Clinical trial NCT04247828: Adaptive and Individualized AAC
Official title: Adaptive and Individualized AAC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication Disorders
Keywords: Communication
Severe Physical Impairments
Spinal Cord Injury
Lead sponsor: Altec Inc.
Sponsor class: INDUSTRY
Collaborators: name: Madonna Rehabilitation Hospital
First posted: 2020-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.
* 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.

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;
* 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.

Primary outcomes:
measure: Movement Time
timeFrame: 1 Day
measure: Path-to-Target Movement Variability
timeFrame: 1 Day
measure: Target Selection Accuracy
timeFrame: 1 Day
measure: Information Transfer Rate
timeFrame: 1 Day
measure: AAC Device Usability
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Natick
country: United States
facility: Altec Inc.
state: Massachusetts
city: Lincoln
country: United States
facility: Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering
state: Nebraska
Study officials:
affiliation: Altec Inc.
name: Paola Contessa, PhD
role: PRINCIPAL_INVESTIGATOR
References: