UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054316 |
|---|---|
| Receipt number | R000062048 |
| Scientific Title | Gait variability indicators related to independent walking in individuals with subacute stroke. |
| Date of disclosure of the study information | 2024/05/04 |
| Last modified on | 2024/11/05 21:06:05 |
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Basic information
Public title
Gait variability indicators related to independent walking in individuals with subacute stroke.
Acronym
Gait variability indicators related to independent walking in stroke individuals.
Scientific Title
Gait variability indicators related to independent walking in individuals with subacute stroke.
Scientific Title:Acronym
Gait variability indicators related to independent walking in stroke individuals.
Region
| Japan |
Condition
Condition
Subacute stroke individuals
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. The purpose of this study is to examine which spatiotemporal gait parameter variability indicators are related to independent walking in subacute stroke individuals.
2. The purpose of this study is to show the cutoff values necessary for independent walking in the variability index of spatiotemporal parameters.
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait Variability
Walking independence
Key secondary outcomes
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.Subjects with developed hemiplegia after the first stroke.
2.Subjects within 180 days of developed.
3. Subjects with movement disorder in one lower limb.
4.Subjects were defined as being able to walk independence or with intermittent assistance (Functional Ambulation Category: FAC is 2 or more).
Key exclusion criteria
1.Subjects with severe consciousness disorder, cognitive dysfunction, or aphasia and are unable to consent to the study.
2.Subjects who are unable to walk before the onset of stroke.
3.Subjects with musculoskeletal, cardiovascular, or respiratory system diseases that impair walking.
4.Subjects requiring continuous assistance while walking (FAC < 2).
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Kikkawa |
Organization
Ushioda General Hospital
Division name
Department of Rehabilitation
Zip code
230-0001
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL
045-574-1316
mrcl.kikkawa@gmail.com
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Kikkawa |
Organization
Ushioda General Hospital
Division name
Department of Rehabilitation
Zip code
230-0001
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL
045-574-1316
Homepage URL
d245993@hiroshima-u.ac.jp
Sponsor or person
Institute
Ushioda General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ushioda General Hospital
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
Tel
045-574-1011
rihabiri@ushioda.or.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 | 05 | Month | 04 | 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
135
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To extract cutoff values for gait variability indices necessary for gait independence in stroke survivors.
Management information
Registered date
| 2024 | Year | 05 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062048
