UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055610 |
|---|---|
| Receipt number | R000063499 |
| Scientific Title | Investigation of child locomotor function and utilization of robots for improving functionality |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2024/09/24 14:31:49 |
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Basic information
Public title
Investigation of child locomotor function and utilization of robots for improving functionality
Acronym
Investigation of child locomotor function and utilization of robots for improving functionality
Scientific Title
Investigation of child locomotor function and utilization of robots for improving functionality
Scientific Title:Acronym
Investigation of child locomotor function and utilization of robots for improving functionality
Region
| Japan |
Condition
Condition
Musculoskeletal function
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the musculoskeletal function of school-age children and to investigate the effects that exercise using LOCOBOT (developed by Miyazaki University), a robot system that operates a robot by shifting the center of gravity, has on improving musculoskeletal function, such as balance ability and lower limb strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements will be conducted five times during the 12-week intervention period. The times are at weeks 0, 1, 3, 6, and 12.
The items measured are as follows:
Body balance ability
Lower body flexibility
Upper body flexibility
Scapular and hip flexibility
Upper body range of motion
Stand-up test
Two-step test
Muscle tightness
Center of gravity sway measurement
Open and closed eyes one-legged stand test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is 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
| Device,equipment | Behavior,custom |
Interventions/Control_1
Child-Locomo-Exercises + Jackknife Stretch Group
Do Child-Locomo-Exercises and Jackknife Stretch three times a day.
Participate in measurement sessions on weeks 0, 1, 3, 6, and 12.
The intervention period was 12 weeks.
Interventions/Control_2
LOCOBOT exercise Group
Do LOCOBOT exercise once a week.
Participate in measurement sessions on weeks 0, 1, 3, 6, and 12.
The intervention period was 12 weeks.
Interventions/Control_3
Child-Locomo-Exercises + Jackknife Stretch + LOCOBOT exercise Group
Do Child-Locomo-Exercises and Jackknife Stretch three times a day.
Do LOCOBOT exercise once a week.
Participate in measurement sessions on weeks 0, 1, 3, 6, and 12.
The intervention period was 12 weeks.
Interventions/Control_4
Control group
Participate in measurement sessions on weeks 0, 1, 3, 6, and 12.
The intervention period was 12 weeks.
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers aged 6 years or older at the time of consent.
Subjects who have received a sufficient explanation of the study, fully understood the study, and given their own voluntary consent or written consent from a legal representative.
Key exclusion criteria
Subjects with underlying diseases or history of musculoskeletal surgery.
Subjects who the research director judges to be inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Tajima |
Organization
University of Miyazaki
Division name
Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara Kiyotakecho Miyazaki City, Miyazaki
TEL
0985-85-1510
ttajima@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Tajima |
Organization
University of Miyazaki
Division name
Faculty of Medicine
Zip code
8889-1692
Address
5200 Kihara Kiyotakecho Miyazaki City, Miyazaki
TEL
0985-85-1510
Homepage URL
ttajima@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Musculoskeletal Medicine
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara Kiyotakecho Miyazaki City, Miyazaki
Tel
0985-85-9403
rinken@med.miyazaki-u.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
| 2025 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063499
