Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Infinite Biomedical Technologies
7 participants
Sep 16, 2024
INTERVENTIONAL
Conditions
Summary
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis. This study will compare the use of Glide \[Experimental\] prosthesis with a DC \[Standard\] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
Glide is a myoelectric prosthesis control strategy which enables multifunctional control using a limited set of input EMG signals (as few as two). The Glide control strategy uses the relative contributions of multiple electrode inputs to create a virtual cursor, calculated from a vector summation of multiple EMG channels, to select the type and speed of a movement from a circular map.
Direct Control (DC) is the most common method of control for powered prostheses, which directly links the activity recorded from a single electromyography (EMG) electrode to a prosthesis action. Typically, a pair of EMG electrodes are placed over a pair of agonist/antagonist muscle groups to operate a single DOF (e.g., for transradial amputees the flexor muscles in the forearm may be mapped to the prosthetic hand closing and the forearm extensor muscles mapped to hand opening).
Locations(1)
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NCT06539936