UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025619 |
|---|---|
| Receipt number | 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 | 2020/07/22 16:18:45 |
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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 | 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
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
konomitakahashi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University CYRIC Division of Geriatric Behavioral Neurology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029187
