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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651322
• Other study ID #: 1-2019-0023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 2021

Study information

• Verified date: November 2020
• Source: Yonsei University
• Contact: Deog Young Kim
• Phone: +82-2-2228-3714
• Email: KIMDY[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• upper robot Robot assisted upper arm training(RAT)
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

Behavioral:
• Conventional therapy
The control group received the usual conventional therapy *Only Conventional occupational therapy

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)