StrokeNCT06881680
Virtual Reality's Impact on Upper Limb Function in Post-stroke Patients
A study testing virtual reality (VR) head mounted display in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Stroke rank second among the top causes of death, affecting millions of people in the worldwide. Approximately 70-80% survivors of stroke could experience various levels of upper limb motor impairments, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- virtual reality (VR) head mounted display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First episode of stroke, hemorrhagic or ischemic, confirmed by computed tomography or magnetic resonance imaging of the brain;
- Age 40-80 years, either male or female;
- 3-12 months since stroke occurrence;
- Mild-to-moderate or moderate-to-severe upper extremity impairment, with a FMA-UE score between 16 and 53;
- Basic ability to communicate and comprehend the research instructions, with a score of 21 and above on the MMSE scale;
- Agreement to participate in the study, with an informed consent form duly signed by the patient or a family member.
Who cannot join
- The presence of ferromagnetic metals implanted in the body;
- Visual or hearing deficits;
- Unstable medical conditions;
- History of receiving similar VR training in the past;
- A history of myasthenia gravis, multiple sclerosis, muscular dystrophy, or other diseases that may cause upper limb movement disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Virtual Reality Features on Upper Limb Motor Function in Post-stroke Patients
Stroke rank second among the top causes of death, affecting millions of people in the worldwide. Approximately 70-80% survivors of stroke could experience various levels of upper limb motor impairments, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and their families. As bottleneck effect in traditional rehabilitation techniques become apparent, a number of emerging technologies are being used in rehabilitation treatment in an attempt to break down this barrier.Studies have shown that virtual reality (VR) training can effectively promote the remodeling of the central nervous system and has become an important research direction for motor function rehabilitation.However, most current studies still focus on evaluating the overall intervention effect of VR, with little examination of its intrinsic properties and a lack of exploration of the sense of ownership (SOO) and agency (SOA).
Hence, this study conducted different VR interventions on stroke patients to evaluate the effects of the intrinsic properties of VR and the body illusion it produces on the rehabilitation of their upper limb motor function.
This study is a single-blind randomized controlled trial. A total of 120 participants will be enrolled and divided into a control group, an interactive VR group, and an immersive and interactive VR group. All groups will be tested on the virtual hand illusion before the intervention. The intervention will last for a fortnight, four times a week for one hour each time. Assessment will be conducted before the intervention, at the end of the intervention, and at week 6 for follow-up. The primary outcome measure is the "Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)". The secondary outcome measures are "SOO questionnaire", "proprioceptive drift scale", "action research arm test (ARAT)", "NIH stroke scale (NIHSS)", "mini mental state examination (MMSE)", "electromyography (EMG)", "electroencephalography (EEG)" and "functional Magnetic Resonance Imaging (fMRI)".
- Conditions
- Stroke
- Being tested
- virtual reality (VR) head mounted display
- Keywords
- stroke, rehabilitation, virtual reality (VR), body representation, upper limb dysfunction
- 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 (VR) head mounted displayDevice
This group of subjects received immersive and interactive VR training, which combined rich immersive VR scenes with specific interactive tasks, including two VR scenes. Task selection was based on the subjects' upper limb functional performance, and experienced therapists provided guidance and monitoring, and adjusted the tasks when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Immersive and Interactive VR group | Experimental | The design of this group combines rich immersive VR scenes and specific interactive tasks. Specifically, there were two VR scenes: (1) Natural scenery: The subjects were on a quiet forest path, surrounded by tall trees, birdsong, and the sound of gurgling water. In this scene, the program sets the virtual hand on the hemiplegic side to perform the task of grasping the sphericalfruit on the tree. Each time the fruit is grasped for 3 seconds, and then released for 3 seconds; (2) City park: The subject was located in a city park surrounded by the sounds of children playing and the background sounds of the natural environment. In this scenario, the program sets the virtual hand on the hemiplegic side to carry out the task of grasping a ping-pong ball in the park, holding it for 3 seconds at a time and then releasing it for 3 seconds. To improve the actual participation, a real object the same as the virtual object will be provided in the real world, and subjects will be instructed to use Receives: Device: virtual reality (VR) head mounted display |
| Interactive VR group | Active comparator | The VR scene in this group focuses on basic motor interaction, and the virtual background is the same as the control group. The program will set the virtual hand on the hemiplegic side to complete specific interaction tasks, such as grasping the virtual ball, holding the virtual ball for 3 seconds each time, and then releasing it for 3 seconds. At the same time, a real sphere of the same size and color as the virtual ball will be provided in the real world, and the subject will be instructed to perform the same movement simultaneously as much as possible with the real hand on the hemiplegic side. Receives: Device: virtual reality (VR) head mounted display |
| Control group | Active comparator | subjects were asked to wear an HTC Vive HMD and enter a simple virtual testing environment. The environment has no complex narrative or visual effects, nor does it emphasize specific interaction tasks. It only includes a realistic virtual hand model of the hemiplegic side and the same virtual background as the real experiment, both are presented from a first-person perspective. The program will set the virtual hand on the hemiplegic side to perform simple and repetitive grasping movements. Each fist hold lasts for 3 seconds and then releases for 3 seconds. At the same time, the subject will be instructed to perform the same movement simultaneously with the real hand on the hemiplegic side as much as possible. Receives: Device: virtual reality (VR) head mounted display |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) covers all aspects of upper limb function, such as movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand, with a total of 33 assessment items. Patients were assessed according to a specific scale with a total score of 66, with higher scores indicating better recovery of upper limb function.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Secondary outcomes (8)
Sense of ownership questionnaire
The sense of ownership (SOO) questionnair investigates a number of aspects including sense of body ownership, sense of position in the real or virtual hand, haptic experience, body similarity, and body transformation. Scores are allocated on a 7-point Likert scale, from "Strongly disagree (-3 points)" to "Strongly agree (3 points)", depending on how much the patient agrees with each statement. The mean score of all questions is calculated as the final SOO questionnaire score, and the higher the score, the stronger the SOO.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Proprioceptive drift scale
We asked patients to report where they thought their affected hand was by pointing with their other hand or describing it verbally and compared this with the position of the affected hand they initially felt to calculate the offset distance, thereby measuring the degree of proprioceptive error.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Action Research Arm Test
The Action Research Arm Test (ARAT) consists of 19 evaluated tasks bifurcated into four subscales: grasping, gripping, pinching, and gross motor skills. The total score ranges from 0 and 57, with higher scores representing better function.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
National institutes of health stroke scale
The scale covers the level of consciousness, extraocular movements, visual fields, facial muscle function, limb strength, sensory function, coordination (ataxia), speech (aphasia), language (dysarthria), and lateralized inattention (neglect). The scoring spectrum extends from 0 to 42 points, with the higher the score, the more severe neurologic damage.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Mini-mental state examination
The Mini-Mental State Examination scale(MMSE) is mainly used to quickly assess cognitive areas such as memory, orientation, attention, calculation, language ability, and visual-spatial ability. The scale contains 30 questions with a total score range of 0-30 points. The higher the total score, the better the cognitive function. The normal threshold is divided according to the educational level (for example, those with junior high school education or above need to score ≥24 points).
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Surface electromyography
Electrodes were placed on the key muscle groups of the hemiplegic upper limb according to the Surface EMG for the Non-Invasive Assessment of Muscles guidelines. In addition to the biceps and triceps brachii muscles of the upper arm, eight electrodes were placed evenly at the maximal circumference of the forearm cross-section, in which the electrodes were distributed on the centerlines of the anterior, ulnar, posterior, and radial sides of the forearm. Before placing the electrodes, the skin surface was cleaned with alcohol and the sampling rate was set to 1000 Hz. subjects were asked to perform 11 simple normative upper limb functional tasks, which were designed by Li et al. based on the FMA-UE scale . The sEMG signals were recorded during the performance of the tasks, which were repeated three times with at least 30 seconds of rest between each trial.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Electroencephalography
The subjects were seated comfortably and asked to close their eyes, wake up, relax, and be quiet for 5 minutes. The recording electrodes were placed on the scalp according to the international 10/20 system, with the Cz electrode of the head as the reference. The impedance of each channel was ensured to be below 5k Ω and the sampling frequency was 1k Hz. EEG will be used to assess changes in brain activity by analyzing the power distribution across different frequency bands (delta, theta, alpha, beta), event-related potentials (ERPs) in response to motor tasks or stimuli, and the coherence between brain regions to evaluate motor network synchronization.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
functional Magnetic Resonance Imaging
The subjects were asked to remain still and provided with earplugs to alleviate discomfort from scanning noise. Functional images were acquired using an echo-planar imaging (EPI_BOLD) sequence with scanning parameters as follows: repetition time = 3000 ms, echo time = 30 ms, flip angle = 90 degrees, field of view = 220 × 220 mm, matrix size = 64 × 64, layer thickness = 3 mm layer position = 43, and a total of 240 time points being captured over a scanning period of 12 minutes.
Measured: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study startMar 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881680
- Sponsor's protocol ID
- KYLL-202411-013
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
PubMed 29156493Ventura S, Tessari A, Castaldini S, Magni E, Turolla A, Banos R, Lullini G. Effectiveness of a Virtual Reality rehabilitation in stroke patients with sensory-motor and proprioception upper limb deficit: A study protocol. PLoS One. 2024 Aug 12;19(8):e0307408. doi: 10.1371/journal.pone.0307408. eCollection 2024.
PubMed 39133660Tambone R, Giachero A, Calati M, Molo MT, Burin D, Pyasik M, Cabria F, Pia L. Using Body Ownership to Modulate the Motor System in Stroke Patients. Psychol Sci. 2021 May;32(5):655-667. doi: 10.1177/0956797620975774. Epub 2021 Apr 7.
PubMed 33826456Bargeri S, Scalea S, Agosta F, Banfi G, Corbetta D, Filippi M, Sarasso E, Turolla A, Castellini G, Gianola S. Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews. EClinicalMedicine. 2023 Sep 14;64:102220. doi: 10.1016/j.eclinm.2023.102220. eCollection 2023 Oct.
PubMed 37745019Goizueta S, Navarro MD, Calvo G, Campos G, Colomer C, Noe E, Llorens R. Touchscreen-based assessment of upper limb kinematics after stroke: Reliability, validity and sensitivity to motor impairment. J Neuroeng Rehabil. 2025 Feb 11;22(1):27. doi: 10.1186/s12984-025-01563-6.
PubMed 39934877
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Features on Upper Limb Motor Function in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT06881680
- Acronym / sponsor ID
- KYLL-202411-013
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, virtual reality (VR), body representation, upper limb dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 18 Mar 2025 (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.
Stroke rank second among the top causes of death, affecting millions of people in the worldwide. Approximately 70-80% survivors of stroke could experience various levels of upper limb motor impairments, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and their families. As bottleneck effect in traditional rehabilitation techniques become apparent, a number of emerging technologies are being used in rehabilitation treatment in an attempt to break down this barrier.Studies have shown that virtual reality (VR) training can effectively promote the remodeling of the central nervous system and has become an important research direction for motor function rehabilitation.However, most current studies still focus on evaluating the overall intervention effect of VR, with little examination of its intrinsic properties and a lack of exploration of the sense of ownership (SOO) and agency (SOA).
Hence, this study conducted different VR interventions on stroke patients to evaluate the effects of the intrinsic properties of VR and the body illusion it produces on the rehabilitation of their upper limb motor function.
This study is a single-blind randomized controlled trial. A total of 120 participants will be enrolled and divided into a control group, an interactive VR group, and an immersive and interactive VR group. All groups will be tested on the virtual hand illusion before the intervention. The intervention will last for a fortnight, four times a week for one hour each time. Assessment will be conducted before the intervention, at the end of the intervention, and at week 6 for follow-up. The primary outcome measure is the "Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)". The secondary outcome measures are "SOO questionnaire", "proprioceptive drift scale", "action research arm test (ARAT)", "NIH stroke scale (NIHSS)", "mini mental state examination (MMSE)", "electromyography (EMG)", "electroencephalography (EEG)" and "functional Magnetic Resonance Imaging (fMRI)".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immersive and Interactive VR group | Experimental | Device: virtual reality (VR) head mounted displayThe design of this group combines rich immersive VR scenes and specific interactive tasks. Specifically, there were two VR scenes: (1) Natural scenery: The subjects were on a quiet forest path, surrounded by tall trees, birdsong, and the sound of gurgling water. In this scene, the program sets the virtual hand on the hemiplegic side to perform the task of grasping the sphericalfruit on the tree. Each time the fruit is grasped for 3 seconds, and then released for 3 seconds; (2) City park: The subject was located in a city park surrounded by the sounds of children playing and the background sounds of the natural environment. In this scenario, the program sets the virtual hand on the hemiplegic side to carry out the task of grasping a ping-pong ball in the park, holding it for 3 seconds at a time and then releasing it for 3 seconds. To improve the actual participation, a real object the same as the virtual object will be provided in the real world, and subjects will be instructed to use |
| Interactive VR group | Active comparator | Device: virtual reality (VR) head mounted displayThe VR scene in this group focuses on basic motor interaction, and the virtual background is the same as the control group. The program will set the virtual hand on the hemiplegic side to complete specific interaction tasks, such as grasping the virtual ball, holding the virtual ball for 3 seconds each time, and then releasing it for 3 seconds. At the same time, a real sphere of the same size and color as the virtual ball will be provided in the real world, and the subject will be instructed to perform the same movement simultaneously as much as possible with the real hand on the hemiplegic side. |
| Control group | Active comparator | Device: virtual reality (VR) head mounted displaysubjects were asked to wear an HTC Vive HMD and enter a simple virtual testing environment. The environment has no complex narrative or visual effects, nor does it emphasize specific interaction tasks. It only includes a realistic virtual hand model of the hemiplegic side and the same virtual background as the real experiment, both are presented from a first-person perspective. The program will set the virtual hand on the hemiplegic side to perform simple and repetitive grasping movements. Each fist hold lasts for 3 seconds and then releases for 3 seconds. At the same time, the subject will be instructed to perform the same movement simultaneously with the real hand on the hemiplegic side as much as possible. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First episode of stroke, hemorrhagic or ischemic, confirmed by computed tomography or magnetic resonance imaging of the brain;
- Age 40-80 years, either male or female;
- 3-12 months since stroke occurrence;
- Mild-to-moderate or moderate-to-severe upper extremity impairment, with a FMA-UE score between 16 and 53;
- Basic ability to communicate and comprehend the research instructions, with a score of 21 and above on the MMSE scale;
Key exclusion criteria (5 listed)
- The presence of ferromagnetic metals implanted in the body;
- Visual or hearing deficits;
- Unstable medical conditions;
- History of receiving similar VR training in the past;
- A history of myasthenia gravis, multiple sclerosis, muscular dystrophy, or other diseases that may cause upper limb movement disorders.
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 (VR) head mounted displayThis group of subjects received immersive and interactive VR training, which combined rich immersive VR scenes with specific interactive tasks, including two VR scenes. Task selection was based on the subjects' upper limb functional performance, and experienced therapists provided guidance and monitoring, and adjusted the tasks when necessary. | Device | Control group, Immersive and Interactive VR group, Interactive VR group |
Primary outcome
Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) covers all aspects of upper limb function, such as movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand, with a total of 33 assessment items. Patients were assessed according to a specific scale with a total score of 66, with higher scores indicating better recovery of upper limb function.
8 secondary outcomes
Sense of ownership questionnaire
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Proprioceptive drift scale
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Action Research Arm Test
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
National institutes of health stroke scale
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Mini-mental state examination
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Surface electromyography
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Electroencephalography
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
functional Magnetic Resonance Imaging
Time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 29156493Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
- Background: PubMed 39133660Ventura S, Tessari A, Castaldini S, Magni E, Turolla A, Banos R, Lullini G. Effectiveness of a Virtual Reality rehabilitation in stroke patients with sensory-motor and proprioception upper limb deficit: A study protocol. PLoS One. 2024 Aug 12;19(8):e0307408. doi: 10.1371/journal.pone.0307408. eCollection 2024.
- Background: PubMed 33826456Tambone R, Giachero A, Calati M, Molo MT, Burin D, Pyasik M, Cabria F, Pia L. Using Body Ownership to Modulate the Motor System in Stroke Patients. Psychol Sci. 2021 May;32(5):655-667. doi: 10.1177/0956797620975774. Epub 2021 Apr 7.
- Background: PubMed 37745019Bargeri S, Scalea S, Agosta F, Banfi G, Corbetta D, Filippi M, Sarasso E, Turolla A, Castellini G, Gianola S. Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews. EClinicalMedicine. 2023 Sep 14;64:102220. doi: 10.1016/j.eclinm.2023.102220. eCollection 2023 Oct.
- Background: PubMed 39934877Goizueta S, Navarro MD, Calvo G, Campos G, Colomer C, Noe E, Llorens R. Touchscreen-based assessment of upper limb kinematics after stroke: Reliability, validity and sensitivity to motor impairment. J Neuroeng Rehabil. 2025 Feb 11;22(1):27. doi: 10.1186/s12984-025-01563-6.
- Effectiveness of Immersive Virtual Reality-Based Hand Rehabilitation Games for Improving Hand Motor Functions in Subacute Stroke PatientsLink provided by the sponsor.
- 360° immersive virtual reality-based mirror therapy for upper extremity function and satisfaction among stroke patients: a randomized controlled trialLink provided by the sponsor.
- Effects of virtual reality-based motor control training on inflammation, oxidative stress, neuroplasticity and upper limb motor function in patients with chronic stroke: a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 (VR) head mounted display in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
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 6 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: opening soon, as of the sponsor's last update on 18 Mar 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianxi Xu (86-18563719027, xqianxi0101@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE) (time frame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end). 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 NCT06881680, which also lists 5 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 18 Mar 2025.