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

Not Applicable

• Conditions: Stroke
• Interventions: Behavioral: Conventional therapy; Device: upper robot Robot assisted upper arm training(RAT)

• Registration Number: NCT04651322
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Conventional therapy	-
Training group	upper robot Robot assisted upper arm training(RAT)	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yonsei Severance Hospital; 🇰🇷 Seoul, Korea, Republic of