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StrokeNCT06704074

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

A study testing virtual reality (VR) head mounted display in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
virtual reality (VR) head mounted display
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteChina
Study dates
9 May 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • a Head-mounted-display VR device

    Jinan, Shangdong

    jie Wang, 86-18560082446, 15854229976@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Stroke
Being tested
virtual reality (VR) head mounted display
Keywords
stroke, rehabilitation, Task-oriented training (TOT), virtual reality (VR), upper limb dysfunction
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual reality (VR) head mounted displayDevice

    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.

Study groups in NCT06704074
Study groupRoleWhat they receive
VR+TOT (task oriented training combined with occupational training)ExperimentalThe 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.
Receives: Device: virtual reality (VR) head mounted display
Traditional OTNo interventionTraditional 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)

    Measured: 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 outcomes (13)
  1. The grip strength of the hand

    Measured: 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

  2. the Modified Ashworth scale

    Measured: 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

  3. Montreal Cognitive Assessment(MoCA)

    Measured: 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

  4. Box and Block Test(BBT)

    Measured: 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

  5. Modified Barthel Index Scale(MBI)

    Measured: 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

  6. Intrinsci Motivation Inventory (IMI)

    Measured: 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

  7. Visual Analogue Scale(VAS)

    Measured: 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

  8. the sense of ownership (SOO)

    Measured: 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

  9. the questionnaire and self-location drift

    Measured: 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

  10. fNIRS

    Measured: There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks

  11. EEG

    Measured: There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks

  12. Catherine Bergego Scale(CBS)

    Measured: 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

  13. line bisection test

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start9 May 2026
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06704074
Sponsor's protocol ID
KYLL-202408(XZ)-001-3
Status last verified
Mar 2026
First submitted
11 Nov 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Malik AN, Masood T. Task-oriented training and exer-gaming for improving mobility after stroke: A randomized trial. J Pak Med Assoc. 2021 Jan;71(1(B)):186-190. doi: 10.47391/JPMA.560.

    PubMed 35157646
  • Jeong S, Chung Y. Task-Oriented Training with Abdominal Drawing-in Maneuver in Sitting Position for Trunk Control, Balance, and Activities of Daily Living in Patients with Stroke: A Pilot Randomized Controlled Trial. Healthcare (Basel). 2023 Dec 4;11(23):3092. doi: 10.3390/healthcare11233092.

    PubMed 38063660
  • Cano-de-la-Cuerda R. Influential Women in the Field of Neurological Rehabilitation: A Literature Review. Int J Environ Res Public Health. 2022 Jan 20;19(3):1112. doi: 10.3390/ijerph19031112.

    PubMed 35162136
  • Huang J, Ji JR, Liang C, Zhang YZ, Sun HC, Yan YH, Xing XB. Effects of physical therapy-based rehabilitation on recovery of upper limb motor function after stroke in adults: a systematic review and meta-analysis of randomized controlled trials. Ann Palliat Med. 2022 Feb;11(2):521-531. doi: 10.21037/apm-21-3710.

    PubMed 35249330

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality (VR) head mounted display in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jing Jing (86-18560083588, 517334583@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06704074, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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Clinical Trial NCT06704074 | AzTrials