UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033329 |
|---|---|
| Receipt number | R000037993 |
| Scientific Title | Kinematic characteristics of free-living gait and posture |
| Date of disclosure of the study information | 2018/07/09 |
| Last modified on | 2024/04/01 23:58:32 |
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Basic information
Public title
Kinematic characteristics of free-living gait and posture
Acronym
Kinematic characteristics of free-living gait and posture
Scientific Title
Kinematic characteristics of free-living gait and posture
Scientific Title:Acronym
Kinematic characteristics of free-living gait and posture
Region
| Japan |
Condition
Condition
Spinal / lower limb orthosis disease/stroke
Classification by specialty
| Neurology | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
explore the impact of environment and pathology by analysing movement of people in the laboratory and free-living environments
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic indexs of gait in free-living
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) hemorrhagic or ischemic stroke diagnosis confirmed based on CT or MRI imaging, (2) walking independently with or without a cane in a free-living environment, (3) stroke onset within six months; and (4) no known history of stroke.
Key exclusion criteria
Those who can not understand and attach of the accelerometers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Kio University
Division name
Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragi-gun Nara
TEL
0745-54-1601
index2424@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Kio University
Division name
Health Sciences
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragi-gun Nara
TEL
0745-54-1601
Homepage URL
index2424@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragi-gun Nara
Tel
095-819-7967
index2424@gmail.com
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
| 2018 | Year | 07 | Month | 09 | 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
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Accelerometers are attached to the low back and thigh and measured in dairy life and in the laboratory,
Management information
Registered date
| 2018 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037993
