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

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 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

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

Value
https://center6.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