UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The duration of imaged movement and evaluation of tempo in walking task : accuracy of imaged movement
Title of the study (Brief title)	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	Yousuke Kawai
Organization	The university graduate of Kobe Gakuin
Division name	Department of Medical Rehabilitation, Graduate School of General Rehabilitation
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	Yousuke Kawai
Organization	The university graduate of Kobe Gakuin
Division name	Department of Medical Rehabilitation, Graduate School of General Rehabilitation
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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