Tokyo, Oct. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063151) titled 'Effect of compression values in transtibial prosthetic sockets on socket interface pressure and comfort' on Oct. 2.

Study Type: Interventional

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

Primary Sponsor: Institute - Niigata University of Health and Welfare

Condition: Condition - transtibial amputee Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - For an amputee to walk comfortably with a prosthesis, the fit of the socket which houses the residual limb is crucial. There are currently no quantitative standards for adjusting parameters such as residual limb elongation and circumferential compression. Compression Value is CV during the design process instead these decisions largely rely on the experience of prosthetists. Consequently, issues such as instability due to shallow socket depth or excessive localized pressure can arise, leading to pain and poor fit. This study focuses on the interaction of "optimal CV values" tailored to the individual and aims to clarify the effects of residual limb elongation versus non-elongation on socket interface pressure distribution and Subjective Comfort Score. We believe that this research will establish fundamental data for developing quantitative standards for socket fit in CAD design, thereby providing significant benefits to both amputees and the medical professionals involved in their rehabilitation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - This study compares the effects of combining a 10 mm distal end extension with the individual's optimal compression value (CV value) on reducing local peak pressures within the socket and improving pressure distribution based on Total Surface Bearing (TSB) theory and wearing comfort.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Healthy adults with no history of orthopedic or spinal disorders. Individuals with the cognitive ability to understand the purpose and content of the study. Key exclusion criteria - Individuals with a history of orthopedic conditions who lack the cognitive ability to understand the purpose and content of the study. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 02 Day Anticipated trial start date - 2026 Year 12 Month 02 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=R000072264

Disclaimer: Curated by HT Syndication.