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Cerebral PalsyAIinAACNCT06599996

Artificial Intelligence and Augmentative and Alternative Communication AAC

A study testing Testing artificial intelligence algorithms for interpreting gestures in people with Cerebral Palsy and Cortical Visual Impairment, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overarching objective of this project is to transform access to assistive communication technologies (augmentative and alternative communication) for individuals with motor disabilities and/or visual impairment, for whom natural speech is not meeting their communicative needs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Palsy, Cortical Visual Impairment
What is being tested?
Testing artificial intelligence algorithms for interpreting gestures
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
24 Sep 2024to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have motor impairment, which can present in diverse/multiple ways, including spasticity, ataxia, or dystonia (these types of movement disorders are different from one another, and can result from diverse genetic conditions or injury to the brain before or shortly after birth, and generally all fall under the umbrella term cerebral palsy or movement disorder). Note: Presence of intellectual disability in addition to motor disability is not an exclusionary criteria, meaning that we will include both individuals with intact intellectual ability as well as those with intellectual disability
  • Can/will tolerate a small biosensor (about the size of a medallion) attached to a limb (for instance, wrist or elbow) embedded within a soft wrist band

Who cannot join

  • Do not have motor disabilities
  • Cannot tolerate a small biosensor (about the size of a medallion) attached to a limb (for instance, wrist or elbow) with a soft wrist band

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Pennsylvania State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: Application of Artificial Intelligence to Improve Access to Augmentative and Alternative Communication

The overarching objective of this project is to transform access to assistive communication technologies (augmentative and alternative communication) for individuals with motor disabilities and/or visual impairment, for whom natural speech is not meeting their communicative needs. These individuals often cannot access traditional augmentative and alternative communication because of their restricted movement or visual function. However, most such individuals have idiosyncratic body-based means of communication that is reliably interpreted by familiar communication partners. The project will test artificial intelligence algorithms that gather information from sensors or camera feeds about these idiosyncratic movement patterns of the individual with motor/visual impairments. Based on the sensor or camera feed information, the artificial intelligence algorithms will interpret the individual's gestures and translate the interpretation into speech output. For instance, if an individual waves their hand as their means of communicating "I want", the artificial intelligence algorithm will detect that gesture and prompt the speech-generating technology to produce the spoken message "I want." This will allow individuals with restricted but idiosyncratic movements to access the augmentative and alternative communication technologies that are otherwise out of reach.

Read the detailed description

As noted in the Communication Bill of Rights from the National Joint Committee on the Communication Needs of Persons with Severe Disabilities, "All people with a disability of any extent or severity have a basic right to affect, through communication, the conditions of their existence." Access to speech-language therapies that promote optimal communication outcomes is also noted to be a fundamental right by the United Nation's Article 19 of the Convention on the Rights of Persons with Disabilities. Yet many individuals with physical or intellectual disabilities have language limitations that prevent them from using speech as their primary mode of communication. For these individuals, assistive communication technologies (augmentative and alternative communication) offer an important set of supports for realizing this critical human right.

Although augmentative and alternative communication is widely-used and evidence-based, there are particular challenges in designing augmentative and alternative communication for individuals with visual and concomitant motor impairments. Unlike spoken language, in much of aided augmentative and alternative communication the vocabulary items are visual (letters, words, symbols) and only a limited number of items can be displayed at a time, since they must be presented on an external device (such as a tablet or a dedicated device). To maximize available vocabulary, clinicians often place many symbols onto the small display. Although this strategy can be useful for some people - and does maximize vocabulary visible on any given page - it is a substantial problem for individuals with visual impairments who cannot either see (ocular) or process (cortical) the visual information. In addition, access to these vocabulary items often involves use of a finger or eye gaze to select a symbol or a limb to activate a switch. These types of repetitive selections may be difficult and fatiguing for individuals with motor disabilities. As a consequence, traditional methods of accessing augmentative and alternative communication that work for other individuals are selectively more difficult for those with visual impairment and motor disabilities. There is an urgent need to develop augmentative and alternative communication technologies that reduce the visual and motoric burden for such individuals.

This project seeks to substantially increase the flexibility of aided augmentative and alternative communication access in part through a reconsideration of the traditional distinction made between aided (i.e., technology assisted) and unaided (i.e., body-based) communication modes. Aided communication modes offer the power of symbolic communication that is readily understood by many communication partners, even those who are unfamiliar with the individual using augmentative and alternative communication. However, aided modes can be quite limiting in terms of the vocabulary available, speed of message preparation, environmental constraints, and ability to support natural conversations. Unaided communication modes, on the other hand, can involve a diverse range of natural movements that are well within the skill set of the user, and can be rapidly produced with low effort. The drawback of unaided modes is that they are often difficult for unfamiliar partners to understand, thus limiting the range of potential communication partners and necessitating the proximity of a communication partner to the augmentative and alternative communication user to observe the body-based communication.

Given contemporary technology, it is both theoretically and practically possible to substantially increase access to aided augmentative and alternative communication by leveraging the ability of technology to sense and interpret unaided input ranging from natural air gestures to facial expressions and/or other intentional movement patterns. Harnessing unaided inputs as a supplemental means for access to technology will marry the power of the aided symbolic communication with the ease, speed, and unique movements employed by individual users. In so doing, it will shift the burden of access from the user (at least in part) onto the aided augmentative and alternative communication technologies themselves. Indeed, building flexible technologies that are tailored to the motor and visual skills of individuals with disabilities is well within the capabilities of modern devices and is an active area of research in Human-Computer Interaction and accessible computing.

This project will test artificial intelligence algorithms that are capable of interpreting idiosyncratic, individual-specific unaided gestures for augmentative and alternative communication access. This proposed system is intended to be human-centered, use-inspired, and readily-programmed, to empower both the user and their communication partners who may be involved in augmentative and alternative communication services. The project will solicit individuals with a wide range of motor disabilities to ensure the algorithms are widely applicable.

Being tested
Testing artificial intelligence algorithms for interpreting gestures
Medical subject headings
Cerebral Palsy, Blindness, Cortical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testing artificial intelligence algorithms for interpreting gesturesDevice

    The effectiveness of artificial intelligence algorithms for detecting and interpreting body-based gestures by individuals who have motor/visual impairments will be evaluated.

Study groups in NCT06599996
Study groupRoleWhat they receive
Evaluation of learnability and utility of artificial intelligence algorithmExperimentalParticipants will be learning to use the artificial intelligence algorithms and testing them for ease of use and efficiency
Receives: Device: Testing artificial intelligence algorithms for interpreting gestures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time taken for Programming of artificial intelligence algorithms by users/personal care aides

    How long it takes participants learn to program the algorithms (number of minutes taken)

    Measured: average of 12 months

  2. Number of messages programmed by users/personal care aides

    How many messages the user/personal care aide can program in the session

    Measured: average of 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start24 Sep 2024
  3. Primary completion1 May 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06599996
Sponsor's protocol ID
STUDY00024786
Acronym
AIinAAC
Status last verified
May 2025
First submitted
29 Aug 2024
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The "Databrary" repository will be used specifically because it (a) was developed for video sharing in particular, and (b) it allows for differential level of access, and only to members, all of which requires approval from the Study Investigator. The study Investigator will set up an access level where only the deidentified information about movement and algorithm function are available (for instance, the x-y-z coordinates that came from the sensor). The study Investigator will also set up a more restricted access level where an investigator who would like to see the original video of the movement could apply to obtain that level of access. The consent form notes that this type of sharing will occur.

Publications

  • Brady NC, Bruce S, Goldman A, Erickson K, Mineo B, Ogletree BT, Paul D, Romski MA, Sevcik R, Siegel E, Schoonover J, Snell M, Sylvester L, Wilkinson K. Communication Services and Supports for Individuals With Severe Disabilities: Guidance for Assessment and Intervention. Am J Intellect Dev Disabil. 2016 Mar;121(2):121-38. doi: 10.1352/1944-7558-121.2.121.

    PubMed 26914467
  • Koch Fager S, Fried-Oken M, Jakobs T, Beukelman DR. New and emerging access technologies for adults with complex communication needs and severe motor impairments: State of the science. Augment Altern Commun. 2019 Mar;35(1):13-25. doi: 10.1080/07434618.2018.1556730. Epub 2019 Jan 21.

    PubMed 30663899
  • Sennott SC, Akagi L, Lee M, Rhodes A. AAC and Artificial Intelligence (AI). Top Lang Disord. 2019 Oct-Dec;39(4):389-403. doi: 10.1097/tld.0000000000000197.

    PubMed 34012187
  • Sowers DJ, Wilkinson KM. Demands Associated With an Augmentative and Alternative Communication System in Relation to Alternative Forms of Access for Individuals With Motor Impairments. Am J Speech Lang Pathol. 2023 Jan 11;32(1):37-54. doi: 10.1044/2022_AJSLP-22-00006. Epub 2023 Jan 4.

    PubMed 36599109
  • Wilkinson KM, Elko LR, Elko E, McCarty TV, Sowers DJ, Blackstone S, Roman-Lantzy C. An Evidence-Based Approach to Augmentative and Alternative Communication Design for Individuals With Cortical Visual Impairment. Am J Speech Lang Pathol. 2023 Sep 11;32(5):1939-1960. doi: 10.1044/2023_AJSLP-22-00397. Epub 2023 Aug 18.

    PubMed 37594735

Questions about this trial

What is this clinical trial studying?

A study testing Testing artificial intelligence algorithms for interpreting gestures in people with Cerebral Palsy and Cortical Visual Impairment, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time taken for Programming of artificial intelligence algorithms by users/personal care aides (time frame: average of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06599996, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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