NCT04651322

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.3 years

First QC Date

November 25, 2020

Last Update Submit

November 25, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

Training group

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

Control group

OTHER
Behavioral: Conventional therapy

Interventions

upper robot Robot assisted upper arm training(RAT)DEVICE

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

Training group
Conventional therapyBEHAVIORAL

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

Control group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • less than 6 months after onset of the stroke
  • have FMA score greater than 7
  • have confirmed that the integrity of the Corticospinal Tract (CST) is preserved in Diffusion Tensor Imaging (DTI) taken using
  • over 20 years of age
  • can understand and participated in study
  • consented to this study in writing or verbally

You may not qualify if:

  • quadriplegia
  • past history of stroke
  • past history of Musculoskeletal disease or history of Neurological diseases
  • have a history of injury to the upper limb and upper chest, surgery, or peripheral nerve damage
  • have skin ulcers or skin diseases such as open wounds that have difficulty applying RAT
  • Pregnant woman
  • If it is judged that this clinical participation is not appropriate according to the judgment of medical doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Deog Young Kim

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deog Young Kim

CONTACT

+82-2-2228-3714KIMDY@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 3, 2020

Study Start

March 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

December 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)