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.
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
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.
- Conditions
- Cerebral Palsy, Cortical Visual Impairment
- 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 group | Role | What they receive |
|---|---|---|
| Evaluation of learnability and utility of artificial intelligence algorithm | Experimental | Participants 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.
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
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.
- First posted19 Sep 2024
- Study start24 Sep 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Wilkinson, Penn State University
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 26914467Koch 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 30663899Sennott 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 34012187Sowers 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 36599109Wilkinson 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Artificial Intelligence to Improve Access to Augmentative and Alternative Communication
- ClinicalTrials.gov ID
- NCT06599996
- Acronym / sponsor ID
- AIinAAC / STUDY00024786
- Conditions
- Cerebral Palsy, Cortical Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of learnability and utility of artificial intelligence algorithm | Experimental | Device: Testing artificial intelligence algorithms for interpreting gesturesParticipants will be learning to use the artificial intelligence algorithms and testing them for ease of use and efficiency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing artificial intelligence algorithms for interpreting gesturesThe effectiveness of artificial intelligence algorithms for detecting and interpreting body-based gestures by individuals who have motor/visual impairments will be evaluated. | Device | Evaluation of learnability and utility of artificial intelligence algorithm |
Primary outcome
Time taken for Programming of artificial intelligence algorithms by users/personal care aides
Time frame: average of 12 months
How long it takes participants learn to program the algorithms (number of minutes taken)
Number of messages programmed by users/personal care aides
Time frame: average of 12 months
How many messages the user/personal care aide can program in the session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 26914467Brady 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.
- Background: PubMed 30663899Koch 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.
- Background: PubMed 34012187Sennott 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.
- Background: PubMed 36599109Sowers 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.
- Background: PubMed 37594735Wilkinson 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.