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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041200
Receipt No. R000047042
Scientific Title Effects of peripheral nerve electrical stimulation on anticipatory postural adjustments in gait initiation
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/23

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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