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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037913
Receipt No. R000043216
Scientific Title Effects of dynamic balance task on the vestibular spinal tract in healthy subjects
Date of disclosure of the study information 2019/10/01
Last modified on 2021/09/06

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Basic information
Public title Effects of dynamic balance task on the vestibular spinal tract in healthy subjects
Acronym Effects of dynamic balance task on the vestibular spinal tract in healthy subjects
Scientific Title Effects of dynamic balance task on the vestibular spinal tract in healthy subjects
Scientific Title:Acronym Effects of dynamic balance task on the vestibular spinal tract in healthy subjects
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Oto-rhino-laryngology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the reactivity in evaluation of vestibular spinal tract
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amplitude of H reflex
the mean velocity of movement of
the center of pressure
the envelopment area by the movement of the center of pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 dynamic balance task
Interventions/Control_2 cognitive task
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
60 years-old >
Gender Male and Female
Key inclusion criteria Participation applicant
Key exclusion criteria Persons who have medical history of dizziness, brain disease, spinal cord disease, and mental illness.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name TOMOYUKI
Middle name
Last name SHIOZAKI
Organization Nara Medical University
Division name Department of Otolaryngology- Head and Neck Surgery
Zip code 634-8522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744223051
Email shiozaki@naramed-u.ac.jp

Public contact
Name of contact person
1st name TOMOYUKI
Middle name
Last name SHIOZAKI
Organization Nara Medical University
Division name Department of Otolaryngology- Head and Neck Surgery
Zip code 634-8522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744223051
Homepage URL
Email shiozaki@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Japan Science and Technology agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JPN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Nara Medical University
Address 840 Shijo-cho Kashihara, Nara
Tel 0744223051
Email ino_rinri@naramed-u.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
2019 Year 10 Month 01 Day

Related information
URL releasing protocol http://dx.doi.org/10.17632/kbncyd8fk5.1
Publication of results Unpublished

Result
URL related to results and publications http://dx.doi.org/10.17632/kbncyd8fk5.1
Number of participants that the trial has enrolled 30
Results In healthy subjects, there was no significant change in GVSH, COP-area, or COP-velocity by performing the dynamic balance task. However, there was a significant negative correlation between changes in GVSH and COP-area pre- and post-dynamic balance task and between changes in GVSH and changes in the jerk during the task.
Results date posted
2021 Year 09 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics There were no significant differences between two groups any of these variables.
Participant flow All subjects were assigned at random to the dynamic balance task group (balance group: n = 17) or the control task group (control group: n = 13).
Adverse events no adverse effect
Outcome measures The interaction between group and time was not significant (GVSH: F (1, 26) = 0.666, p= 0.442, COP-area: F (1, 26) = 3.50, p= 0.073, COP-velocity: F (1, 26) = 0.888, p= 0.355) and there was no significant main effect of group (GVSH: F (1, 26) = 0.102, p= 0.752, COP-area: F (1, 26) = 0.095, p= 0.760, COP-velocity: F (1, 26) = 0.258, p= 0.620) or time (GVSH: F (1, 26) = 0.036, p= 0.851, COP-area: F (1, 26) = 0.736, p= 0.399, COP-velocity: F (1, 26) = 2.786, p= 0.107) on the GVSH, COP-area and COP-velocity.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 10 Month 10 Day
Anticipated trial start date
2019 Year 10 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 09 Month 03 Day
Last modified on
2021 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043216

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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