Trial Outcomes & Findings for Adaptive and Individualized AAC (NCT NCT04247828)

Last Updated: 2022-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

1 Day

Results posted on

2022-04-06

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study Started - Controls	19
Overall Study Started - Participants With SPI	11
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study covid-19 mandated patient recruitment restrictions	9

Baseline Characteristics

Adaptive and Individualized AAC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental and Generic Communication Interfaces for AAC n=30 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.3 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental and Generic Communication Interfaces for AAC n=21 Participants 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.
Movement Time Experimental AAC	2.5 Seconds Standard Deviation 1.9
Movement Time Generic AAC	2.9 Seconds Standard Deviation 2.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental and Generic Communication Interfaces for AAC n=21 Participants 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.
Path-to-Target Movement Variability Experimental AAC	49.7 pixels Standard Deviation 9.4
Path-to-Target Movement Variability Generic AAC	74.0 pixels Standard Deviation 9.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental and Generic Communication Interfaces for AAC n=21 Participants 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.
Target Selection Accuracy Experimental AAC	96.3 Percentage of Accurate Target Selections Standard Deviation 6.3
Target Selection Accuracy Generic AAC	94.5 Percentage of Accurate Target Selections Standard Deviation 9.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental and Generic Communication Interfaces for AAC n=21 Participants 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.
Information Transfer Rate Experimental AAC	45.8 Bits/min Standard Deviation 20.0
Information Transfer Rate Generic AAC	36.6 Bits/min Standard Deviation 16.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental and Generic Communication Interfaces for AAC n=21 Participants 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.
AAC Device Usability Experimentanl AAC	4.7 units on a scale Standard Deviation 1.7
AAC Device Usability Generic AAC	4.3 units on a scale Standard Deviation 2.9

Adverse Events

Experimental and Generic Communication Interfaces for AAC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paola Contessa

Altec Inc.

Phone: 508-545-8236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place