Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
upper robot Robot assisted upper arm training(RAT)
Conventional therapy
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Yonsei Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Training group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651322
Brief Title
Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients
Official Title
Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
upper robot Robot assisted upper arm training(RAT)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional therapy
Intervention Description
The control group received the usual conventional therapy *Only Conventional occupational therapy
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
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
Time Frame
before training(0week)
Title
Fugl-Meyer Assessment (FMA)
Description
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
Time Frame
after training(4week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deog Young Kim
Phone
+82-2-2228-3714
Email
KIMDY@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Phone
+82-2-2228-3714
Email
KIMDY@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients
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