Tokyo, May 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061714) titled 'Prosthesis for congenital transverse failure' on May 28.

Study Type: Interventional

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

Primary Sponsor: Institute - National Center for Child Health and Development

Condition: Condition - Congenital transverse failure Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Congenital transverse failure causes not only cosmetic problems but also functional, postural, and skeletal impairments, including scoliosis and limitations in daily and cultural activities. Because regeneration of a normal upper limb is currently impossible, myoelectric prostheses are considered a promising means of replacing lost motor and sensory functions. Therefore, this study aims to establish non-invasive measurement and signal-processing technologies for myoelectric prostheses controlled by surface electromyographic signals, thereby providing a technological foundation for future functional upper-limb replacement. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - For patients with congenital transverse failure, individualized prostheses will be fabricated and fitted according to each case. Functional evaluations will be performed during the initial period after fitting and then every six months for approximately three years.

Eligibility: Age-lower limit - 1 years-old = Gender - Male and Female Key inclusion criteria - Patients diagnosed with congenital transverse failure (including transradial and transhumeral deficiencies) who provide written informed consent for participation in this study. Key exclusion criteria - Patients with intellectual or developmental disabilities, as well as those deemed unsuitable for participation at the discretion of the investigator. Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2014 Year 06 Month 02 Day Date of IRB - 2014 Year 06 Month 02 Day Anticipated trial start date - 2014 Year 06 Month 02 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=R000070622

Disclaimer: Curated by HT Syndication.