Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Launched by INFINITE BIOMEDICAL TECHNOLOGIES · Aug 2, 2024

Keywords

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