UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054245 |
|---|---|
| Receipt number | R000061941 |
| Scientific Title | Investigation of the association between EEG and upper extremity assessment in patients with stroke: a prospective cohort study. |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/24 12:22:52 |
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Basic information
Public title
Investigation of the association between EEG and upper extremity assessment in patients with stroke: a prospective cohort study.
Acronym
Relationship between EEG and upper extremity function in patients with stroke.
Scientific Title
Investigation of the association between EEG and upper extremity assessment in patients with stroke: a prospective cohort study.
Scientific Title:Acronym
Relationship between EEG and upper extremity function in patients with stroke.
Region
| Japan |
Condition
Condition
stroke.
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between EEG and upper extremity assessment in patients with stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG.
Key secondary outcomes
Fugl-Meyer Assessment-Upper Extremity, EMG data of upper limb muscles.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 18 years and older
2. patients with unilateral brain lesions
3. chronic stroke (more than 90 days after the onset of stroke)
Key exclusion criteria
1. Patients with recurrent stroke.
2. Patients who have difficulty communicating due to aphasia or impaired consciousness.
3. Patients with severe higher brain dysfunction that makes it difficult to perform the evaluation.
4. Patients with severe visual or hearing impairment.
5. Patients with severe psychiatric disorders such as depression and schizophrenia.
6. Contraindications to exercise therapy are as follows;
(1) Serious cardiac diseases such as unstable angina, myocardial infarction of short duration, non-compensated congestive heart failure, acute pulmonary heart, poorly controlled arrhythmia, severe aortic valve stenosis, active myocarditis, and endocarditis.
(2) Uncontrolled hypertension.
(3) Acute systemic illness or fever.
(4) Recent pulmonary embolism, acute pulmonary heart, or severe pulmonary hypertension.
(5) Complications of serious hepatic or renal dysfunction.
(6) Complications of serious orthopedic disease that interfere with movement.
(7) Severe cognitive impairment or complications of severe psychiatric disease.
(8) Other metabolic abnormalities such as acute thyroiditis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
Homepage URL
daisuke.ito@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
EEG measurement using a headphone-type EEG and motion analysis during upper extremity evaluation will be performed at admission and discharge. For EEG measurement, a headphone-type scalp EEG device combined with dry electrodes is used to record EEG from three locations on the head. For motion analysis, video is recorded during hand EMG evaluation, which is obtained as part of the clinical evaluation.
Management information
Registered date
| 2024 | Year | 04 | Month | 24 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061941
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