About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Glide
- Direct Control
Treatment groups
Sponsors and collaborators
Infinite Biomedical Technologies
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Advanced Arm Dynamics
Collaborator