UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041200 |
|---|---|
| Receipt number | 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 05:07:08 |
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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
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
y.okada@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047042
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
