UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051213 |
|---|---|
| Receipt number | R000057612 |
| Scientific Title | A Study on Postural Control of Hemiplegic Stroke Patients Using Network Analysis |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2024/05/31 11:51:52 |
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Basic information
Public title
Study to determine how stroke patients are able to maintain their posture
Acronym
Research on posture of stroke patients
Scientific Title
A Study on Postural Control of Hemiplegic Stroke Patients Using Network Analysis
Scientific Title:Acronym
A Study on Posture of Stroke Patients by Network Analysis
Region
| Japan |
Condition
Condition
Stroke, Healthy adults
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to capture the entire new postural control system in stroke patients, each component of muscle, COP "movement," and brain activity is considered as a subsystem, and the interactions within and between subsystems are analyzed using network analysis.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the postural control of hemiplegic stroke patients by network analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EMG data, Center-of-gravity sway data
Key secondary outcomes
Basic information such as age, gender, height, weight, degree of paralysis, degree of activity.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke patients were at least 1 month post-stroke, between 20 and 85 years of age, and standing from lightly assisted to monitored. No history of neuromuscular or orthopedic disease affecting standing in healthy subjects.
Key exclusion criteria
The patient is restricted or prohibited from standing by the attending physician, has difficulty understanding instructions, or has difficulty following instructions even if he/she can understand them.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Tomiyama |
Organization
Seijoh University
Division name
Faculty Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi Prerecture
TEL
052-601-6000
tomiyama@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Tomiyama |
Organization
Faculty Rehabilitation and Care
Division name
Seijoh University
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi Prerecture
TEL
052-601-6000
Homepage URL
tomiaiyma@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Seijoh University
Address
2-172 Fukinodai, Tokai, Aichi Prerecture
Tel
052-601-6000
sugawa@seijoh-u.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
| 2023 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 12 | 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
Stroke patients are asked to hold a standing position with a center-of-gravity sway meter while an electromyogram is attached to the paralyzed side limb. We will examine the relationship between the muscle activities and the center of gravity trajectory by using network analysis of the EMG data. We will also measure the same muscular activities in healthy adults, compare them with stroke patients, and clarify the characteristics of postural control in stroke patients.
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057612
