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| Name | Class |
|---|---|
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Shanghai Sunshine Rehabilitation Center | OTHER |
| Beihang University | OTHER |
| Huashan Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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.). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jing Jing | Contact | 86-18560083588 | 517334583@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| a Head-mounted-display VR device | Recruiting | Jinan | Shangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35157646 | Background | 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. | |
| 38063660 | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000080310 | Smart Glasses |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| OTHER |
| Jinan Hospital | UNKNOWN |
| Jinan Seventh People's Hospital | UNKNOWN |
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|
| 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 |
| Intrinsci Motivation Inventory (IMI) | 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 |
| Visual Analogue Scale(VAS) | 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 |
| the sense of ownership (SOO) | 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 | 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 |
| fNIRS | There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks |
| EEG | There were 2 time points for evaluation: after screening for enrollment but before study initiation, the intervention of 4 weeks |
| Catherine Bergego Scale(CBS) | 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 | 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 |
| 35162136 | 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. |
| 35249330 | 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. |
| Effects of task-oriented training on upper extremity function and performance of daily activities by chronic stroke patients | View source |
| task-oriented training in the treatment of developmental coordination disorder | View source |
| 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 | View source |
| observe any effect of task-oriented training in the activities of daily living (ADL) for stroke patients. | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |