UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059251 |
|---|---|
| Receipt number | R000067772 |
| Scientific Title | The relationship between walking speed and symmetry, variability, and coordination in individuals with post-stroke hemiparesis |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/30 23:01:02 |
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Basic information
Public title
The relationship between walking speed and symmetry, variability, and coordination in individuals with post-stroke hemiparesis
Acronym
The relationship between walking speed and spatiotemporal parameters with post-stroke hemiparesis
Scientific Title
The relationship between walking speed and symmetry, variability, and coordination in individuals with post-stroke hemiparesis
Scientific Title:Acronym
The relationship between walking speed and spatiotemporal parameters with post-stroke hemiparesis
Region
| Japan |
Condition
Condition
Post-stroke hemiparetic patients
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the relationship between walking speed and symmetry, variability, and coordination in individuals with post-stroke hemiplegia
Basic objectives2
Others
Basic objectives -Others
Determinants
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gait function (walking speed, cadence, step length)
Lower limb symmetry during walking
interlimb coordination during walking
stride-to-stride variability
Key secondary outcomes
Demographics (age, gender, current medical history, past medical history)
Body composition (height, weight)
Physical function (Fugl-Meyer Assessment, Modified Ashworth Scale, Berg Balance Scale)
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
Diagnosed with stroke
Able to walk without assistance from others
Able to walk without using a wheeled walking aid
Key exclusion criteria
There is a limitation in the range of motion of the hip and knee joints on the paretic lower limb
There is a cerebellar lesion or resting tremor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-0025
Address
2-chome, Morinomiya, Joto Ward, Osaka City, Osaka, Japan
TEL
072-950-2111
iwata@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Kawamoto |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
562
Address
2-chome, Morinomiya, Joto Ward, Osaka City, Osaka, Japan
TEL
072-950-2111
Homepage URL
sf22262u@st.omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Research Ethics of the Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
2-chome, Morinomiya, Joto Ward, Osaka City, Osaka, Japan
Tel
072-950-2111
iwata@omu.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
| 2025 | Year | 10 | 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
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067772
