Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060914) titled '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' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - University of Miyazaki
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Physical exercise
Interventions/Control_2 - LOCOBOT exercise
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 Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 01 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069701
Disclaimer: Curated by HT Syndication.