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Search / Trial NCT06539936

Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Launched by INFINITE BIOMEDICAL TECHNOLOGIES · Aug 2, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Amputation Upper Limb Myoelectric Control Prosthesis Glide

ClinConnect Summary

This clinical trial is studying two different types of prosthetic hands for people who have lost an arm below the elbow (trans-radial amputation). The trial compares a new prosthesis called Glide, which is designed to provide smoother movement, to a standard prosthesis known as Direct Control (DC). Researchers want to see if using the Glide prosthesis helps people perform daily tasks better, feel more satisfied with their prosthesis, and use it more often in their everyday lives.

To participate, individuals must be at least 18 years old and have lost one arm below the elbow. They should also be suitable for a special type of prosthetic hand that can move at different joints. However, people with certain conditions, such as unhealed wounds or significant cognitive or physical difficulties that could affect their participation, will not be eligible. Participants will use the standard prosthesis for about 10 to 14 weeks before switching to the Glide prosthesis for the remaining time, allowing researchers to gather information on how each type performs in real-life settings.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Trans-radial unilateral limb loss
  • Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist
  • Minimal residual limb length for myoelectric control as determined by the clinical team
  • Age of 18 years or greater
  • Exclusion Criteria:
  • 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 impacting 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.

Locations

Redondo Beach, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported