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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025619
Receipt No. R000029187
Scientific Title Effect of stabilizing of walking on brain activity as shown by FDG-PET
Date of disclosure of the study information 2017/01/18
Last modified on 2018/01/30

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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
Middle name
Last name Kenichi Meguro
Organization Tohoku University CYRIC
Division name Division of Geriatric Behavioral Neurology
Zip code
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
Middle name
Last name Konomi Takahashi
Organization Tohoku University CYRIC
Division name Division of Geriatric Behavioral Neurology
Zip code
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
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 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
Anticipated trial start date
2017 Year 01 Month 18 Day
Last follow-up date
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
2018 Year 01 Month 30 Day


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

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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