Health TrialsbyHealthPanel

Adaptive and Individualized AAC Phase II

ConditionCommunication Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorAltec Inc.

About this trial

The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults or Children; age greater than or equal to 6 y.o.

Male or female

Able to (a) spell, (b) follow 2-3 step directions, (c) read 40 point text

Have complex communication needs representing a broad spectrum of developmental and acquired severe motor impairments resulting from high spinal cord injury (SCI), chronic Guillain-Barre syndrome, brain stem stroke, cerebral palsy (CP), locked-in syndrome, among others.

Disqualifiers

Non-English speaker.

Inability to follow simple instructions in English.

Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) that causes pain on head, hand, or foot 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 for execution of the protocol.

Trial design

Design model

Single group

Treatments tested in this trial

  • Experimental AAC

    Device

    Participant receives an AAC system comprising 2 wearable sensors for movement-mediated cursor control and muscle activity mediated cursor selection that is integrated with an adaptive and individualized keyboard to test communication performance.

  • Generic AAC

    Device

    Participant receives an AAC system that is similar to that used to satisfy their normal daily communication needs such as an eye-tracking device with a generic AAC keyboard to test communication.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Experimental and Generic Communication Interfaces for AACExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)

Measures quantitative ratings on the TSQ-WT scale from a minimum rating of 0 to a maximum rating of 4, where the higher value means a better outcome.

Time frame
1 year
2

Information Transfer Rate

Measures the speed in meters/second of accurately moving a cursor to a specified target on a computer screen.

Time frame
1 year
3

National Aeronautics and Space Administration (NASA) Task Load Index

Measures qualitative ratings that are rated on an interval scale ranging from low (1) to high (100) of perceived user demand, performance, effort, and frustration.

Time frame
1 year

Secondary outcomes

1

Character-to-character Movement Time

Measures the duration in seconds required to move a cursor to a specified target on a computer screen.

Time frame
1 year
2

Path Efficiency

Measures the ratio of an ideal cursor path between targets to the actual path traveled.

Time frame
1 year
3

Frequency of Selecting Word Completion Options

Measures the number of times per session a predicted word is chosen in place of spelling out the individual letters of the word.

Time frame
1 year
4

Number of Written Disfluencies

Measures the number of times per session a target is substituted, inserted, or deleted as well as the number of pauses between target selections.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Altec Inc.

Lead sponsor

University of Nebraska

Collaborator

Source ClinicalTrials.gov
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