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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035033
Receipt No. R000039944
Scientific Title The verification of training effect with a balance exercise assist robot on motor functions and frail
Date of disclosure of the study information 2018/11/27
Last modified on 2018/11/27

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Basic information
Public title The verification of training effect with a balance exercise assist robot on motor functions and frail
Acronym The effect of balance exercise assist robot
Scientific Title The verification of training effect with a balance exercise assist robot on motor functions and frail
Scientific Title:Acronym The effect of balance exercise assist robot
Region
Japan

Condition
Condition Frail or pre-frail elderly
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aim is the verification of training effect with a balance exercise assist robot on motor functions and frailty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Timed Up and Go test (TUG)
Key secondary outcomes FRT: Functional Reach Test
SPPB: Short Physical Performance Battery
muscle strength (grip, length)
Exercise habit
falls experience
LSA: Life Space Assessment
BDHQ: Brief-type self-administered diet history questionnaire
FES: Fall Efficacy Scale
VI: Vitality Index
GDS: Geriatrics Depression Scale
Assessment of Sarcopenia (AWGS criteria)
Blood data (TP, Alb, pre-Alb, CK, BUN, Cre)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 Robot exercise group: Balance exercise using balancing exercise assist robot (2 times / week for 2 months)
Interventions/Control_2 Physical therapy group: Muscle exercise and balance exercise (2 times / week for 2 months)
Interventions/Control_3 Exercise instruction group: Exercise guidance (once / month for 2 months)
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects are introduced to the Department of Rehabilitation, among elderly people who are visiting our Center for Locomo Frail Outpatient.
Selection criteria are elderly people aged 65 years or older who can walk independence.
Key exclusion criteria High-blood pressure(systolic blood pressure>=180 mmHg or diastolic blood pressure>=120 mmHg or resting heart rate>=120/min)
Restricted by movement due to heart function or respiratory function disorder
hearing or visual impairment
Dementia or severe higher brain dysfunction
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Izumi Kondo
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izumi Kondo
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ik7710@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization TOYOTA motors
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 11 Month 27 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 21 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
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039944

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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