Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients

Study Overview
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Brief Summary
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Quantitative assessment method developed for brain plasticity through disability rehabilitation using a brain imaging technique. Development of brain imaging technology to improve understanding of brain plasticity during rehabilitation and to improve the efficiency of rehabilitation treatment for people with brain injury. ○ Development of the latest brain function image analysis algorithm and data processing technology Development of new technology for imaging brain plasticity in addition to existing functional imaging technology and diffuse imaging technology (Example: Myelinated brain imaging technology, susceptibility imaging (SWI) technology) Development of image reconstruction software technology using new image technology Multi-image and repeated shot data processing technology, wheat analysis technology development (Example: 3D registration technology, automated segmentation technology) Conducted clinical research on clinical quantitative evaluation of brain plasticity due to rehabilitation treatment Recruitment of a group of patients for pursuing plasticity through rehabilitation among stroke patients (estimating the number of sample patients by setting a specific patient group and analyzing statistical power) Image-based brain change analysis through patient rehabilitation and before and after imaging Comparative analysis through securing a control group and activating the control group. Derivation of clinical relevance through comparison with rehabilitation process

Official Title
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Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients: Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: upper robot Robot assisted upper arm training(RAT)
* Behavioral: Conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: less than 6 months after onset of the stroke have FMA score greater than 7 have confirmed that the integrity of the Corticospinal Tract (CST) is preserved in Diffusion Tensor Imaging (DTI) taken using over 20 years of age can understand and participated in study consented to this study in writing or verbally Exclusion Criteria: quadriplegia past history of stroke past history of Musculoskeletal disease or history of Neurological diseases have a history of injury to the upper limb and upper chest, surgery, or peripheral nerve damage have skin ulcers or skin diseases such as open wounds that have difficulty applying RAT Pregnant woman If it is judged that this clinical participation is not appropriate according to the judgment of medical doctor

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br> | Device: upper robot Robot assisted upper arm training(RAT)<br>* The training group received an additional upper robot Robot assisted upper arm training(RAT) with Armeopower® 5 times per week for 4weeks. *Robot Assisted Arm training + Conventional occupational therapy<br>|
| Other: Control group<br> | Behavioral: Conventional therapy<br>* The control group received the usual conventional therapy *Only Conventional occupational therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia | before training(0week) | 
| Fugl-Meyer Assessment (FMA) | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia | after training(4week) |