Adaptive AAC for Communication Disorders

Overseen By Joshua Kline, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Altec Inc.

Disqualifiers: Non-English speaker, Musculoskeletal conditions, Cardiac or respiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a communication device that adapts to each user’s physical abilities, enhancing communication for those with severe motor impairments. Participants will test both an experimental and a generic communication system (Adaptive AAC) to determine which is most effective for them. The trial targets individuals with conditions like cerebral palsy or spinal cord injuries who require alternative communication methods. Suitable participants should be able to spell, follow directions, and have some control over their head, hand, or foot. As an unphased trial, this study offers participants the chance to contribute to innovative solutions that could significantly improve communication for those with severe motor impairments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this AAC system is safe for communication disorders?

Studies have shown that augmentative and alternative communication (AAC) systems are generally safe for users. Research indicates that similar AAC methods have not widely reported negative effects, suggesting that the new AAC under study should be well-tolerated.

For the standard AAC, safety is also well-documented. A review of AAC tools for children with autism did not report significant safety concerns. Overall, both the new and standard AAC systems appear to have good safety records based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adaptive AAC for Communication Disorders trial because it explores innovative communication interfaces designed to enhance how individuals with communication disorders express themselves. Unlike traditional AAC (Augmentative and Alternative Communication) systems, which may use static symbols or text-based methods, the experimental AAC in this trial adapts to the user's needs in a dynamic way, potentially offering more personalized and efficient communication options. This adaptability could lead to improved user engagement and more effective communication, which is a significant step forward from the generic AAC systems currently in use.

What evidence suggests that this trial's AAC systems could be effective for communication disorders?

Studies have shown that Augmentative and Alternative Communication (AAC) systems can greatly assist people with speech difficulties. Research indicates that 89% of AAC users experienced improved communication abilities. One study found that one-third to half of children with limited speech benefitted from AAC use. For general AAC systems, research focuses on enhancing their effectiveness for individuals with severe speech and language issues. In this trial, participants will use both Experimental and Generic AAC systems. Both types offer promising ways to improve communication, particularly for individuals with conditions such as autism, Alzheimer's, or Parkinson's disease. ^{6 7 8 9 10}

Who Is on the Research Team?

Gianluca De Luca, M.S.

Principal Investigator

Altec Inc.

Are You a Good Fit for This Trial?

This trial is for individuals aged 6 or older with developmental communication disorders who can spell, follow instructions, and read large text. They must be able to attend multiple testing sessions and have voluntary muscle control in the head, hand, or foot without medical restrictions on movement.

Inclusion Criteria

I am 6 years old or older.

I can spell, follow instructions, and read large text.

I can control my head, hand, or foot well enough to use a special communication device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive both Experimental and Generic AAC systems to communicate, focusing on usability, improved performance, acceptance, and perceived benefit

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Experimental AAC
• Generic AAC

Trial Overview The study aims to develop a personalized Augmentative and Alternative Communication (AAC) system that adapts to the user's abilities. It will create a custom keyboard interface for those needing alternative methods of communication due to severe motor impairments.

How Is the Trial Designed?

Group I: Experimental and Generic Communication Interfaces for AAC Experimental Treatment 2 Interventions

Each participant receives both Experimental and Generic AAC systems to communicate - in that order.

Who Is Running the Clinical Trial?

Altec Inc.

Lead Sponsor

Trials

5

Recruited

110+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16671842/

The impact of augmentative and alternative communication ... None of the 27 cases demonstrated decreases in speech production as a result of AAC intervention, 11% showed no change, and the majority (89%) demonstrated ...

2. neuroregulation.org neuroregulation.org/article/view/23389

Clinical Effectiveness of AAC Intervention in Minimally ... One third to half of minimally verbal children could benefit from augmentative and alternative communication (AAC) intervention. In children and ...

3. asha.org asha.org/practice-portal/professional-issues/augmentative-and-alternative-communication/?srsltid=AfmBOooWISPq9HgQkzoMomcBb00GrgEiM22FL1NeOEzWiTJ2hMeTLcm8

Augmentative and Alternative Communication (AAC) The largest populations of individuals who could benefit from AAC had diagnoses of Alzheimer's/dementia (23%), Parkinson's disease (22%), autism spectrum ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9549491/

Speech-Language Pathologists' Practices in Augmentative ... This survey study examined augmentative and alternative communication (AAC) practices reported by early intervention speech-language pathologists (SLPs) ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/10400435.2023.2251041

A scoping review of communication outcomes measures in ... In the field of augmentative and alternative communication (AAC), the outcomes that researchers choose to measure often differs across studies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443945/

Communication Intervention to Teach Requesting Through ... This study examined the effectiveness of an intervention package to teach multiple, aided communication requests for two persons with Rett syndrome.

7. pubs.asha.org pubs.asha.org/doi/10.1044/2021_PERSP-20-00220

“Everyone Deserves AAC”: Preliminary Study of the ... Data analysis revealed three main categories from this theme: mental and physical states, modality features, and safety and trust. Mental and ...

8. communicationfirst.org communicationfirst.org/wp-content/uploads/2023/03/AAC-Counts-Report-Part-2-What-Existing-Data-Can-and-Cannot-Tell-Us.pdf

AAC Counts II: What Existing Data Can and Cannot Tell Us ... Augmentative and alternative communication, or AAC, is any tool, method, or support used by a person with a speech disability who cannot rely on speech alone to ...

9. withpower.com withpower.com/trial/phase-language-disorders-10-2024-646c3

AAC Generative Language Intervention for Speech Disorders There is no specific safety data available for AAC Generative Language Intervention, but studies on similar AAC interventions have not widely reported negative ...

10. cuh.nhs.uk cuh.nhs.uk/patient-information/online-safety-for-clients-accessing-augmentative-and-alternative-communication-aac/

Online safety for clients accessing augmentative and ... This leaflet is aimed at professionals working with people who use augmentative and assistive communication (AAC). It aims to outline some of the benefits and ...