UMIN-CTR Clinical Trial

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
Email	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
Email	fmatsuda@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

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
Email	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
URL(English)	https://upload.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
Registered date	File name

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