Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia

NCT ID: NCT04081207

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-12-31

Brief Summary

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The currently available interventions only partially restore language abilities in patients with post-stroke aphasia; preventing successful reintegration into society. This study will increase our knowledge of how we can use assistive technology interventions to help people with aphasia restore language function. Further, this project will help us identify regions of the brain responsible for these changes.

Detailed Description

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In aphasia rehabilitation, usual care is focused on helping people recuperate as much of their pre-stroke language capacity as possible.Typically, usual care is a non-standardized therapy that is tailored to the specific needs of the person with aphasia.Once a person reaches a plateau in language recovery, AAC is implemented with a focus on circumventing, or compensating for the communication challenges associated with aphasia.

The ability of people with aphasia to (1) recover language function well-into the chronic phase of stroke recovery and (2) self-cue to promote word retrieval during anomic events offer the solution for how AAC could be employed as a dual-purpose tool to augment language recovery and compensate for deficits. This approach, however, this requires a shift in how AAC is implemented. With the goal of language recovery, treatment needs to focus on instructing people with aphasia how to use AAC as a mechanism for self-cueing, rather than as a tool to replace speaking. Based on our pilot data, we hypothesize that this novel method to AAC implementation will promote language recovery by coupling the canonical language and visual processing neural networks.

This work will also contribute to our ability to identify, a priori, who will respond to this particular AAC intervention and who will not, by combining neuroimaging with behavioral and clinical data. This has the potential to reduce the cost of healthcare for stroke recovery by implementing the most effective treatment possible. Importantly, when we identify non-responders, this will allow us to construct a profile and identify features of the AAC treatment that require adjustment to meet their unique needs.

Conditions

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Post-stroke Aphasia Aphasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participant cohorts: We will use a 2 (groups) X 4 (measurement time points) switching replications design\[18\] to examine the effects of AAC on aphasia severity and spoken language (AIM 1), elucidate the neurobiological mechanism of AAC-induced language recovery (AIM 2), and identify AAC treatment responder subgroups (Exploratory Aim). This design will allow Group 2 to serve as the control group; however, they will still receive AAC treatment; thus, allowing us to increase the total N who receives AAC treatment to 20 people.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AAC-LaRc

all participants receive the experimental treatment

Group Type EXPERIMENTAL

AAC for Language Recovery (AAC-LaRc)

Intervention Type BEHAVIORAL

iPads will be programmed with a personalized communication application (app) and a structured 4-step intervention will be employed to instruct patients how to cue themselves during anomic events via pictures, text, or speak buttons.

Interventions

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AAC for Language Recovery (AAC-LaRc)

iPads will be programmed with a personalized communication application (app) and a structured 4-step intervention will be employed to instruct patients how to cue themselves during anomic events via pictures, text, or speak buttons.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* at least 18 years old
* native speaker of american English
* compatible for 3 Tesla MRI
* Ischemic, left middle cerebral artery stroke
* at least 12 months post stroke
* pass hearing screening
* pass vision screening
* diagnosis of aphasia on the Western Aphasia Bedside Screen
* ability to produce 5-10 intelligible words
* no more than a moderate apraxia of speech or dysarthria
* minimal or no AAC/iPad experience
* written consent by self or guardian

Exclusion Criteria

* fails to meet the above
* Underlying degenerative or metabolic disorder or supervening medical illness
* Severe depression or other psychiatric disorder
* Report of pregnancy by women of childbearing age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Aimee Dietz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aimee Dietz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aimee Dietz, PhD

Role: CONTACT

513-558-8551

Jennifer Vannest, PhD

Role: CONTACT

513-558-8518

Facility Contacts

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Aimee Dietz, PhD

Role: primary

513-558-8551

Jennifer Vannest, BS

Role: backup

513-558-85418 ext. Dietz

References

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Dietz A, Vannest J, Maloney T, Altaye M, Holland S, Szaflarski JP. The feasibility of improving discourse in people with aphasia through AAC: Clinical and functional MRI correlates. Aphasiology. 2018;32(6):693-719. doi: 10.1080/02687038.2018.1447641. Epub 2018 Mar 9.

Reference Type BACKGROUND
PMID: 32999522 (View on PubMed)

Other Identifiers

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1R15DC017280-01

Identifier Type: NIH

Identifier Source: org_study_id

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