UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030224
Receipt number 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 00:27:23

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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 or person

Institute

The university graduate of Kobe Gakuin

Institute

Department

Personal name



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

Value
https://center6.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