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

March 29, 2026 updated by: Qilu Hospital of Shandong University

Effectiveness of Real Home Settings Via Virtual Reality Task Oriented Training on Upper Llimb Function in Patients With Stroke: A Multicenter, Randomized Controlled Clinical Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shangdong
      • Jinan, Shangdong, China
        • Recruiting
        • a Head-mounted-display VR device
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-1. Ischemic or hemorrhagic stroke was diagnosed based on the history, symptoms, and signs combined with CT or MRI imaging; 2. First stroke, onset time from 1 to 6 months, age ≥ 18 - 80 years ; 3. Hemiplegia, Brunnstrom stage ≥ Ⅱ - Ⅴ, modified Ashworth grade < 4; 4. Able to maintain sitting balance (with no or only minimal assistance) for at least 30 minutes to facilitate assessment and training; 5. No significant unilateral neglect (confirmed by tests such as the Schenkenberg Line Bisection Test); visual or corrected vision and hearing must be sufficient to meet the requirements for VR training and to understand instructions.

6.Patients or their family members signed informed consent to participate in the experiment.

Exclusion Criteria:

  • 1. Previous history of stroke, traumatic or non-vascular encephalopathy; 2. MOCA ≤ 17, and no sensory aphasia. 3. Skull defect or allogeneic repair; 4. combined with other neurological and mental diseases; 5. Previous diseases that may cause upper limb motor/sensory dysfunction, such as neck tumor or radiotherapy and chemotherapy history, cervical spondylosis, cervical spine or upper limb fracture history, traumatic brachial plexus injury history, arthritis, diabetes mellitus, myasthenia gravis, multiple sclerosis, etc.

    6. Accompanied by obvious vertigo or dizziness symptoms or related diseases (such as motion sickness, Meniere's syndrome, otolithiasis, etc.); 6. Accompanied by obvious pain; 7. Significant pain in the affected upper limb or shoulder at rest or during activity (VAS ≥ 4 ) 8. Evidence of ataxia and cerebellar or brainstem lesions according to the NIHSS; 9. Ongoing participation in other clinical investigators; 10. Unstable condition, refusal to sign the informed consent, and unwillingness to cooperate with the examination and treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR+TOT (task oriented training combined with occupational training)
The participants in this group are given VR-TOT training, which was created a virtual scene based on the participants' home and completed a series of occupational tasks. A Head-mounted-display VR device is used in this group.
Device: virtual reality (VR) head mounted display
The participants' in this group were given VR-TOT training under real home scenes created in the platform of Unity. There were 6 VR-TOT tasks, and the task choice was according to the performance of participants' upper limb function. The experienced therapist will guide and monitor the participants and adjust the task if necessary.
No Intervention: Traditional OT
Traditional OT , including but not limited : upper limb joints (shoulder, elbow, wrist, interphalangeal), muscle sensory stimulation (such as tapping, brushing, squeezing, etc.), active and passive range of motion training of upper limb joints, upper limb muscle strength training, wrist dorsal extension, grip and other training were carried out by using a roller and wooden nail board. ADL training (dressing, grooming, washing, eating, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)
Time Frame: There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks，1 month after the intervention
There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks，1 month after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
The grip strength of the hand
Time Frame: There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
the Modified Ashworth scale
Time Frame: There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
the sense of ownership (SOO)
Time Frame: There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
the questionnaire and self-location drift
Time Frame: There were 3 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 2 weeks, the intervention of 4 weeks
Box and Block Test（BBT）
Time Frame: There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
Intrinsci Motivation Inventory (IMI)
Time Frame: There were 3 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 2 weeks, the intervention of 4 weeks
Catherine Bergego Scale（CBS）
Time Frame: There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
line bisection test
Time Frame: There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
Montreal Cognitive Assessment(MoCA)
Time Frame: There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
Modified Barthel Index Scale(MBI)
Time Frame: There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks, 1 month after the intervention
There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks, 1 month after the intervention
Visual Analogue Scale（VAS）
Time Frame: There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks，1 month after the intervention
There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks，1 month after the intervention
fNIRS
Time Frame: There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks
There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks
EEG
Time Frame: There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks
There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
National Institute of Health Stroke Scale(NIHSS)
Time Frame: after screening for enrollment but before study initiation
after screening for enrollment but before study initiation
the Virtual Reality Symptom Questionnaire(VRSQ)
Time Frame: There were 2 time points for evaluation: the intervention of 2 weeks, the intervention of 4 weeks
There were 2 time points for evaluation: the intervention of 2 weeks, the intervention of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Huashan Hospital
First Affiliated Hospital of Chongqing Medical University
Beihang University
Shanghai Yangzhi Rehabilitation Hospital
Jinan Hospital
Jinan Seventh People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 5, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202408（XZ）-001-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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