Clinical trial NCT04651322: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: before training(0week)
measure: Fugl-Meyer Assessment (FMA)
timeFrame: after training(4week)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Deog Young Kim
role: PRINCIPAL_INVESTIGATOR
References: