UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047424 |
|---|---|
| Receipt number | R000054082 |
| Scientific Title | Physical characteristics associated and reference values of gait variability in subacute stroke hemiplegic individuals. |
| Date of disclosure of the study information | 2022/04/07 |
| Last modified on | 2023/04/07 16:13:24 |
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Basic information
Public title
Physical characteristics associated and reference values of gait variability in subacute stroke hemiplegic individuals.
Acronym
Physical characteristics associated and reference values for gait variability in stroke individuals.
Scientific Title
Physical characteristics associated and reference values of gait variability in subacute stroke hemiplegic individuals.
Scientific Title:Acronym
Physical characteristics associated and reference values for gait variability in stroke individuals.
Region
| Japan |
Condition
Condition
Subacute stroke hemiplegic individuals.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. The purpose of this study is to present the reference value of gait variability according to the walking ability in subacute stroke hemiplegic individuals.
2. The purpose of this study is to examine the physical factors associated with gait variability in subacute stroke hemiplegic individuals.
Basic objectives2
Others
Basic objectives -Others
observational cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stride time variability (Coefficient of Variation)
Key secondary outcomes
Age, Use of cane and orthotics, FMA-UE, FMA-LE, FMA-balance, FMA-sensation, FMA-Passive joint motion, FMA-Joint pain, Trunk control test, modified ashworth scale of the ankle joint, Knee joint extension muscle strength, Mini Mental State Examination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects with developed hemiplegia after the first stroke.
2.Subjects within 60 days of developed.
3.Subjects with do not need assistance to walk.
4. Subjects with intermittently require the assistance of only one person for walking.
Key exclusion criteria
1.Subjects with impaired consciousness.
2.Subjects with cognitive decline, aphasic symptoms, higher brain dysfunction that are difficult to understand in this study.
3. Subjects who are unable to walk before the onset of stroke.
4.Subjects with cardiovascular or respiratory disease that limit training.
5.Subjects with lower limb osteoarthritis that limit training.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kikkawa |
| Middle name | |
| Last name | Taishi |
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 | Kikkawa |
| Middle name | |
| Last name | Taishi |
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
mrcl.kikkawa@gmail.com
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
| 2022 | Year | 04 | Month | 07 | 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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Factors validating the association
FMA-UE, FMA-LE, FMA-balance, FMA-sensation, FMA-Passive joint motion, FMA-Joint pain, Trunk control test, modified ashworth scale of the ankle joint, Knee joint extension muscle strength, Mini Mental State Examination
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054082
