UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060914 |
|---|---|
| Receipt number | R000069701 |
| Scientific Title | A Study on the Use of Robotics and Health Exercise Programs for the Assessment of Physical Performance and Promotion of Health Among Community Residents: A Randomized Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/12 17:52:11 |
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Basic information
Public title
A Randomized Parallel-Group Comparative Study on the Use of Robotics and Health Exercise Programs for Physical Performance Assessment and Health Promotion in Community Residents
Acronym
Assessment of Physical Performance Using Robotics and Health Exercise Programs
Scientific Title
A Study on the Use of Robotics and Health Exercise Programs for the Assessment of Physical Performance and Promotion of Health Among Community Residents: A Randomized Parallel-Group Comparative Trial
Scientific Title:Acronym
Assessment of Physical Performance Using Robotics and Health Exercise Programs: A Randomized Parallel-Group Trial
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the physical performance of participants and to promote the maintenance and improvement of health, including balance ability and lower-limb muscle strength, by introducing exercise using the LOCOBOT robotic system (developed at Miyazaki University), which is operated through center-of-gravity shifting, as well as by implementing health exercise programs (Locotre).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following information will be collected directly from participants at the time of study registration and at baseline and 1, 3, 6, and 12 weeks after the start of the study.
Participant characteristics: age, sex, height, weight, body mass index (BMI), and the presence or history of musculoskeletal injuries.
Locomo Check: body balance, lower-body flexibility, upper-body flexibility, flexibility of the scapula and hip joint, and upper-body mobility.
Locomotive Syndrome Risk Test (Locomo Test): stand-up test and two-step test.
Other physical performance tests: single-leg standing test with eyes open and with eyes closed.
In addition, participants in the LOCOBOT exercise group (Group B) and the Locotre + jackknife stretch + LOCOBOT exercise group (Group C) will undergo the single-leg standing test with eyes open and closed immediately before and after the LOCOBOT exercise session at 12 weeks after the start of the study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Physical exercise
Interventions/Control_2
LOCOBOT exercise
Interventions/Control_3
Physical exercise and LOCOBOT exercise
Interventions/Control_4
Control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility Criteria
Residents of Kadogawa Town, Miyazaki Prefecture, who wish to participate in the study will be eligible.
Healthy volunteers aged 6 years or older at the time of obtaining informed consent.
Individuals with no impairment of physical function, confirmed through assessment of medical history including musculoskeletal disorders and other past illnesses.
Individuals who have received a full explanation of the study and have provided written informed consent, given voluntarily by the participant after sufficient understanding of the study; for minors, consent will also be obtained from a legally authorized representative.
Key exclusion criteria
Exclusion Criteria
Individuals with underlying medical conditions or a history of musculoskeletal surgery.
Individuals who are judged by the principal investigator to be unsuitable for participation in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Tajima |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Orthopaedic Surgery, Department of Medicine of Sensory and Motor Organas / Sports Medical Center
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985850986
ttajima@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Nishiduru |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Orthopaedic Surgery
Zip code
889-1692
Address
5200 Kihara, Kiyotake
TEL
0985850986
Homepage URL
kanako_nishiduru@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Center
Address
5200 Kihara, Kiyotake
Tel
0985859403
rinken@@med.miyazaki-u.ac.jjp
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
| 2026 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069701
