Adaptive and Individualized AAC

• Sponsor: Altec Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04247828
• Collaborator: Madonna Rehabilitation Hospital (Other)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Actual Duration (Months): 19.8
• Patients Per Site: 15
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Communication Disorders	Device: Experimental AAC; Device: Generic AAC	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Adaptive and Individualized AAC
• Actual Study Start Date: Jan 6, 2020
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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).

Device: 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.; Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altec Inc.	Natick	Massachusetts	United States	01760
2	Madonna Rehabilitation Hospital Institute for Rehabilitation Science and Engineering	Lincoln	Nebraska	United States	68506

Sponsors and Collaborators

• Altec Inc.
• Madonna Rehabilitation Hospital

Investigators

• Principal Investigator: Paola Contessa, PhD, Altec Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 29, 2021

More Information

Publications

None provided.

• Responsible Party: Altec Inc.
• ClinicalTrials.gov Identifier: NCT04247828
• Other Study ID Numbers: AAC Phase I
• First Posted: Jan 30, 2020
• Last Update Posted: Apr 6, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Altec Inc.: Communication; Severe Physical Impairments; Spinal Cord Injury
• Additional relevant MeSH terms: Communication Disorders

Study Results

Participant Flow

Recruitment Details	Participants were recruited between January 6, 2020 and August 26, 2021.

Arm/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
Period Title: Overall Study
STARTED	30
Started - Controls	19
Started - Participants With SPI	11
COMPLETED	21
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.3 (4.9)
Sex: Female, Male (Count of Participants)
Female	15 50%
Male	15 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.7%
Not Hispanic or Latino	28 93.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	6 20%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	24 80%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
Measure Participants	21
Experimental AAC	2.5 (1.9)
Generic AAC	2.9 (2.0)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
Measure Participants	21
Experimental AAC	49.7 (9.4)
Generic AAC	74.0 (9.5)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
Measure Participants	21
Experimental AAC	96.3 (6.3)
Generic AAC	94.5 (9.8)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
Measure Participants	21
Experimental AAC	45.8 (20.0)
Generic AAC	36.6 (16.2)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
Measure Participants	21
Experimentanl AAC	4.7 (1.7)
Generic AAC	4.3 (2.9)

Adverse Events

Time Frame	3 days
Arm/Group Title	Experimental and Generic Communication Interfaces for AAC
Arm/Group 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). 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.
All Cause Mortality
	Experimental and Generic Communication Interfaces for AAC
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Experimental and Generic Communication Interfaces for AAC
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Experimental and Generic Communication Interfaces for AAC
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.