Communication Disorders
Conditions
Keywords
Communication, Severe Physical Impairments, Spinal Cord Injury
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.
Interventions
DEVICEExperimental AAC
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.
DEVICEGeneric AAC
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.
Sponsors
Madonna Rehabilitation Hospital
Altec Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Time | 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 | 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 | 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. |
| Information Transfer Rate | 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. |
| AAC Device Usability | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between January 6, 2020 and August 26, 2021.
Participants by arm
| Arm | Count |
|---|---|
| Experimental and Generic Communication Interfaces for AAC 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).
Experimental AAC: 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.
Generic AAC: 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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | covid-19 mandated patient recruitment restrictions | 9 |
Baseline characteristics
| Characteristic | Experimental and Generic Communication Interfaces for AAC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 27.3 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: 1 Day
Population: All participants (control, SPI) experienced both the Experimental AAC (Day 1) and Generic AAC (reference, Day 2) devices. Of N=30 participants, N=9 were not analyzed as they could not complete the study protocol due to COVID-19 mandated restrictions in participant recruitment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental and Generic Communication Interfaces for AAC | AAC Device Usability | Experimentanl AAC | 4.7 units on a scale | Standard Deviation 1.7 |
| Experimental and Generic Communication Interfaces for AAC | AAC Device Usability | Generic AAC | 4.3 units on a scale | Standard Deviation 2.9 |
Primary
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.
Time frame: 1 Day
Population: All participants (control, SPI) experienced both the Experimental AAC (Day 1) and Generic AAC (reference, Day 2) devices. Of N=30 participants, N=9 were not analyzed as they could not complete the study protocol due to COVID-19 mandated restrictions in participant recruitment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental and Generic Communication Interfaces for AAC | Information Transfer Rate | Experimental AAC | 45.8 Bits/min | Standard Deviation 20 |
| Experimental and Generic Communication Interfaces for AAC | Information Transfer Rate | Generic AAC | 36.6 Bits/min | Standard Deviation 16.2 |
Primary
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.
Time frame: 1 Day
Population: All participants (control, SPI) experienced both the Experimental AAC (Day 1) and Generic AAC (reference, Day 2) devices. Of N=30 participants, N=9 were not analyzed as they could not complete the study protocol due to COVID-19 mandated restrictions in participant recruitment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental and Generic Communication Interfaces for AAC | Movement Time | Experimental AAC | 2.5 Seconds | Standard Deviation 1.9 |
| Experimental and Generic Communication Interfaces for AAC | Movement Time | Generic AAC | 2.9 Seconds | Standard Deviation 2 |
Primary
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.
Time frame: 1 Day
Population: All participants (control, SPI) experienced both the Experimental AAC (Day 1) and Generic AAC (reference, Day 2) devices. Of N=30 participants, N=9 were not analyzed as they could not complete the study protocol due to COVID-19 mandated restrictions in participant recruitment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental and Generic Communication Interfaces for AAC | Path-to-Target Movement Variability | Experimental AAC | 49.7 pixels | Standard Deviation 9.4 |
| Experimental and Generic Communication Interfaces for AAC | Path-to-Target Movement Variability | Generic AAC | 74.0 pixels | Standard Deviation 9.5 |
Primary
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.
Time frame: 1 Day
Population: All participants (control, SPI) experienced both the Experimental AAC (Day 1) and Generic AAC (reference, Day 2) devices. Of N=30 participants, N=9 were not analyzed as they could not complete the study protocol due to COVID-19 mandated restrictions in participant recruitment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental and Generic Communication Interfaces for AAC | Target Selection Accuracy | Experimental AAC | 96.3 Percentage of Accurate Target Selections | Standard Deviation 6.3 |
| Experimental and Generic Communication Interfaces for AAC | Target Selection Accuracy | Generic AAC | 94.5 Percentage of Accurate Target Selections | Standard Deviation 9.8 |