Adaptive and Individualized AAC

NCT04247828 | Completed Results

• 1 other identifier: AAC Phase I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Communication Disorders

Keywords

Communication; Severe Physical Impairments; Spinal Cord Injury

Outcome Measures

Primary Outcomes (5)

• Movement Time

  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.

  1 Day

• Path-to-Target Movement Variability

  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.

  1 Day

• Target Selection Accuracy

  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.

  1 Day

• Information Transfer Rate

  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.

  1 Day

• AAC Device Usability

  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.

  1 Day

Study Arms (1)

Experimental and Generic Communication Interfaces for AAC

EXPERIMENTAL

Receives both Experimental and Generic AAC systems to communicate. Each participant will receive both devices, with Experimental AAC presented first (Day 1) and Generic AAC presented second (Day 2; reference).

Device: Experimental AAC; Device: Generic AAC

Interventions

Experimental AAC DEVICE

Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptive and individualized keyboard to test communication performance.

Experimental and Generic Communication Interfaces for AAC

Generic AAC DEVICE

Participant receives an AAC system comprising a single hybrid wearable sensor for head-mediated cursor control that is integrated with a generic QWERTY keyboard to test communication performance.

Experimental and Generic Communication Interfaces for AAC

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Current or prospective AAC user with complex communication needs representing a broad spectrum of developmental and acquired SPI disabilities resulting from high spinal cord injury, chronic Guillain-Barré syndrome, brain stem stroke, cerebral palsy, locked-in syndrome, among others;
• Sufficient head control and voluntary facial muscle activation (on the basis of clinical evaluation by Dr. Susan Fager and her team) to use the proposed wearable EMG/IMU sensor for the purposes of this study;
• Evidence of at least partial voluntary head movement in at least 2 degrees of freedom (Individual differences in providing controlled movements of the head in various degrees of freedom due to their disease or trauma is not only acceptable but desirable);
• Sufficient stamina and developmental maturity (on the basis of clinical evaluation by Dr. Susan Fager) to attend to the approximately 1-hour protocol outlined in Aims 1 and 3 without excess fatigue or distraction;
• Availability for at least 3-4 testing sessions over the study period;

You may not qualify if:

• 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;
• Inability to follow simple instructions in English;
• Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) that severely limit head movement or causes pain on head movement;
• Restricted active or passive rotation of head and neck resulting from unstable vertebral, spinal cord, or nerve roots that places the subject at risk;
• Medical history of cardiac or respiratory complications, or similar disorders that would severely reduce stamina and/or 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;

Sponsors & Collaborators

• Altec Inc.: lead
• Madonna Rehabilitation Hospital: collaborator

Study Sites (2)

Altec Inc.

Natick, Massachusetts, 01760, United States

Location

Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering

Lincoln, Nebraska, 68506, United States

Location

MeSH Terms

Conditions

Communication Disorders; Communication; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavior; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Not all recruited patients could complete the study protocol due to mandated patient recruitment restrictions resulting from the covid-19 emergency.

Results Point of Contact

• Title: Dr. Paola Contessa
• Organization: Altec Inc.

pcontessa@altecresearch.com

508-545-8236

Study Officials

• Paola Contessa, PhD

  Altec Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 30, 2020
• Study Start: January 6, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: April 6, 2022
• Results First Posted: April 6, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available within 6 months of study completion.
• Access Criteria: Data access request will be made through conferencing.

Locations

US (2)