Pattern Recognition Prosthetic Control

NCT04272593 | Completed FDA Device

• 2 other identifiers: 1201802765R44HD085306
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pattern recognition; home trial; randomized cross-over trial; prosthesis; electromyography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Differences in classification accuracy

  We will record classification accuracy at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.

• RIC's Orthotics Prosthetics User Survey

  Participants will complete the OPUS at the start (0-months) and end (2-months) of each 8-week period.

• Changes in virtual game performance

  Participants will complete the virtual test at the start (0-months), mid-point (1-months) and end (2-months) of each 8-week period.

Study Arms (2)

Simultaneous Control

EXPERIMENTAL

Simultaneous pattern recognition style of control allows prosthetic users to actuate more than one hand/arm function on their device at the same time.

Device: EMG-Pattern Recognition Controller

Conventional Control

ACTIVE COMPARATOR

Conventional, seamless sequential pattern recognition style of control allows prosthetic users to actuate a single hand or arm functions on their device at a time.

Device: EMG-Pattern Recognition Controller

Interventions

EMG-Pattern Recognition Controller DEVICE

Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device.

Also known as: Coapt Complete Control Gen2

Conventional Control; Simultaneous Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coapt, LLC: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Coapt, LLC

Chicago, Illinois, 60654, United States

Location

Related 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.

  PMID: 23366279 BACKGROUND

• 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.

  PMID: 21938652 BACKGROUND

• 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.

  PMID: 21938650 BACKGROUND

• 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.

  PMID: 24886664 BACKGROUND

Study Officials

• Blair Lock, MScE

  Coapt, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: November 16, 2020
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: We expect study data and results to become available at the end of the study upon completing data analysis and publication.
• Access Criteria: It is at the discretion of authorized study personnel with whom data will be shared or where it may be made available. Only de-identified data will be shared using standard data file formats (.csv or .txt). Data may be shared with the research community at large to advance science and health. Data will be publicly available via an online data sharing website only if required for publication in a scientific journal. Upon data analysis completion, study results may be shared with subjects and will be disseminated to the public in the form of a journal publication. Study results may also be posted on the Coapt website.

Locations

US (1)