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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Qianxi Xu contact

86-18563719027

xqianxi0101@163.com

China1 site

  • Qilu hospital

    Jinan, Shangdong

Other trials in China

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 groups in NCT06881680
Study groupRoleWhat they receive
Immersive and Interactive VR groupExperimentalThe 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 groupActive comparatorThe 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 groupActive comparatorsubjects 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted18 Mar 2025
  2. Study startMar 2025 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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)
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 29156493

  • Ventura 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 39133660

  • Tambone 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 33826456

  • Bargeri 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 37745019

  • Goizueta 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

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.

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