Tokyo, March 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060857) titled 'The Effect of Weaving Task Regularity on Subsequent Work Time: A Randomized Controlled Trial' on March 6.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - able-bodied person,person with a mental disability Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study was to clarify the effects of regular and irregular weaving tasks on subsequent work time. Specifically, the aim is to scientifically verify the cognitive and psychological effects of weaving by measuring concentration, mental stability, and the effects of repetitive movements during work. Through this, we aim to objectively demonstrate the effectiveness of weaving in occupational therapy and create a foundation for future clinical applications. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In this study, in order to examine the effects of regular tasks and irregular tasks in weaving work on subsequent work time, 40 research participants will be randomly divided into two groups: pattern A group and pattern B group. Interventions/Control_2 - When weaving, the time required, number of correct errors, and visual movements are checked. The weaving task consists of 32 sessions x 3 sessions in total (96 sessions in total), and a ``yarn exchange task'' is inserted between each session to reset the condition.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.People with no experience in weaving, 2.Right-handed people, 3.People who received sufficient explanation regarding participation in this study and gave voluntary written consent. Key exclusion criteria - 1. Diseases for which intervention poses a serious risk (unstable angina, recent myocardial infarction, severe arrhythmia, etc.). 2. When a change in condition is expected in a short period of time, such as an active serious infection or a malignant tumor undergoing treatment. 3. Difficult to obtain consent or cooperate in evaluation due to severe cognitive impairment or psychiatric symptoms (MMSE < 18, MoCA < 18, etc. Thresholds are set in the study). 4. Cases in which procedural explanation or evaluation is impossible due to severe aphasia or hearing impairment (do not rule out alternative methods if available). 5.In addition, if the attending physician determines that participation in the study is inappropriate. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069636

Disclaimer: Curated by HT Syndication.