UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026947 |
|---|---|
| Receipt number | R000030904 |
| Scientific Title | Relationship between improvement of stance balance function and brain activity during standing foot sole perception training using balance pad in elderly.-Comparison with young people using near infrared spectroscopy device.- |
| Date of disclosure of the study information | 2017/04/11 |
| Last modified on | 2022/10/15 20:52:47 |
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Basic information
Public title
Relationship between improvement of stance balance function and brain activity during standing foot sole perception training using balance pad in elderly.-Comparison with young people using near infrared spectroscopy device.-
Acronym
Relationship between improvement of stance balance function and brain activity during standing foot sole perception training using balance pad.-Investigation using near infrared spectroscopy device.-
Scientific Title
Relationship between improvement of stance balance function and brain activity during standing foot sole perception training using balance pad in elderly.-Comparison with young people using near infrared spectroscopy device.-
Scientific Title:Acronym
Relationship between improvement of stance balance function and brain activity during standing foot sole perception training using balance pad.-Investigation using near infrared spectroscopy device.-
Region
| Japan |
Condition
Condition
Male and female over age 60
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between young adults and those aged 60 years or older about relationship between improvement of balance function by standing foot sole perception training using balance pad and relation of brain activation area at training execution.
Basic objectives2
Others
Basic objectives -Others
In order to clarify the effect of foot sole perception training on barefoot, we examine the influence of plantar perception compared with the control task which only carries out standing balance training with wearing shoes and socks.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in each parameter (total trajectory length, unit area trajectory length, etc.) in the center of gravity swing meter, oxygenated hemoglobin change amount in each brain region in NIRS, oxygenated hemoglobin change amount in each brain region in NIRS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Standing foot sole perception training using balancing pad. (1 day of 30 seconds intervention period with 1 training and 10 times)
Interventions/Control_2
Standing balance training wearing shoes and socks.(Intervention period 1 day, 30 seconds 1 training and 10 times)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women aged 60 and over and young men and women aged 18 to 29.
Key exclusion criteria
Those who suffer from cognitive decline and those with impaired sensory function.
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Kuriyama |
Organization
Shiga University of Medical Science
Division name
Psychiatric Course
Zip code
Address
Shiga Prefecture Otsu-shi Tsunesu-cho
TEL
077-548-2111
kenichik@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Matsuno |
Organization
Shiga University of Medical Science
Division name
Psychiatric Course
Zip code
Address
Shiga Prefecture Otsu-shi Tsunesu-cho
TEL
077-548-2111
Homepage URL
abahouse@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga Medical University Hospital Psychiatry Department
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Therapy, Faculty of Medicine, Osaka Yukio Oka Medical College.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 10 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030904
