UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043267
Receipt number R000049384
Scientific Title Effect of heel lift walking on soleus H-reflex in healthy adult
Date of disclosure of the study information 2021/02/10
Last modified on 2021/02/06 19:35:25

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Basic information

Public title

Effect of heel lift walking on soleus H-reflex in healthy adult

Acronym

Effect of heel lift walking on soleus H-reflex

Scientific Title

Effect of heel lift walking on soleus H-reflex in healthy adult

Scientific Title:Acronym

Effect of heel lift walking on soleus H-reflex

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine whether heel lift walking decreases soleus H-reflex compared to normal walking

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Soleus H-reflex

Key secondary outcomes

Blood pressure, Heart rate, rating of perceived exertion(RPE)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Heel lift walking(4km/h, 20min)

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

45 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult with no neurologic disease and orthopedic disease
Persons who wish to participate the present study voluntarily

Key exclusion criteria

Persons have leg pain associated with walking
Persons participate in competitive sports

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Yasunori
Middle name
Last name Umemoto

Organization

Wakayama medical university

Division name

Department of Rehabilitation Medicine

Zip code

6418509

Address

811-1 Kimiidera

TEL

0734410664

Email

yumemoto@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Minami

Organization

Wakayama medical university

Division name

Department of Rehabilitation Medicine

Zip code

6418509

Address

811-1 Kimiidera

TEL

0734410664

Homepage URL


Email

minamik@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama medical university

Institute

Department

Personal name



Funding Source

Organization

Wakayama medical university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nachikatsuura Town Onsen Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee of Wakayama Medical University

Address

811-1 Kimiidera, Wakayama 641-8509, Japan

Tel

0734472300 ext3692

Email

wa-rinri@wakayama-med.ac.jp


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

2021 Year 02 Month 10 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

Open public recruiting

Date of protocol fixation

2019 Year 07 Month 01 Day

Date of IRB

2019 Year 08 Month 07 Day

Anticipated trial start date

2019 Year 08 Month 07 Day

Last follow-up date

2024 Year 08 Month 07 Day

Date of closure to data entry

2024 Year 08 Month 07 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 02 Month 06 Day

Last modified on

2021 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049384


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name