UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035033 |
|---|---|
| Receipt number | 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 | 2022/09/16 20:33:38 |
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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 | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Rehabilitation Center
Zip code
474-8511
Address
7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Rehabilitation Center
Zip code
474-8511
Address
7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
The clinical research ethics committee in National Center for Geriatrics and Gerontology
Address
7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
Tel
0562-46-2311
rehab@ncgg.go.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
| 2018 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/re/reports/detail/1037
Publication of results
Partially published
Result
URL related to results and publications
https://jrct.niph.go.jp/re/bulletins/detail/932/4503
Number of participants that the trial has enrolled
79
Results
The results of the interim analysis suggest that muscle strength and some balance ability can be However, the results of the interim analysis also suggested that the home-based exercise program However, the number of times of voluntary exercise at home, which was also taught, tended to decrease gradually from the time of the start of the program, leaving some issues to be solved for the long-term establishment of voluntary exercise.
Results date posted
| 2022 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
To date, 79 patients (mean age 78.5+-6.1 years, 28 males/51 females, BEAR group: 28, outpatient rehabilitation group: 26, exercise instruction group: 25) have been entered and the intervention was implemented.
Participant flow
Elderly patients who visit the outpatient locomotor frailty clinic at our center and who are referred to the Department of Rehabilitation Medicine are eligible for this study. Selection criteria are as follows: elderly patients aged 65 years or older, regardless of gender, capable of independent walking, and informed consent has been obtained.
Adverse events
none.
Outcome measures
Primary endpoints Postural balance ability (Timed Up and Go test: TUG) Secondary endpoints Postural balance ability, lower limb muscle strength, (Functional Reach Test: FRT, Short Physical Performance Battery: SPPB, and Knee Extensor Strength), Exercise Habits (Exercise Time and Frequency as recorded in the Self-Training Checklist), Falls Survey (no falls in the past year at the start of the study, no falls during the study period as recorded in the Health Handbook), Life Span Assessment (LSA), Nutritional Assessment (BDHQ: Brief- type self-administered diet history questionnaire), fear of falling (FES: Fall Efficacy Scale), motivation and affect (Vitality Index: VI, Geriatrics Depression Scale: GDS), and SarcoEvaluation of penia (limb skeletal muscle mass by BIA method, 10 m), comfortable walking speed, grip strength), general biochemical data (blood volume drawn: 14 ml per test; TP, Alb, pre-Alb, CK, BUN, Cre)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since this study falls under the category of specific clinical research, we will continue to disclose information on the progress of the study on jRCT.
https://jrct.niph.go.jp/re/reports/detail/1037
Management information
Registered date
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039944
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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