UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033703
Receipt number R000037923
Scientific Title The effects of sound leg shoe-lift on hemiplegic gait - before-after study-
Date of disclosure of the study information 2018/08/09
Last modified on 2022/06/24 17:27:57

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Basic information

Public title

The effects of sound leg shoe-lift on hemiplegic gait - before-after study-

Acronym

Effects of sound leg shoe-lift on hemiplegic gait

Scientific Title

The effects of sound leg shoe-lift on hemiplegic gait - before-after study-

Scientific Title:Acronym

Effects of sound leg shoe-lift on hemiplegic gait

Region

Japan


Condition

Condition

Hemiplegia

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of the effect of sound leg shoe-lift on hemiplegic gait using objective indicators

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of variation of toe clearance (foot-to-floor distance) for swing on the paralyzed side between sound leg shoe-lift conditions

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

Device,equipment

Interventions/Control_1

Walking on a level ground with four types of sound leg shoe-lift conditions using three dimensional motion analysis and surface electromyography

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

1.Patients aged 20 years or older and under 80 years old who gave informed consent
2.Hemiplegic Patients who use orthosis and sound leg shoe-lift in daily life
3.Hemiplegic Patients who do not require assistance to walk
4.Hemiplegic Patients who can walk on level ground without using walking aid and sound leg shoe-lift

Key exclusion criteria

1.Hemiplegic Patients with severe higher brain dysfunction
2.Hemiplegic Patients with complications that influence walk such as severe orthopedic diseases

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiichi Saitoh

Organization

Fujita Health University

Division name

Department of Rehabilitation Medicine I, School of Medicine

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-2167

Email

rehabmed@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hikaru Kondo

Organization

Fujita Health University Hospital

Division name

Department of Rehabilitation

Zip code


Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-2155

Homepage URL


Email

khikaru@fujita-hu.ac.jp


Sponsor or person

Institute

Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

None

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 08 Month 09 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

Completed

Date of protocol fixation

2018 Year 08 Month 09 Day

Date of IRB

2018 Year 08 Month 09 Day

Anticipated trial start date

2018 Year 08 Month 09 Day

Last follow-up date

2022 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

2018 Year 08 Month 09 Day

Last modified on

2022 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name