UMIN-CTR Clinical Trial

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
Institute	Wakayama medical university
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049384