Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Infinite Biomedical Technologies
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.
Description
Recruitment and group assignment: Participants will be recruited through one of Arm Dynamics's six Centers of Excellence. Potentially eligible participants will be identified by their care team and referred to a study team member to go over the details of the patient's involvement and the study protocol. After informed consent and medical clearance are completed, the study prosthetist and occupational therapist will meet with the participant and identify functional goals for their prosthesis. The prosthetist will then begin fabricating the prosthesis. A single prosthesis will be fabricated for…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 determ…
Interventions
- DeviceGlide
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.
- DeviceDirect Control
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).
Location
- Advanced Arm DynamicsRedondo Beach, California