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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000026947
Receipt No. 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 2020/10/13

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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
Email 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
Email abahouse@belle.shiga-med.ac.jp

Sponsor
Institute Shiga Medical University Hospital Psychiatry Department
Institute
Department

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
Email

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 Suspended
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
2020 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030904

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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