UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028946
Receipt number R000033117
Scientific Title The analysis of gait strategy in hemiparetic gait
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/31 21:52:30

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Basic information

Public title

The analysis of gait strategy in hemiparetic gait

Acronym

The gait strategy in hemiparetic gait

Scientific Title

The analysis of gait strategy in hemiparetic gait

Scientific Title:Acronym

The gait strategy in hemiparetic gait

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the gait strategy of stroke patients and its change by using AFOs during the swing phase and the stance phase of the gait cycles.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Toe displacement and spatiotemporal parameters

Key secondary outcomes

Joint angle changes and abnormal gait indices


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


Not applicable

Gender

Male and Female

Key inclusion criteria

The presence of hemiparesis
The use of ankle foot orthosis
The ability to walk without handrail nor orthosis

Key exclusion criteria

The presence of muscular disease
The presence of orthopaedic disease
The presence of neurological disease other than stroke

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiichi Saitoh

Organization

Fujita Health University, School of Medicine

Division name

Department of Rehabilitation Medicine I

Zip code


Address

Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi

TEL

0562-93-2167

Email

mmukaino@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiko Mukaino

Organization

Fujita Health University, School of Medicine

Division name

Department of Rehabilitation Medicine I

Zip code


Address

Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi

TEL

0562-93-2167

Homepage URL


Email

mmukaino@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



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


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

2017 Year 09 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

No longer recruiting

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 04 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, the effects regarding the use of AFO was compared retrospectively.


Management information

Registered date

2017 Year 08 Month 31 Day

Last modified on

2017 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033117


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name