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NCT06704074 | NOT YET RECRUITING | Stroke

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

Qilu Hospital of Shandong University

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.

Condition or disease

Stroke

Intervention/treatment

virtual reality (VR) head mounted display

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Effectiveness of Real Home Settings Via Virtual Reality Task Oriented Training on Upper Limb Function in Patients With Stroke
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2026-05-31
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 \> Ⅰ, modified Ashworth grade \< 4; 4. Patients can sit and stand for upper limb function assessment and rehabilitation training; 5. No severe cognitive impairment, MMSE \> 17, able to accurately understand the questionnaire questions and scoring criteria, and complete the body drift test; No history of serious mental illness; 6. No obvious abnormality in visual acuity or corrected visual acuity; There was no obvious abnormality in hearing. There was no sensory aphasia or unilateral neglect.
  • 7. 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. Skull defect or allogeneic repair; 3. combined with other neurological and mental diseases; 4. 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.
  • 5. 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. Evidence of ataxia and cerebellar or brainstem lesions according to the NIHSS; 8. Ongoing participation in other clinical investigators; 9. Unstable condition, refusal to sign the informed consent, and unwillingness to cooperate with the examination and treatment.
Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients

Location Details

NCT06704074

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Locations

Not yet recruiting

China, Shangdong

a Head-mounted-display VR device

Women, Shangdong, China,