UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030904