Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInfinite Biomedical Technologies

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

7 Participants
are divided into 1 treatment group

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