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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030224
Receipt No. R000034525
Scientific Title The duration of imaged movement and evaluation of tempo in walking task : accuracy of imaged movement
Date of disclosure of the study information 2018/01/01
Last modified on 2017/12/02

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Basic information
Public title The duration of imaged movement and evaluation of tempo in walking task : accuracy of imaged movement
Acronym The duration of imaged movement and evaluation of tempo in walking task : accuracy of imaged movement
Scientific Title The duration of imaged movement and evaluation of tempo in walking task : accuracy of imaged movement
Scientific Title:Acronym The duration of imaged movement and evaluation of tempo in walking task : accuracy of imaged movement
Region
Japan

Condition
Condition After stroke hemiplegia, healthy youth and old age
Classification by specialty
Neurosurgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is examining the accuracy of imaged movements in walking task by the duration imaged movement and evaluation of tempo.
Basic objectives2 Others
Basic objectives -Others It is to investigate whether it is bilateral asymmetry and accurate in the imaged walking in patients with stroke hemiplegia.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The duration of imaged and actual movement in 10m walking task
The evaluation of tempo (cadence) in imaged and actual walking
The duration of imaged and actual movement in peg reversal task
Mental rotation
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy young and elderly people who gained consent of written explanation and received approval for cooperation in research. Patients who exhibit hemiplegic walking, with or without leg orthosis, can walk in straight or on straight 10m without assistance by caregivers.
Key exclusion criteria Those with nerve diseases or orthopedic diseases that restricting walking other than stroke, and those with severe high-order brain dysfunction and dementia.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yousuke Kawai
Organization The university graduate of Kobe Gakuin
Division name Department of Medical Rehabilitation, Graduate School of General Rehabilitation
Zip code
Address 518, arise, Ikawadani-cho, Nishi-ku, Kobe-shi, Hyougo-ken
TEL 09079638417
Email yosuke.pc.jp@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yousuke Kawai
Organization The university graduate of Kobe Gakuin
Division name Department of Medical Rehabilitation, Graduate School of General Rehabilitation
Zip code
Address 518, arise, Ikawadani-cho, Nishi-ku, Kobe-shi, Hyougo-ken
TEL 09079638417
Homepage URL
Email yosuke.pc.jp@gmail.com

Sponsor
Institute The university graduate of Kobe Gakuin
Institute
Department

Funding Source
Organization The university graduate of Kobe Gakuin
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
Address
Tel
Email

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 01 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, cross-sectional observation for young and elderly healthy subjects, longitudinal observation for stroke patients, evaluate the accuracy of imaged movement and find a certain tendency to increase evaluation and treatment in physical therapy.

Management information
Registered date
2017 Year 12 Month 02 Day
Last modified on
2017 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034525

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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