UMIN-CTR Clinical Trial

Basic information
Public title	Effect of stabilizing of walking on brain activity as shown by FDG-PET
Acronym	Effect of stabilizing of walking on brain activity as shown by FDG-PET
Scientific Title	Effect of stabilizing of walking on brain activity as shown by FDG-PET
Scientific Title:Acronym	Effect of stabilizing of walking on brain activity as shown by FDG-PET
Region	Japan

Condition
Condition	Healthy elderly people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Target healthy elderly people with gait instability. It is clarified by gait analysis using an acceleration sensor that the gait becomes stable by adjusting the insole and shoe sole thickness. When the gait stabilizes, the fluctuation of the head is also reduced, and it is confirmed by FDG-PET that muscle activity and brain activity are the same as those of gait stable. From this, we aim to find out the way of walking intervention in dementia prevention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	It is confirmed that walking speed, walking strength, walking stability improve by adjusting the insole wear and thickness of the shoe sole. Image analysis is performed by FDG-PET for brain activity and whole body muscle activity when performing a walking task for 30 minutes. We perform FDG - PET shooting at a time interval of about 1 month, twice in total, walking done in an unstable state and stable walking, and compare and examine.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Other
Interventions/Control_1	We choose a group of 6 subjects judged as gait instability by the foot arch measurements of X-ray photography with the imaging radiation dose of 0.05 msv per shoot and by walking analysis by acceleration sensor. Their sugar metabolism of muscles and brains are measured by FDG-PET after 30 minutes' walk with the emphasis on instabilities of foot and legs. Subjects wear the acceleration sensor during the walk in order to conduct their gait analysis simultaneously. One month later, we measured again by FDG-PET after 30 minute's stabilized walk with the intervention of wearing insoles and adjusting thickness of the soles, Gait analysis by the acceleration sensor is conduced again as same as before. Comparative analysis is planed on the activation amounts of muscle and brain in unstable and stable gait.
Interventions/Control_2
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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Senior citizens living in the local area without central diseases, notable internal disorders or orthopedic disease. However, person with flat feet, mild X-legs and O-legs are not excluded.
Key exclusion criteria	1) Un stable symptoms with complaints of pain by orthopedic disease. 2) Those with a leg length difference of 3 cm or more. 3) Other subjects judged as inappropriate by the attending physician. 4) Those showing remarkable fatigue during walking. 5) Appealing dizziness with insole use or correction of the leg length difference. 6) Subjects with metal in the body such as pacemakers.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Meguro
Organization	Tohoku University CYRIC
Division name	Division of Geriatric Behavioral Neurology
Zip code	980-857
Address	4-1 Seiryo-mach, Aoba-ku, 980-8575 Sendaii, Japan Institute of Development, Aging and Cancer
TEL	022-717-7359
Email	k-meg@umin.ac.jp

Public contact
Name of contact person	1st name Konomi Middle name Last name Takahashi
Organization	Tohoku University CYRIC
Division name	Division of Geriatric Behavioral Neurology
Zip code	980-857
Address	4-1 Seiryo-mach, Aoba-ku, 980-8575 Sendaii, Japan Institute of Development, Aging and Cancer
TEL	022-717-7359
Homepage URL
Email	konomitakahashi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University CYRIC Division of Geriatric Behavioral Neurology
Institute
Department

Funding Source
Organization	Tohoku University CYRIC Division of Geriatric Behavioral Neurology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tohoku University
Address	1-1 Seiryo-mach, Aoba-ku, 980-8575 Sendaii, Japan
Tel	022-728-4105
Email	rinri-2@proj.med.tohoku.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	2017 Year 01 Month 18 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	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 08 Day
Date of IRB	2016 Year 12 Month 08 Day
Anticipated trial start date	2017 Year 01 Month 18 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 11 Day
Last modified on	2020 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029187