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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04651322
Enrollment
24
Registered
2020-12-03
Start date
2019-03-01
Completion date
2021-06-30
Last updated
2020-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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

Interventions

DEVICEupper 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

BEHAVIORALConventional therapy

The control group received the usual conventional therapy \*Only Conventional occupational therapy

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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

Countries

South Korea

Contacts

Primary ContactDeog Young Kim
KIMDY@yuhs.ac+82-2-2228-3714

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026