Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
Launched by INFINITE BIOMEDICAL TECHNOLOGIES · May 25, 2023
Trial Information
Current as of May 29, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the MyoTrain system, which is designed to help individuals who have lost an arm below the elbow (trans-radial limb loss) learn to control a prosthetic limb. The trial will include 16 participants who will be divided into two groups: one will receive standard training using traditional methods, while the other will use the MyoTrain system. Researchers want to see if the MyoTrain system helps people better control their prosthetics and improve their daily functioning after receiving a prosthetic limb.
To be eligible for this trial, participants must be at least 18 years old, have lost one arm below the elbow, and be suitable for a specific type of prosthetic device. Those with healing issues, significant cognitive or physical impairments, or certain medical conditions will not be able to participate. If enrolled, participants will first complete a 30-day training program, then receive their prosthetic device and therapy, followed by several assessments over the next few months to track their progress. This study aims to provide insights into how technology can improve the lives of those with limb loss.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Trans-radial unilateral limb loss
- • Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist
- • Fluent in English
- • Age of 18 years or greater
- Exclusion Criteria:
- • Prior experience with pattern recognition control
- • Patients with a residual limb that is unhealed from the amputation surgery
- • Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- • Unhealed wounds
- • Significant cognitive deficits as determined upon clinical evaluation
- • Significant neurological deficits as determined upon clinical evaluation
- • Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- • Uncontrolled pain or phantom pain impactive full participation in the study as determined upon clinical evaluation
- • Serious uncontrolled medical problems as judged by the project therapist
About Infinite Biomedical Technologies
Infinite Biomedical Technologies is a pioneering clinical trial sponsor dedicated to advancing medical innovation through the development of cutting-edge biomedical solutions. With a strong emphasis on research and development, the organization specializes in creating transformative technologies that address unmet clinical needs across various therapeutic areas. By leveraging a multidisciplinary approach and collaborating with leading experts in the field, Infinite Biomedical Technologies aims to enhance patient outcomes and improve healthcare delivery through rigorous clinical trials and evidence-based practices. Committed to ethical standards and regulatory compliance, the company strives to foster trust and transparency in all its research endeavors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Grand Rapids, Michigan, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported