Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06704074

Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients

Led by Qilu Hospital of Shandong University · Updated on 2026-04-02

86

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

Q

Qilu Hospital of Shandong University

Lead Sponsor

F

First Affiliated Hospital of Chongqing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Stroke rank second among the top causes of death, affecting millions of people in the worldwide. It has been reported that hemiplegia is the most common sequelae after stroke, accounting for about 50%-70% of all sequelae of the disease. About 75% of stroke patients are accompanied by different degrees of upper limb dysfunction, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and their families. Early recovery of upper limb motor function is a great significance for the overall recovery of stroke patients. Task-oriented training (TOT) is reported to improve the motor coordination and ADL. However, lack varies of tasks limited the treatment ability for patients with stroke hemiplegia during hospital admission. Virtual reality (VR) offers advantages of providing virtual scenes that is difficult in the real world, such as the scene of garden, camara, and plaza etc. And the familiar circumstances for patients may have the potential to increase the motivation of rehabilitation training, and improve the efficacy of occupational therapy (OT). The goal of this study is to observe the effectiveness of real home settings via virtual reality assisted TOT on upper limb function in patients with stroke. Functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG) were used to observe the changes in brain function under VR-TOT training. We intended to recruit 120 participants, and allocate to three groups: VR-TOT, TOT, and traditional OT. Each of them completed the Fugl-Meyer-UE, Wolf motor function test (WMFT), hand gripping power, modified Ashworth、Purdue Pegboard test (PPT)、modified Barthel index (MBI)、mini mental state examination (MMSE)、NIH stroke scale (NIHSS)、Virtual reality sickness questionnaire (VRSQ), Intrinsic Motivation Inventory Inventory (IMI), satisfaction VAS, body representation, sense of ownership, Proprioceptive Drift scale before and after the treatment. Additionally, we conducted fNIRS and EEG at baseline and during the follow up to understand the changes in brain function.

CONDITIONS

Official Title

Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed ischemic or hemorrhagic stroke confirmed by history and CT or MRI imaging
  • First stroke occurring 1 to 6 months before enrollment
  • Age between 18 and 80 years
  • Hemiplegia with Brunnstrom stage II to IV and modified Ashworth grade less than 4
  • Able to maintain sitting balance with no or minimal assistance for at least 30 minutes
  • No significant unilateral neglect as confirmed by tests such as the Schenkenberg Line Bisection Test
  • Sufficient vision and hearing to participate in virtual reality training and follow instructions
  • Signed informed consent by the patient or family member
Not Eligible

You will not qualify if you...

  • History of previous stroke, traumatic or non-vascular brain injury
  • MOCA score less than or equal to 17 without sensory aphasia
  • Skull defect or allogeneic repair
  • Other neurological or mental diseases
  • Medical conditions causing upper limb motor or sensory dysfunction, including neck tumor, radiotherapy or chemotherapy history, cervical spondylosis, cervical spine or upper limb fractures, brachial plexus injury, arthritis, diabetes, myasthenia gravis, multiple sclerosis
  • Symptoms of vertigo, dizziness, or related disorders such as motion sickness, Meniere's syndrome, or otolithiasis
  • Significant pain in affected upper limb or shoulder with VAS score 4 or higher at rest or during activity
  • Evidence of ataxia or cerebellar or brainstem lesions based on NIH stroke scale
  • Participation in other clinical trials
  • Unstable condition, refusal to consent, or unwillingness to cooperate with study procedures

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

a Head-mounted-display VR device

Jinan, Shangdong, China

Actively Recruiting

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Research Team

J

jing Jing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients | DecenTrialz