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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039299
Receipt No. R000044822
Scientific Title Elucidation of "tacit knowledge" in Gait Rehabilitation of Skilled Physicians and Therapists
Date of disclosure of the study information 2020/01/29
Last modified on 2020/01/28

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Basic information
Public title Elucidation of "tacit knowledge" in Gait Rehabilitation of Skilled Physicians and Therapists
Acronym Elucidation of "tacit knowledge" in Gait Rehabilitation of Skilled Physicians and Therapists
Scientific Title Elucidation of "tacit knowledge" in Gait Rehabilitation of Skilled Physicians and Therapists
Scientific Title:Acronym Elucidation of "tacit knowledge" in Gait Rehabilitation of Skilled Physicians and Therapists
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of optimal gait rehabilitation strategies
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Walking assist data provided by the intervener through the robot
Key secondary outcomes

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 Treatment
Type of intervention
Other
Interventions/Control_1 gait rehabilitation
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Hemiplegic stroke patients with unilateral cerebral hemispheric lesions
Persons who have passed more than 3 months after the onset of stroke
Person with gait disturbance
The degree of independence in walking must be FIM 5 or higher.
To be able to understand the purpose and method of research
Key exclusion criteria Contraindications to exercise therapy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Michiyuki
Middle name
Last name Kawakami
Organization Keio University
Division name Department of Rehabilitation Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-5363-3832
Email michiyukikawakami@hotmail.com

Public contact
Name of contact person
1st name Michiyuki
Middle name
Last name Kawakami
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-5363-3832
Homepage URL
Email michiyukikawakami@hotmail.com

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address 35 Shinanomachi, Shinjuku, Tokyo
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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 01 Month 29 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
2020 Year 01 Month 28 Day
Date of IRB
2020 Year 01 Month 29 Day
Anticipated trial start date
2020 Year 02 Month 10 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

Management information
Registered date
2020 Year 01 Month 28 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044822

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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