UMIN-CTR Clinical Trial

Basic information
Public title	Effects of peripheral nerve electrical stimulation on anticipatory postural adjustments in gait initiation
Acronym	peripheral nerve electrical stimulation for anticipatory postural adjustments in gait initiation
Scientific Title	Effects of peripheral nerve electrical stimulation on anticipatory postural adjustments in gait initiation
Scientific Title:Acronym	peripheral nerve electrical stimulation for anticipatory postural adjustments in gait initiation
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of peripheral nerve electrical stimulation of the common peroneal nerve on anticipatory postural adjustments in gait initiation in healthy subjects
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Latency and amplitude of electromyography of tibial anterior and soleus, displacements and velocity of center of pressure (COP), distance between COP and center of mass in postural phase of gait initiation
Key secondary outcomes	Motor-evoked potential in tibial anterior musucle

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Peripheral nerve electrical stimulation
Interventions/Control_2	Sham stimulation
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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy young subjects
Key exclusion criteria	History of central nervous system diseases and orthopedic diseases
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Okada
Organization	Kio University
Division name	Department of Physical Therapy, Faculty of Health Science
Zip code	635-0832
Address	4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL	+81-745-54-1601
Email	y.okada@kio.ac.jp

Public contact
Name of contact person	1st name Yohei Middle name Last name Okada
Organization	Kio University
Division name	Department of Physical Therapy, Faculty of Health Science
Zip code	635-0832
Address	4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL	+81-745-54-1601
Homepage URL
Email	y.okada@kio.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	None
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	Kio University Research Ethics Committee
Address	4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
Tel	+81-745-54-1601
Email	soumu@kio.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	畿央大学（奈良県）

Other administrative information
Date of disclosure of the study information	2020 Year 08 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	2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 01 Month 01 Day
Date trial data considered complete	2022 Year 01 Month 01 Day
Date analysis concluded	2022 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2020 Year 07 Month 23 Day
Last modified on	2020 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047042