Clinical trial NCT06704074: Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients
Official title: Effectiveness of Real Home Settings Via Virtual Reality Task Oriented Training on Upper Limb Function in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
Task-oriented training (TOT)
virtual reality (VR)
upper limb dysfunction
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Chongqing Medical University
name: Shanghai Yangzhi Rehabilitation Hospital
name: Beihang University
name: Huashan Hospital
First posted: 2024-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)
timeFrame: 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
Secondary outcomes:
measure: Wolf motor function test（WMFT）
timeFrame: 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
measure: The grip strength of the hand
timeFrame: 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
measure: the Modified Ashworth scale
timeFrame: 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
measure: Box and Block Test（BBT）
timeFrame: 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
measure: Modified Barthel Index Scale(MBI)
timeFrame: 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
measure: Intrinsci Motivation Inventory (IMI)
timeFrame: the intervention of 2 weeks, the intervention of 4 weeks
measure: Visual Analogue Scale（VAS）
timeFrame: the intervention of 2 weeks, the intervention of 4 weeks
measure: the sense of ownership (SOO)
timeFrame: 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
measure: the questionnaire and self-location drift
timeFrame: 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
measure: fNIRS
timeFrame: 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
measure: EEG
timeFrame: 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
Other outcomes:
measure: Mini Mental State Examination(MMSE)
timeFrame: screening for enrollment
measure: National Institute of Health Stroke Scale(NIHSS)
timeFrame: after screening for enrollment but before study initiation
measure: the Virtual Reality Symptom Questionnaire(VRSQ)
timeFrame: the intervention of 2 weeks, the intervention of 4 weeks
Locations:
city: Jinan
country: China
facility: a Head-mounted-display VR device
state: Shangdong
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.