Clinical trial NCT04272593: Pattern Recognition Prosthetic Control
Official title: Simultaneous Pattern Recognition Control of Powered Upper Limb Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis User
Congenital Amputation of Upper Limb
Amputation; Traumatic, Limb
Keywords: pattern recognition
home trial
randomized cross-over trial
prosthesis
electromyography
Lead sponsor: Coapt, LLC
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-02-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a randomized crossover home trial consisting of two 8-week periods with an intermittent 1-week washout period (17 weeks total). Participants will use either simultaneous control or convention seamless, sequential control in the first 8-week period followed by using the opposite control style in the second 8-week period.
Primary purpose: TREATMENT

Brief summary: This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm function at a time, simultaneous control allows for more than one at the same time. Participants will wear their prosthesis as they would normally at home using each control style for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored; including, how often participants wear their device and how many times they move each degree of freedom independently or simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous control over conventional control which will result in wearing their device more often. The secondary hypothesis is that simultaneous control will result in more efficient prosthesis control which will make it easier for participants to perform activities of daily living. The results of this study will help identify important factors related to prosthetic users' preferences while freely wearing their device within their own daily-life environment.


Eligibility criteria: Inclusion Criteria:

* Subjects have an upper-limb difference (congenital or acquired) at the transradial (between the wrist and elbow), elbow disarticulation (at the elbow), transhumeral (between the elbow and shoulder), or shoulder disarticulation (at the shoulder) level.
* Subjects are suitable to be, or already are, a Coapt pattern recognition user (Coapt Complete Control Gen2 device).
* Subjects are between the ages of 18 and 70.

Exclusion Criteria:

* Subjects with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback discussion.
* Subjects who are non-English speaking.
* Subjects who are pregnant.

Primary outcomes:
measure: Differences in prosthetic wear time
timeFrame: We will record total prosthetic wear time during the course of each 8-week period.
Secondary outcomes:
measure: Differences in classification accuracy
timeFrame: We will record classification accuracy at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.
measure: RIC's Orthotics Prosthetics User Survey
timeFrame: Participants will complete the OPUS at the start (0-months) and end (2-months) of each 8-week period.
measure: Changes in virtual game performance
timeFrame: Participants will complete the virtual test at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Coapt, LLC
state: Illinois
Study officials:
affiliation: Coapt, LLC
name: Blair Lock, MScE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chicoine CL, Simon AM, Hargrove LJ. Prosthesis-guided training of pattern recognition-controlled myoelectric prosthesis. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:1876-9. doi: 10.1109/EMBC.2012.6346318.
citation: Scheme E, Englehart K. Electromyogram pattern recognition for control of powered upper-limb prostheses: state of the art and challenges for clinical use. J Rehabil Res Dev. 2011;48(6):643-59. doi: 10.1682/jrrd.2010.09.0177.
citation: Simon AM, Hargrove LJ, Lock BA, Kuiken TA. Target Achievement Control Test: evaluating real-time myoelectric pattern-recognition control of multifunctional upper-limb prostheses. J Rehabil Res Dev. 2011;48(6):619-27. doi: 10.1682/jrrd.2010.08.0149.
citation: Wurth SM, Hargrove LJ. A real-time comparison between direct control, sequential pattern recognition control and simultaneous pattern recognition control using a Fitts' law style assessment procedure. J Neuroeng Rehabil. 2014 May 30;11:91. doi: 10.1186/1743-0003-11-91.