UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037913 |
|---|---|
| Receipt number | 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 11:43:56 |
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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
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
shiozaki@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043216
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