Not yet taking people in ChinaNo phase

Virtual reality training for arm movement after stroke

Tests virtual reality headsets for arm recovery in people after a stroke.

Key facts

Who runs it: Qilu Hospital of Shandong University
Where: Jinan, ChinaSee the site
Trial code: NCT06881680
Registry title: Virtual Reality's Impact on Upper Limb Function in Post-stroke Patients
Status: Not yet recruiting
People taking part: 120 people, planned
Started: Mar 2025
Expected to end: 30 Nov 2027
Type of study: Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested: virtual reality (VR) head mounted display
Record updated: 18 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 80 who had a first stroke 3 to 12 months ago and have weak movement in one arm. It tests virtual reality training for the arm.

Age: 40 to 80 years
Sex: Men and women
Disease stage: First stroke (bleeding or clot), confirmed by a brain scan, 3 to 12 months ago. Mild-to-moderate or moderate-to-severe arm impairment, with a FMA-UE score between 16 and 53.
Earlier treatment: People who have had similar VR training in the past cannot join.
Biomarker or test result: A score of 21 or more on the MMSE (a thinking and memory test).

Main reasons for not taking part

Metal that can be magnetised (ferromagnetic) implanted in the body
Vision or hearing problems
Unstable medical conditions
Earlier similar VR training
Myasthenia gravis, multiple sclerosis, muscular dystrophy or other diseases that may affect arm movement

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

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 take part

History of receiving similar VR training in the past
Unstable medical conditions
A history of myasthenia gravis, multiple sclerosis, muscular dystrophy, or other diseases that may cause upper limb movement disorders
The presence of ferromagnetic metals implanted in the body
Visual or hearing deficits

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 40 and 80 years old?

Where in China

Qilu HospitalJinan, ChinaContact: Qianxi XuNo longer taking part

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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)".

The 3 groups in the trial

Immersive and Interactive VR groupTreatment being tested
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
Treatment: virtual reality (VR) head mounted display
Interactive VR groupExisting treatment, for comparison
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.
Treatment: virtual reality (VR) head mounted display
Control groupExisting treatment, for comparison
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.
Treatment: virtual reality (VR) head mounted display