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Clinical Trials/NCT04247828
NCT04247828
Completed
Not Applicable

Adaptive and Individualized AAC

Altec Inc.2 sites in 1 country30 target enrollmentJanuary 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Communication Disorders
Sponsor
Altec Inc.
Enrollment
30
Locations
2
Primary Endpoint
Movement Time
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This project will test the feasibility of developing a smart augmentative or alternative communication (AAC) system that is effective in delivering communication capabilities that automatically adapt to the users' physical abilities.

Detailed Description

The diversity of the more than 1.3% of Americans who suffer from severe physical impairments (SPIs) preclude the use of common augmentative or alternative communication (AAC) solutions such as manual signs, gestures or interaction with a touchscreen for communication. This clinical trial will test the feasibility of developing a smart-AAC system designed using individually adaptive access methods and AAC interfaces to accommodate the unique manifestations of motor impairments specific to each user. The investigators will demonstrate the proof-of-concept that a single surface electromyographic (sEMG) and inertial measurement unit (IMU) hybrid sensor worn on the forehead can provide improvements in information transfer rate (ITR) and communication accuracy when integrated with an AAC interface that is optimized compared to a conventional (non-adaptable) interface for subjects with SPI.

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
August 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Altec Inc.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Control Subjects:
  • Adults and Children; \>12yo
  • Male or Female
  • All participants will be: (a) able to spell, (b) able to follow 2-3 step directions, (c) have functional vision sufficient to read 40 point text
  • No history of communication disorders;
  • No history of neurological disorders affecting speech or head movement.
  • Subjects with SPI:
  • Adults or Children; age\>12yo
  • Male or Female
  • All participants will be: (a) able to spell, (b) able to follow 2-3 step directions, (c) have functional vision sufficient to read 40 point text, and (d) have a motor impairment that requires the use of an alternative access strategy to communicate and/or use technology.

Exclusion Criteria

  • Control Subjects
  • Non-English speaker;
  • Inability to follow simple instructions in English;
  • Restricted ROM of the head or neck;
  • Pain with head movement
  • Medical history of cardiac or respiratory complications, or disorders that would place the subject at risk for conducting the different motor activities;
  • Skin disorders that result in open lesions or hyper-sensitive/fragile skin on the forehead, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
  • Unable to provide informed consent in English.
  • Subjects with SPI
  • Non-English speaker;

Outcomes

Primary Outcomes

Movement Time

Time Frame: 1 Day

Time needed to navigate a cursor to and select a target on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein lower movement times equate to better performance.

Path-to-Target Movement Variability

Time Frame: 1 Day

Path smoothness relative to the optimal, straight path between targets on a computer screen by control of head movement and facial muscle contractions for each AAC device. Variability is estimated as a distance of pixels as estimated from a computer screen operating with a resolution of 1920 pixels x 1080 pixels, wherein smaller variability scores equate to better performance.

Target Selection Accuracy

Time Frame: 1 Day

Percentage of accurate selections of targets on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher accuracy scores equate to better performance.

AAC Device Usability

Time Frame: 1 Day

Self-report of perceived AAC device usability as captured via a Likert scale anchored from 1 ("very difficult") to 7 ("very easy"), wherein higher usability scores equate to better performance.

Information Transfer Rate

Time Frame: 1 Day

Human motor performance relative to the speed and accuracy of cursor-to-target movements on a computer screen by control of head movement and facial muscle contractions for each AAC device, wherein higher information transfer rates equate to better performance.

Study Sites (2)

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