabilitation in Hemiplegia
A study testing conventional rehabilitation and leap motion based virtual reality rehabilitation in people with Upper Extremity Hemiplegia and Stroke, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of Leap Motion-supported virtual reality therapy, applied in addition to traditional rehabilitation programs, in individuals who develop hemiplegia after a cerebrovascular accident. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Hemiplegia, Stroke, Virtual Reality Based Therapy
- What is being tested?
- conventional rehabilitation and leap motion based virtual reality rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2023to 1 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be above eighteen years of age
- Have had a first-time stroke
- Be within twelve months of stroke
- Have a Brunnstrom score of four or more for the upper extremity
- Be cognitively adequate (scoring ≥23 on the mini-mental test scale)
Who cannot join
- Being in the unstable phase of the disease
- Visual and/or auditory impairments
- Unilateral spatial neglect (hemineglect)
- Modified Ashworth Scale score of ≥3 in the affected upper limb
- Had a history of botulinum toxin A (Botox) injection in the affected upper limb within the previous six months
- Other systemic neuromuscular disorders (exc; Alzheimer Disease, Parkinson Disease, Multipl Sclerosis...)
Show all 9Show fewer
- Have cerebellar involvement characterised by dysmetria, dysdiadochokinesia or ataxia
- Have a prior orthopaedic or neuromuscular injuries affecting both upper limbs
- Have impaired static sitting balance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital
Istanbul, 34255
About this study
Official title: The Impact of Virtual Reality Games on Upper Extremity Function, Activity, and Participation in Hemiplegic Patients: A Randomized Controlled Trial
This study aims to evaluate the effectiveness of Leap Motion-supported virtual reality therapy, applied in addition to traditional rehabilitation programs, in individuals who develop hemiplegia after a cerebrovascular accident. The study will examine the effects of this additional therapy on upper extremity functions, activities of daily living, and participation levels.
Read the detailed description
Hemiplegic patients experience significant limitations in their activities of daily living (ADL) and participation levels due to marked losses in upper extremity function following stroke. Approximately 80% of individuals who have had a stroke experience impairment in upper extremity function, and because the upper extremity plays a critical role in many motor functions, these impairments significantly affect independence. Therefore, initiating upper extremity rehabilitation early and tailoring it to the individual's needs is of great importance for functional improvement. Various treatment methods are used in stroke rehabilitation to support physical, functional, and psychological recovery.
In recent years, virtual reality-based technologies have been increasingly used in rehabilitation processes due to their ability to increase motivation, enable intensive and repetitive motor training, and provide environmental feedback. Leap Motion-based virtual reality applications enable patients to participate in therapy through safe, interactive, and task-oriented activities by allowing three-dimensional perception of upper extremity movements.
The aim of this study is to compare the effects of Leap Motion-based virtual reality rehabilitation, applied in addition to conventional treatment, on the functional development of the plegic upper extremity, activities of daily living, and participation levels compared to the group receiving conventional treatment alone.
- Being tested
- conventional rehabilitation, leap motion based virtual reality rehabilitation
- Keywords
- stroke rehabilitation, virtual reality, upper extremity, motor skills, leap motion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional rehabilitationOther
Conventional rehabilitation consisted of joint range of motion exercises, stretching, strengthening, balance and postural control training, transfer training, gait training, stair climbing exercises, and neurophysiological exercise techniques, all performed under the supervision of a physiotherapist.
leap motion based virtual reality rehabilitationDevice
The VR system was implemented using the Leap Motion device, which incorporates an infrared depth sensor capable of detecting limb movements in three-dimensional space. This technology enables users to interact with the virtual environment without the need for a handheld controller; instead, the user's upper extremities function directly as the interface. During the intervention, patients participated in computer-based rehabilitation while seated, with the motion sensor positioned to accurately capture hand and wrist movements.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The control group received conventional rehabilitation for 1 hour every day, 5 days a week for 4 weeks. Receives: Other: conventional rehabilitation |
| experimental group | Active comparator | In addition to conventional rehabilitation, participants in the experimental group received Leap Motion-based virtual reality therapy 5 days per week for 4 weeks. For this purpose, the Leap Motion device, leased from Becure GmbH (GOSB Teknopark Hightech Building, Gebze, Kocaeli, Turkey), was used to deliver a computer-based HandROM program designed to improve upper extremity functions. Each session consisted of 4 games, played for 10 minutes each, resulting in a total of 40 minutes of additional upper extremity exercise per day. Four therapeutic games used in intervention are as follows: Leap Maze, Leap Ball , Pong and CatchAPet. During the games, patients performed forearm pronation-supination, wrist flexion-extension, and finger flexion-extension movements. Receives: Other: conventional rehabilitation; Device: leap motion based virtual reality rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment for upper extremity
In our study, we used the upper extremity motor evaluation part of the Fugl-Meyer scale. This scale is valid and reliable in evaluating motor recovery after stroke. This scale has 4 subheadings: arm evaluation (maximum 36 points), wrist evaluation (10 points), hand evaluation (maximum 14 points), coordination and speed (maximum 6 points). It consists of 33 items scored from 0 to 2. '0: Cannot realize, 1: Partially realizes, 2: Completely realizes'. A maximum of 66 points can be obtained in the upper extremity scoring. Higher scores indicate better motor recovery.
Measured: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Secondary outcomes (4)
Selective Control of the Upper Extremity Scale
It evaluates selective movements in the shoulder, elbow, forearm, wrist and fingers. The person to be evaluated is seated at a table wearing appropriate clothing so that his or her extremities can be clearly seen. The assessor himself shows how to perform the movements. Then the participant actively performs the movement. While the participant is performing the movements, the movements of the head, trunk and both extremities are recorded on a video camera so that they are fully visible. Scoring for each joint is "Normal Selective Motor Control" (3 points), "Mildly Decreased Selective Motor Control" (2 points), "Moderately Decreased Selective Motor Control" (1 point), and "No Selective Motor Control" (0 points). score). A maximum of 15 points can be obtained for the extremity evaluated. A higher score indicates better selective motor control in that limb.
Measured: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Stroke Specific Quality of Life Scale
It is used to evaluate quality of life after stroke. SS-QOL consists of 12 subsections (mobility (6 items), energy (3 items), upper extremity function (5 items), work/production (3 items), temperament (5 items), self-care (5 items), social role (5 items). item), family role (3 items), vision (3 items), language (5 items), thinking (3 items) and personality traits (3 items) and a total of 49 questions. Each question was rated with a Likert-type score ranging from 1 to 5. Rating "1. "I couldn't do it at all, 2. I found it very difficult, 3. I found it a little difficult, 4. I found it very little difficult, 5. I did not find it difficult at all." A maximum of 245 points can be obtained. A high scale score indicates a high quality of life, and a low scale score indicates a low quality of life.
Measured: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Turkish Version of Disabilities of The Arm, Shoulder and Hand
This questionnaire was developed to evaluate the functional status and ability to perform activities of daily living in patients with upper extremity injuries. In our study, the first part of the DASH-T survey, consisting of 30 questions, was applied. Of these 30 questions, 21 evaluate the person's difficulties during daily living activities, 5 evaluate the symptoms (pain, stiffness, tingling, weakness), and 4 evaluate work, sleep, social function and self-confidence. The person answers all questions according to a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do it at all). When calculating the total score, the total score of the marked items is divided by the number of marked items and subtracted by 1. The result is then multiplied by 25. A score between 0-100 is obtained. As the score increases, the disability also increases.
Measured: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
nine hole peg test
The Nine-Hole Peg Test (NHPT) is a simple test of manual dexterity. It assesses fine motor coordination and finger-hand speed. Participants pick up nine pegs from a container, one by one, and insert them into the holes on a pegboard as quickly as possible. Participants must remove pegs one by one and return them to the container after inserting them. The stopwatch records the time taken. Longer times indicate poorer manual dexterity
Measured: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start23 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
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 Upper Extremity 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a single-blind, prospective, randomized controlled, single-center study. Patients were randomly assigned to the experimental group (EG) or the control group (CG). A box containing 40 opaque, sealed envelopes was prepared: 20 labeled "CG" and 20 "EG". Occupational therapists asked participants to draw one envelope. If they withdrew from the study, the envelope corresponding to their group was returned. The study continued until all 40 envelopes had been drawn and complete data were collected.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pinar Dogan, Gaziosmanpasa Research and Education Hospital
- Investigators
- Pinar Dogan, MD, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378085
- Sponsor's protocol ID
- 07
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data obtained from patients participating in the statistical analysis will be shared without disclosing patient identities.
Publications
Ogun MN, Kurul R, Yasar MF, Turkoglu SA, Avci S, Yildiz N. Effect of Leap Motion-based 3D Immersive Virtual Reality Usage on Upper Extremity Function in Ischemic Stroke Patients. Arq Neuropsiquiatr. 2019 Oct 24;77(10):681-688. doi: 10.1590/0004-282X20190129. eCollection 2019.
PubMed 31664343Wang ZR, Wang P, Xing L, Mei LP, Zhao J, Zhang T. Leap Motion-based virtual reality training for improving motor functional recovery of upper limbs and neural reorganization in subacute stroke patients. Neural Regen Res. 2017 Nov;12(11):1823-1831. doi: 10.4103/1673-5374.219043.
PubMed 29239328Shin JH, Kim MY, Lee JY, Jeon YJ, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016 Feb 24;13:17. doi: 10.1186/s12984-016-0125-x.
PubMed 26911438
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality Games on Upper Extremity Function, Activity, and Participation in Hemiplegic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07378085
- Acronym / sponsor ID
- 07
- Keywords
- stroke rehabilitation, virtual reality, upper extremity, motor skills, leap motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 30 Jan 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 study aims to evaluate the effectiveness of Leap Motion-supported virtual reality therapy, applied in addition to traditional rehabilitation programs, in individuals who develop hemiplegia after a cerebrovascular accident. The study will examine the effects of this additional therapy on upper extremity functions, activities of daily living, and participation levels.
Detailed description
Hemiplegic patients experience significant limitations in their activities of daily living (ADL) and participation levels due to marked losses in upper extremity function following stroke. Approximately 80% of individuals who have had a stroke experience impairment in upper extremity function, and because the upper extremity plays a critical role in many motor functions, these impairments significantly affect independence. Therefore, initiating upper extremity rehabilitation early and tailoring it to the individual's needs is of great importance for functional improvement. Various treatment methods are used in stroke rehabilitation to support physical, functional, and psychological recovery.
In recent years, virtual reality-based technologies have been increasingly used in rehabilitation processes due to their ability to increase motivation, enable intensive and repetitive motor training, and provide environmental feedback. Leap Motion-based virtual reality applications enable patients to participate in therapy through safe, interactive, and task-oriented activities by allowing three-dimensional perception of upper extremity movements.
The aim of this study is to compare the effects of Leap Motion-based virtual reality rehabilitation, applied in addition to conventional treatment, on the functional development of the plegic upper extremity, activities of daily living, and participation levels compared to the group receiving conventional treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a single-blind, prospective, randomized controlled, single-center study. Patients were randomly assigned to the experimental group (EG) or the control group (CG). A box containing 40 opaque, sealed envelopes was prepared: 20 labeled "CG" and 20 "EG". Occupational therapists asked participants to draw one envelope. If they withdrew from the study, the envelope corresponding to their group was returned. The study continued until all 40 envelopes had been drawn and complete data were collected.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: conventional rehabilitationThe control group received conventional rehabilitation for 1 hour every day, 5 days a week for 4 weeks. |
| experimental group | Active comparator | Other: conventional rehabilitation, Device: leap motion based virtual reality rehabilitationIn addition to conventional rehabilitation, participants in the experimental group received Leap Motion-based virtual reality therapy 5 days per week for 4 weeks. For this purpose, the Leap Motion device, leased from Becure GmbH (GOSB Teknopark Hightech Building, Gebze, Kocaeli, Turkey), was used to deliver a computer-based HandROM program designed to improve upper extremity functions. Each session consisted of 4 games, played for 10 minutes each, resulting in a total of 40 minutes of additional upper extremity exercise per day. Four therapeutic games used in intervention are as follows: Leap Maze, Leap Ball , Pong and CatchAPet. During the games, patients performed forearm pronation-supination, wrist flexion-extension, and finger flexion-extension movements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be above eighteen years of age
- Have had a first-time stroke
- Be within twelve months of stroke
- Have a Brunnstrom score of four or more for the upper extremity
- Be cognitively adequate (scoring ≥23 on the mini-mental test scale)
Key exclusion criteria (9 listed)
- Being in the unstable phase of the disease
- Visual and/or auditory impairments
- Unilateral spatial neglect (hemineglect)
- Modified Ashworth Scale score of ≥3 in the affected upper limb
- Had a history of botulinum toxin A (Botox) injection in the affected upper limb within the previous six months
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 |
|---|---|---|
| conventional rehabilitationConventional rehabilitation consisted of joint range of motion exercises, stretching, strengthening, balance and postural control training, transfer training, gait training, stair climbing exercises, and neurophysiological exercise techniques, all performed under the supervision of a physiotherapist. | Other | control group, experimental group |
| leap motion based virtual reality rehabilitationThe VR system was implemented using the Leap Motion device, which incorporates an infrared depth sensor capable of detecting limb movements in three-dimensional space. This technology enables users to interact with the virtual environment without the need for a handheld controller; instead, the user's upper extremities function directly as the interface. During the intervention, patients participated in computer-based rehabilitation while seated, with the motion sensor positioned to accurately capture hand and wrist movements. | Device | experimental group |
Primary outcome
Fugl-Meyer assessment for upper extremity
Time frame: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
In our study, we used the upper extremity motor evaluation part of the Fugl-Meyer scale. This scale is valid and reliable in evaluating motor recovery after stroke. This scale has 4 subheadings: arm evaluation (maximum 36 points), wrist evaluation (10 points), hand evaluation (maximum 14 points), coordination and speed (maximum 6 points). It consists of 33 items scored from 0 to 2. '0: Cannot realize, 1: Partially realizes, 2: Completely realizes'. A maximum of 66 points can be obtained in the upper extremity scoring. Higher scores indicate better motor recovery.
4 secondary outcomes
Selective Control of the Upper Extremity Scale
Time frame: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Stroke Specific Quality of Life Scale
Time frame: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
Turkish Version of Disabilities of The Arm, Shoulder and Hand
Time frame: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
nine hole peg test
Time frame: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
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 30 Jan 2026.
- Background: PubMed 31664343Ogun MN, Kurul R, Yasar MF, Turkoglu SA, Avci S, Yildiz N. Effect of Leap Motion-based 3D Immersive Virtual Reality Usage on Upper Extremity Function in Ischemic Stroke Patients. Arq Neuropsiquiatr. 2019 Oct 24;77(10):681-688. doi: 10.1590/0004-282X20190129. eCollection 2019.
- Background: PubMed 29239328Wang ZR, Wang P, Xing L, Mei LP, Zhao J, Zhang T. Leap Motion-based virtual reality training for improving motor functional recovery of upper limbs and neural reorganization in subacute stroke patients. Neural Regen Res. 2017 Nov;12(11):1823-1831. doi: 10.4103/1673-5374.219043.
- Background: PubMed 26911438Shin JH, Kim MY, Lee JY, Jeon YJ, Kim S, Lee S, Seo B, Choi Y. Effects of virtual reality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial. J Neuroeng Rehabil. 2016 Feb 24;13:17. doi: 10.1186/s12984-016-0125-x.
- Individual participant dataSharing planned: Yes. The data obtained from patients participating in the statistical analysis will be shared without disclosing patient identities.
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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.
Pinar Dogan, MD principal investigator
Gaziosmanpasa Research and Education 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 conventional rehabilitation and leap motion based virtual reality rehabilitation in people with Upper Extremity Hemiplegia and Stroke, run by Gaziosmanpasa Research and Education 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 5 inclusion and 9 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 30 Jan 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?
Fugl-Meyer assessment for upper extremity (time frame: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)). 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 NCT07378085, 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 30 Jan 2026.