AzTrials
AzTrials

Prosthesis UserSimultaneousNCT04272593

Pattern Recognition Prosthetic Control

A study of Prosthesis User and Congenital Amputation of Upper Limb, run by Coapt, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
16 Nov 2020to 18 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Coapt, LLC

    Chicago, Illinois, 60654

Other trials in United States

About this study

Official title: Simultaneous Pattern Recognition Control of Powered Upper Limb Prostheses

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.

Being tested
EMG-Pattern Recognition Controller
Keywords
pattern recognition, home trial, randomized cross-over trial, prosthesis, electromyography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMG-Pattern Recognition ControllerDevice

    Also called Coapt Complete Control Gen2

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

Study groups in NCT04272593
Study groupRoleWhat they receive
Simultaneous ControlExperimentalSimultaneous pattern recognition style of control allows prosthetic users to actuate more than one hand/arm function on their device at the same time.
Receives: Device: EMG-Pattern Recognition Controller
Conventional ControlActive comparatorConventional, seamless sequential pattern recognition style of control allows prosthetic users to actuate a single hand or arm functions on their device at a time.
Receives: Device: EMG-Pattern Recognition Controller

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: We will record total prosthetic wear time during the course of each 8-week period.

Secondary outcomes (3)

  1. 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.

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

  2. 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).

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start16 Nov 2020
  3. Primary completion18 Jul 2022
  4. Study completion18 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272593
Sponsor's protocol ID
120180276
Other IDs
5R44HD085306
Acronym
Simultaneous
Status last verified
Oct 2022
First submitted
13 Feb 2020
Last updated
20 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Only de-identified individual participant data collected during the study may be shared. This includes any experimental data that will underlie results in a publication such as EMG data, prosthesis usage data, virtual game data and surveys and questionnaires.

Publications

  • 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.

    PubMed 23366279

  • 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.

    PubMed 21938652

  • 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.

    PubMed 21938650

  • 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.

    PubMed 24886664

Questions about this trial

What is this clinical trial studying?

A study of Prosthesis User and Congenital Amputation of Upper Limb, run by Coapt, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in prosthetic wear time (time frame: We will record total prosthetic wear time during the course of each 8-week period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272593, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in