UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049313 |
|---|---|
| Receipt number | R000056155 |
| Scientific Title | Mechanism of Late Braking Force in Stroke patients and Pattern Classification |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/10/25 13:44:27 |
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Basic information
Public title
Mechanism of Late Braking Force in Stroke patients and Pattern Classification
Acronym
Mechanism of Late Braking Force in Stroke patients and Pattern Classification
Scientific Title
Mechanism of Late Braking Force in Stroke patients and Pattern Classification
Scientific Title:Acronym
Mechanism of Late Braking Force in Stroke patients and Pattern Classification
Region
| Japan |
Condition
Condition
hemiplegic stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To classify the mechanism and pattern of Late Braking Force appearing in the late stance in stroke patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Late Braking Force in the late stance
Key secondary outcomes
Tailing limb angle, Continuous relative phase of paretic limb, EMG waveform of paretic limb, Walking Speed, Step Lneght, Fugl Meyer Assessment
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke in the supratentorial area, paresis in one lower limb.
Ability to understand instructions for performing the gait analysis.
Ability to walk 10m without the assistance of another person or walking aides.
Key exclusion criteria
Bilateral Stroke and a history of other neurological or musculoskeletal disorders unrelated to stroke.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mizuho |
| Middle name | |
| Last name | Ohta |
Organization
Reiwa Health Sciences University
Division name
School ofr Physical Therapy
Zip code
811-0213
Address
2-1-12, wajirogaoka, Higashi-ku, Fukuoka, Japan
TEL
092-607-6701
m.ota@kyoju.ac.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Ohta |
Organization
Reiwa Health Sciences University
Division name
School ofr Physical Therapy
Zip code
811-0213
Address
2-1-12, wajirogaoka, Higashi-ku, Fukuoka, Japan
TEL
092-607-6701
Homepage URL
https://www.rhs-u.ac.jp/
m.ota@kyoju.ac.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Reiwa Health Sciences University
Address
2-1-12, wajirogaoka, Higashi-ku, Fukuoka, Japan
Tel
092-607-6701
m.ota@kyoju.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
| 2022 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The gait of stroke patients is measured using a three-dimensional motion analyzer and electromyograph.
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056155
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
