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

Last updated: March 11, 2025
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Treatment

virtual reality (VR) head mounted display

Clinical Study ID

NCT06881680
KYLL-202411-013
  • Ages 40-80
  • All Genders

Study 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 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)".

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • First episode of stroke, hemorrhagic or ischemic, confirmed by computed tomographyor 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-UEscore between 16 and 53;

  • Basic ability to communicate and comprehend the research instructions, with a scoreof 21 and above on the MMSE scale;

  • Agreement to participate in the study, with an informed consent form duly signed bythe patient or a family member.

Exclusion

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 otherdiseases that may cause upper limb movement disorders.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: virtual reality (VR) head mounted display
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Qilu hospital

    Jinan, Shangdong
    China

    Site Not Available

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