Pattern Recognition Prosthetic Control

Prosthesis User Clinical Trial

— Simultaneous  

Official title:

Simultaneous Pattern Recognition Control of Powered Upper Limb Prostheses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272593
• Other study ID #: 120180276
• Secondary ID: 5R44HD085306
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: July 18, 2022

Study information

• Verified date: October 2022
• Source: Coapt, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Limb
• Congenital Amputation of Upper Limb
• Prosthesis User

Intervention

Device:
• EMG-Pattern Recognition Controller
Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device.

Locations

Country	Name	City	State
United States	Coapt, LLC	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Coapt, LLC	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in prosthetic wear time	We will record each instance participants turn on or off their pattern recognition device throughout the home trial. Prosthetic wear time is defined as the cumulative amount of time participants keep their pattern recognition device turned on during the course of each 8-week period. We will perform a statistical analysis to compare wear time when using each type of pattern recognition control (simultaneous and seamless, sequential). We will complete a repeated measures analysis of variance with subject as a random factor, order of control style used as a fixed variable, and wear time as a fixed variable.	We will record total prosthetic wear time during the course of each 8-week period.
Secondary	Differences in classification accuracy	Participants will be instructed to use their pattern recognition device to make a set of motions (either independent or simultaneous motions) and hold each motion for 3 seconds. For each motion, we will record the output motion class determined by the classifier every 50 ms. We will measure the performance of the classier for each motion by computing the classification accuracy which is defined as the number of correct classifications over the total number of classifications. We will perform a statistical analysis to compare classification accuracy when using each control type (simultaneous and seamless, sequential). We will complete a repeated measures analysis of variance with subject as a random factor, order of control style used as a fixed variable, and classification accuracy as a fixed variable.	We will record classification accuracy at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.
Secondary	RIC's Orthotics Prosthetics User Survey	Participants will complete the Upper Extremity Functional Status module from RIC's Orthotics Prosthetics User Survey (OPUS). The OPUS asks prosthetic users to rate the level of difficulty (from very easy to very difficult) in performing upper arm/hand functions using their pattern recognition device. Survey data will be evaluated using rating scale analysis (Rasch model).	Participants will complete the OPUS at the start (0-months) and end (2-months) of each 8-week period.
Secondary	Changes in virtual game performance	Participants will complete a virtual game called Simon Says using the Coapt Complete ControlRoom desktop application. Simon Says is a Fitt's Law-style test that measures how well participants control each motion using their pattern recognition device by moving a virtual arm on a screen. Participants will be instructed to match and hold the position of a virtual arm in a target position for 1 second. Participants will complete each motion (either independent or simultaneous motions) 3 times. We will measure their overall performance by computing completion rate, movement time, path efficiency. We will perform a statistical analysis to compare virtual game performance when using each type of pattern recognition control. We will complete a repeated measures analysis of variance with subject as a random factor, order of control style used as a fixed variable, and each performance metric as a fixed variable.	Participants will complete the virtual test at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.