NCT06599996

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 24, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

August 29, 2024

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    average of 12 months

Study Arms (1)

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

Device: Testing artificial intelligence algorithms for interpreting gestures

Interventions

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

Evaluation of learnability and utility of artificial intelligence algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (5)

  • 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.

    PMID: 26914467BACKGROUND
  • 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.

    PMID: 30663899BACKGROUND
  • 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.

    PMID: 34012187BACKGROUND
  • 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.

    PMID: 36599109BACKGROUND
  • 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.

    PMID: 37594735BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyBlindness, Cortical

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBlindnessVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 19, 2024

Study Start

September 24, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations