Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Condition(s) studied

Investigational drug(s) / intervention(s)

Glide: 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: 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).

Study 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

Primary outcome measure(s)

• Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ) — Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161 and Day 168)
  CAPROQ is a validated patient reported outcome measure that captures key facets of rehabilitation for adults with UL absence or loss: perceived function, satisfaction, and pain. CAPROQ includes a total of 28 questions spread across three sub-scales: 8 satisfaction, 10 perceived functioning, and 10 pain subcategory questions. Responses to all questions are given on a 10-point, Likert-type scale. Higher scores therefore indicate higher levels of overall satisfaction. A singular total CAPROQ score is derived by standardizing each of the CAPROQ subscales and summing these standardized scores together. Higher total scores on the CAPROQ indicate better rehabilitation outcomes and reflect the individual's perceived success with their prosthesis and rehabilitation; specifically, satisfaction with their prosthesis and rehabilitation, greater functional performance, and lesser pain. CAPROQ scores range from 0 to 100.

Trial sites (1)

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