Adaptive and Individualized AAC
Completed · Not applicable
Conditions studied: Communication Disorders
In brief
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.
Key facts
- Study ID
- NCT04247828
- Run by
- Altec Inc.
- People needed
- 30
- Starts
- 2020-01-06
- Expected to finish
- 2021-08-31
- Last updated by the study team
- 2022-04-06
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: accepted.
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;
- No medical or safety restrictions of active head and neck movement (as determined by Dr. Susan Fager in consultation with her clinical team);
- Clinical evidence of preserved cognition by a score of 0 or 1 on NIHSS Consciousness and Communication item;
- Ability to voluntarily blink eyes or raise eyebrows on command.
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;
- Unable to provide informed consent in English.
Where it is running
- Altec Inc. — Natick, Massachusetts, United States
- Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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