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

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04651322
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 0.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: upper robot Robot assisted upper arm training(RAT); Behavioral: Conventional therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients: Randomized Controlled Trial
• Actual Study Start Date: Mar 1, 2019
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Training group	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
Other: Control group	Behavioral: Conventional therapy; The control group received the usual conventional therapy *Only Conventional occupational therapy

Outcome Measures

Primary Outcome Measures

1. Fugl-Meyer Assessment (FMA) [before training(0week)]

   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

2. Fugl-Meyer Assessment (FMA) [after training(4week)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Deog Young Kim, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT04651322
• Other Study ID Numbers: 1-2019-0023
• First Posted: Dec 3, 2020
• Last Update Posted: Dec 3, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Dec 3, 2020