Neuromusculoskeletal Interface for Bionic Arms: A Randomized Crossover Study
Shirley Ryan AbilityLab
Summary
The overall objective of this proposal is to perform a first-in-human home trial of the Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations who have had Targeted Muscle Reinnervation (TMR) surgery and use a pattern recognition-controlled myoelectric prosthesis. The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems. The investigators expect that the e-OPRA implant system will be safe and provide clinically and statistically significant improvements in control and comfort. Specifically, the investigators hypothesize that the e-OPRA system will (1) allow for training of more functional prosthesis controllers, (2) provide more stable electromyographic (EMG) signals, reducing the need to recalibrate the prosthetic control system, and (3) be more comfortable, as it does not require a tethered arm-band to record surface EMG signals. Phase 1: Perform TMR and e-OPRA surgeries in 8 persons with transhumeral amputations. Phase 2: Perform a randomized cross-over study to compare the OPRA and e-OPRA system (without sensory feedback) in 8 transhumeral amputees who have received TMR. Phase 3: Perform a randomized cross-over study to compare the e-OPRA system with and without sensory feedback in 8 transhumeral amputees who have received TMR.
Description
In the past decade, progress has been made in creating stronger, more capable prosthetic devices, with improved control. Similar improvements have been made in prosthesis suspension, which is a critically important factor in both comfort and function of a prosthetic device. While skin-fit suction sockets were considered the state of the art for many years, custom-rolled silicon and instrumented gel-liners are now becoming more common, as they provide improved comfort. However, these approaches still require use of an external socket worn on the residual limb. The Osseoanchored Prostheses for…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Between the ages of 18 and 70 years old * Unilateral transhumeral level absence * Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes). * Candidate for TMR surgery as verified by surgical team * Candidate for OPRA surgery as verified by surgical team * English speaking Exclusion Criteria: * Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the r…
Interventions
- DeviceeOPRA
Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system for transhumeral amputees.
- DeviceOPRA
Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations
- DeviceeOPRA with sensory feedback
Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations with sensory feedback.
- DeviceeOPRA without sensory feedback
Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations without sensory feedback.
Location
- Shirley Ryan AbilitylabChicago, Illinois