Tokyo, May 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061601) titled 'Study to Evaluate an Improved Assistive Device for One-Handed Hair Tying' on May 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Hokkaido University of Science

Condition: Condition - Upper limb functional impairment Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To improve an assistive device for one-handed hair tying and evaluate whether it improves task time and operability compared with the device used in the previous study. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will perform a one-handed hair-tying task using both the device from the previous study and the improved device. After receiving instructions and performing practice trials for each device, participants will complete the formal trials. For each trial, the total task time required to complete hair tying, the time for each procedural step, and the success rate will be recorded, and subjective evaluations will also be collected. The intervention period is one day, and each participant will perform trials with both devices on the same day. The order of device use will be adjusted as necessary.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Healthy adults aged 18 years or older Individuals affiliated with Hokkaido University of Science Individuals able to participate in the one-handed hair-tying task Individuals with no difficulty in wearing a wig and using the assistive devices Individuals who have understood the purpose and procedures of this study and have provided written informed consent Key exclusion criteria - Individuals with infectious diseases requiring systemic treatment Individuals with a body temperature of 37.0 C or higher at the time of enrollment Individuals with trauma, pain, inflammation, or other symptoms in the head, neck, or upper limbs that may interfere with the experimental task Individuals who may experience discomfort or skin problems due to wearing a wig Individuals judged to have difficulty in sufficiently understanding the study procedures and providing consent on their own free will Individuals judged by the principal investigator to be inappropriate for study participation Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 28 Day Anticipated trial start date - 2026 Year 06 Month 15 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070481

Disclaimer: Curated by HT Syndication.