UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040337 |
|---|---|
| Receipt number | R000046030 |
| Scientific Title | Development of a quantitative evaluation of the factors associated with a difficulty of walking in hemiplegic patients |
| Date of disclosure of the study information | 2020/05/08 |
| Last modified on | 2020/05/08 17:46:57 |
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Basic information
Public title
Development of a quantitative evaluation of the factors associated with a difficulty of walking in hemiplegic patients
Acronym
Quantitative evaluation of the factors associated with a difficulty of walking in hemiplegic patients
Scientific Title
Development of a quantitative evaluation of the factors associated with a difficulty of walking in hemiplegic patients
Scientific Title:Acronym
Quantitative evaluation of the factors associated with a difficulty of walking in hemiplegic patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a quantitative evaluation of the factors that make walking difficult in hemiplegic patients
Basic objectives2
Others
Basic objectives -Others
Motion analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The indexes of gait function evaluated by three-dimensional motion analysis
Key secondary outcomes
Functional Independent Measure (FIM), Stroke Impairment Assessment Set (SIAS), gait speed, the indexes evaluated by three-dimensional gait analysis.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Recording the motion during a leg-raising task in a standing position.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient who or whose proxy gave written consent to participate in the study
2. Primary supratentorial intracerebral hemorrhage or cerebral infarction
3. Patient who can keep a standing posture by themselves using a handrail
4. Patient who can understand the tasks and follow instructions
Key exclusion criteria
1. History of stroke
2. Pregnancy or possibility of pregnancy
3. Patient who required isolation due to infections diseases
4. Patient judged unsuitable by the principal investigator or Subinvestigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University School of Medicine
Division name
Department of Rehabilitation Medicine I
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Matsuda |
Organization
Fujita Health University School of Health Sciences
Division name
Faculty of Rehabilitation
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9000
Homepage URL
fmatsuda@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Fujita Health University Institutional Review Board
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2020 | Year | 05 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 08 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046030
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
