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

NCT06704074 | Recruiting DMC

• 1 other identifier: KYLL-202408（XZ）-001-3
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

stroke; rehabilitation; Task-oriented training (TOT); virtual reality (VR); upper limb dysfunction

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)

  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)

• The grip strength of the hand

  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

  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)

  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）

  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)

  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

Other Outcomes (2)

• National Institute of Health Stroke Scale(NIHSS)

  after screening for enrollment but before study initiation

• the Virtual Reality Symptom Questionnaire(VRSQ)

  There were 2 time points for evaluation: the intervention of 2 weeks, the intervention of 4 weeks

Study Arms (2)

VR+TOT (task oriented training combined with occupational training)

EXPERIMENTAL

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

Traditional OT

NO INTERVENTION

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.).

Interventions

virtual reality (VR) head mounted display DEVICE

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.

VR+TOT (task oriented training combined with occupational training)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Jinan Hospital: collaborator
• Jinan Seventh People's Hospital: collaborator
• Qilu Hospital of Shandong University: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Shanghai Yangzhi Rehabilitation Hospital: collaborator
• Beihang University: collaborator
• Huashan Hospital: collaborator

Study Sites (1)

a Head-mounted-display VR device

Jinan, Shangdong, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 35157646 BACKGROUND

• 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.

  PMID: 38063660 BACKGROUND

• 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.

  PMID: 35162136 BACKGROUND

• 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.

  PMID: 35249330 BACKGROUND

Related Links

• The Effect of Task-Oriented Activities Training on Upper-Limb Function, Daily Activities, and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial
• Effects of task-oriented training on upper extremity function and performance of daily activities by chronic stroke patients
• task-oriented training in the treatment of developmental coordination disorder
• observe the effect of a family-centered task-oriented training (TOT) program on the functional independence and life quality of children with spastic cerebral palsy
• observe any effect of task-oriented training in the activities of daily living (ADL) for stroke patients.

MeSH Terms

Conditions

Stroke

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

jing Jing

CONTACT

86-18560083588; 517334583@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 25, 2024
• Study Start: April 5, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-07

Locations

CN (1)