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Pattern Recognition Prosthetic Control

NCT04272489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-10-20

No results posted yet for this study

Summary

Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control. Conventional control systems require frequent recalibration in order to achieve consistent performance which can lead to prosthetic users choosing to wear their device less. This study investigates a new adaptive pattern recognition control algorithm that retrains, rather than overwrite, the existing control system each instance users recalibrate. The study hypothesis is that such adaptive control system will lead to more satisfactory prosthesis control thus reducing the need for recalibration and increasing how often users wear their device. Participants will wear their prosthesis as they would normally at-home using each control system (adaptive and non-adaptive) for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored during each period in order to compare user wear time and recalibration frequency when using adaptive or non-adaptive control. Participants will also play a set of virtual games on a computer at the start (0-months), mid-point (1-months) and end (2-months) of each period that will test their ability to control prosthesis movement using each control system. Changes in user performance will be evaluated during each period and compared between the two control systems. This study will not only evaluate the effectiveness of adaptive pattern recognition control, but it will be done at-home under typical and realistic prosthetic use conditions.

Conditions

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

Interventions

DEVICE

EMG-Pattern Recognition Controller

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

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Coapt, LLC

    lead INDUSTRY

Principal Investigators

  • Blair Lock, MScE · Coapt, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2022-05-20
Completion
2022-05-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272489 on ClinicalTrials.gov