Tokyo, July 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062138) titled 'Longitudinal changes in home-based life-space, confidence in avoiding falls, activities of daily living, life satisfaction, patient global impression of change, and falls among users of home-visit rehabilitation: a single-center prospective practice-based registry study' on July 6.

Study Type: Observational

Primary Sponsor: Institute - Tokyo General Hospital

Condition: Condition - Community-dwelling users of home-visit rehabilitation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to describe longitudinal changes in home-based life-space, activities of daily living, physical function, confidence in avoiding falls, life satisfaction, patient global impression of change, and falls among users of home-visit rehabilitation at our institution.

The primary outcome is the change in home-based life-space assessed by the Home-based Life-Space Assessment, Hb-LSA, from baseline to 6 months. We will also explore associations between changes in Hb-LSA and Barthel Index, grip strength, Functional Reach Test, single-item confidence in avoiding falls, single-item life satisfaction, Patient Global Impression of Change, and falls.

This prospective practice-based registry aims to provide fundamental data for improving assessment systems, goal setting, fall prevention, quality improvement of home-visit rehabilitation services, and future multicenter studies. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Users of home-visit rehabilitation at the study institution, including those who newly start home-visit rehabilitation during the study period Individuals living at home Individuals for whom baseline assessment is partially or fully feasible Individuals for whom neither the participant nor a proxy refuses the use of data for the study Key exclusion criteria - Individuals for whom the participant or a proxy refuses the use of data for the study Individuals for whom continued study assessment is considered clearly difficult due to terminal condition or similar reasons by the principal investigator or treating therapist Individuals for whom study assessments are considered unsafe Individuals judged by the principal investigator to be inappropriate for study inclusion Target Size - 90

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 06 Month 10 Day Date of IRB - 2026 Year 07 Month 02 Day Anticipated trial start date - 2026 Year 07 Month 06 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071105

Disclaimer: Curated by HT Syndication.