- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04651322
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
- 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Seoul, Korea, Republikken
- Rekruttering
- Yonsei Severance Hospital
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Kontakt:
- Deog Young Kim
- Telefonnummer: +82-2-2228-3714
- E-mail: KIMDY@yuhs.ac
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Kontrolgruppe
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The control group received the usual conventional therapy *Only Conventional occupational therapy
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Eksperimentel: Træningsgruppe
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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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fugl-Meyer Assessment (FMA)
Tidsramme: 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
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before training(0week)
|
Fugl-Meyer Assessment (FMA)
Tidsramme: 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
|
after training(4week)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1-2019-0023
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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