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Not yet recruiting NCT06881680

Virtual Reality's Impact on Upper Limb Function in Post-stroke Patients

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual reality (VR) head mounted display.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Virtual Reality Features on Upper Limb Motor Function in Post-stroke Patients

Overview

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)".

Interventions

  • Device virtual reality (VR) head mounted display
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Qilu hospital — Jinan

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 39934877

Identifiers

NCT: NCT06881680 · KYLL-202411-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗