Clinical Trial: The relationship between mobility support using application tools and self-efficacy for people with visuospatial cognitive impairment: A randomized controlled trial (Japan)

Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058766) titled 'The relationship between mobility support using application tools and self-efficacy for people with visuospatial cognitive impairment: A randomized controlled trial' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Shonan University of Medical Sciences

Condition: Condition - Cognitive impairment after brain injury Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify whether the use of the LOOVIC application tool contributes to improving self-efficacy in community residents with visuospatial cognitive impairment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention period: 4 weeks Follow-up period: 3 months later, 6 months later Blinding: Single-blind Intervention group: Outdoor support using the LOOVIC application tool Each period consisted of one 40-minute intervention session per week. Interventions/Control_2 - Intervention period: 4 weeks Follow-up period: 3 months later, 6 months later Blinding: Single-blind Control group: Regular outdoor support (therapist provides guidance) Each period consisted of one 40-minute intervention session per week.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Individuals with visuospatial cognitive impairment due to brain damage Aged 20 to 79 Individuals living at home with a clear level of consciousness and an MMSE-J score of 24 or higher Individuals who can walk outdoors independently Individuals who can give their consent to participate in the study Key exclusion criteria - Those under 20 years of age or over 80 years of age Those with a history of dementia or mental illness Those who live alone Those with severe aphasia who have difficulty understanding the questionnaire Those with apraxia Those with hearing abnormalities (hearing loss, deafness, etc.) Those who cannot give their consent to participate in the study Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 15 Day Date of IRB - 2025 Year 07 Month 15 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067195

Disclaimer: Curated by HT Syndication.