Adaptive and Individualized AAC
Primary Purpose
Communication Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental AAC
Generic AAC
Sponsored by
About this trial
This is an interventional other trial for Communication Disorders focused on measuring Communication, Severe Physical Impairments, Spinal Cord Injury
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.
Sites / Locations
- Altec Inc.
- Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental and Generic Communication Interfaces for AAC
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04247828
First Posted
January 21, 2020
Last Updated
February 2, 2022
Sponsor
Altec Inc.
Collaborators
Madonna Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04247828
Brief Title
Adaptive and Individualized AAC
Official Title
Adaptive and Individualized AAC
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altec Inc.
Collaborators
Madonna Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication Disorders
Keywords
Communication, Severe Physical Impairments, Spinal Cord Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental and Generic Communication Interfaces for AAC
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Experimental AAC
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Generic AAC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Movement Time
Description
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
Title
Path-to-Target Movement Variability
Description
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
Title
Target Selection Accuracy
Description
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
Title
Information Transfer Rate
Description
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
Title
AAC Device Usability
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Contessa, PhD
Organizational Affiliation
Altec Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altec Inc.
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Facility Name
Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be made available within 6 months of study completion.
IPD Sharing Access Criteria
Data access request will be made through conferencing.
Learn more about this trial
Adaptive and Individualized AAC
We'll reach out to this number within 24 hrs