search
Back to results

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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. less than 6 months after onset of the stroke
  2. have FMA score greater than 7
  3. have confirmed that the integrity of the Corticospinal Tract (CST) is preserved in Diffusion Tensor Imaging (DTI) taken using
  4. over 20 years of age
  5. can understand and participated in study
  6. consented to this study in writing or verbally

Exclusion Criteria:

  1. quadriplegia
  2. past history of stroke
  3. past history of Musculoskeletal disease or history of Neurological diseases
  4. have a history of injury to the upper limb and upper chest, surgery, or peripheral nerve damage
  5. have skin ulcers or skin diseases such as open wounds that have difficulty applying RAT
  6. Pregnant woman
  7. 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

First Posted
November 25, 2020
Last Updated
November 25, 2020
Sponsor
Yonsei University
search

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

We'll reach out to this number within 24 hrs