Evaluation of Functional Performance of Persons With Limb Differences to Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
Liberating Technologies, Inc.
Summary
The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years or older with upper limb absence at the transradial level while wearing a physical prosthesis. The specific aims of this study are: 1. To evaluate the effect of changing untargeted myoelectric channel count on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test. 2. To evaluate the effect of changing myoelectric channel targeting of a fixed number of myoelectric channels on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test. Researchers will perform a randomized crossover study to compare system configurations with different number of sensor channels and with various strategies for sensor placement on the limb. Participants will be assigned to a random test sequence that includes the following four different EMG channel conditions: Condition A: 4 untargeted channels Condition B: 8 untargeted channels Condition C: Up to 16 untargeted channels Condition D: 8 targeted channels Researchers will evaluate the effects of changing myoelectric channel counts on the functional prosthesis performance of individuals with transradial limb loss via functional outcome measures. Participants will: * Attend up to 5 in-lab sessions that are expected to last 4 hours. * Conduct site visits every 1-2 weeks to complete functional and self reported outcome measures with each condition. * Play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits.
Description
The objective of this study is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control, that have been established nearly exclusively on offline data analysis from able-bodied subjects, translates to functional performance when tested on persons with upper limb difference wearing a physical prosthesis. The two prior assumptions that will be evaluated are: 1) there is no advantage to targeting myoelectric channels to specific muscle sites, and 2) there is no advantage to using more than 4-6 myoelectric channels for trans-radial prosth…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Unilateral transradial level limb absence * Current or past user of myo-electric controlled prostheses * Six months or more post-amputation * Have adequate limb length such that a wrist rotation device can fit in the check socket * Well-fitting socket as determined by a Socket-Comfort Score of 6 or above * Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand * Capable of understanding and following multi-step instructions and completing the tasks as described * English speaking Exclusion Criteria: * Significant new injury that…
Interventions
- DeviceExperimental socket with 4 untargeted channels active
Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. Only 4 channels will be active during this condition.
- DeviceExperimental socket with 8 untargeted channels active
Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. Only 8 channels will be active during this condition.
- DeviceExperimental socket with up to 16 untargeted channels active
Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. All16 channels (or the maximum number of channels based on limb size) will be active during this condition.
- DeviceExperimental socket with 8 targeted channels active
Participants will utilize the experimental socket made with targeted EMG channels. This socket will follow Coapt's clinical instructions for targeted site location to identify and mark locations for 8 targeted EMG channels.
Locations (2)
- Shirley Ryan AbilityLabChicago, Illinois
- Liberating Technologies, Inc.Holliston, Massachusetts