Modulating Intensity and Dosage of Aphasia Scripts

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2024-12-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate how changing conditions of speech-language treatment (namely, amount of repetition and distribution of practice schedule) affects the language outcome of participants with aphasia following a stroke. Using a computer based speech and language therapy program, participants will practice conversational scripts that are either short or long. Participants will practice for either 2 weeks (5 days a week) or for 5 weeks (2 days a week).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurobiology of Language Recovery in Aphasia: Natural History and Treatment-Induced Recovery

NCT01927302

Aphasia Dysgraphia Anomia +2 more

COMPLETED NA

Web-Based Treatment for Aphasia

NCT04413136

Aphasia

COMPLETED NA

Treatment Intensity - Apraxia of Speech

NCT02332915

Aphasia CVA Apraxia of Speech

COMPLETED NA

A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes

NCT01979159

Apraxia of Speech Aphasia

COMPLETED NA

Speech Entrainment Treatment for People With Aphasia

NCT05687994

Aphasia, Acquired

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Determining the optimal intensity of treatment is essential to the design and implementation of any treatment program for aphasia. Yet, treatment intensity is a complex construct and information on the variables modulating it remain ambiguous and limited. Studies reported in the neuroscience and clinical literature support the need for intensive treatment to induce long-term neuroplastic changes while the cognitive psychology literature suggests that learning is best maintained with distributed schedules. A few studies have looked at dose parameters for single word naming tasks, but there is limited evidence regarding dose parameters for treatments that focus on training the production of larger units, such as sentences or even connected discourse. One approach that is frequently used clinically and has evidence for its efficacy is script training. Little is currently known regarding the optimum dose of script training (i.e., the number of repetitions over time of each sentence within the script) that is required to promote the best outcomes.

This study investigates the effects of modulating stimulus variables, specifically stimulus practice distribution and stimulus repetition. We use a baseline script treatment that has experimental support regarding its efficacy, and that allows the manipulation of these variables. To ensure independence and fidelity, treatment is provided in a controlled computer environment (desktop and tablet). To avoid clinician-related variables such as expertise and personality factors that may influence treatment, sentences are modeled during treatment by an anthropomorphic agent with high visual speech intelligibility and affective expressions.

With regard to "best outcomes", generalization is the ultimate goal of any treatment approach. Therefore, the primary outcome is a generalization measure of conversation. Secondary measures address short-term acquisition, longer-term maintenance, and stimulus and response generalization for assessing gain over baseline, differential effects, and interactions. A mobile-connected wireless wearable laryngeal sensor allows tracking of talk time at home and in the community as a measure of treatment effectiveness and transfer. For privacy, it does not record audio.

Results and computational models of learning (generalization, short-term acquisition, and longer-term maintenance) will contribute new evidence to fill critical gaps in current scientific understanding regarding the effectiveness and clinical application of aphasia treatment approaches. More generally, findings will help to inform clinical practice and treatment of neurologic communication disorders; the virtual clinician guided intervention that the proposal develops has the potential to reduce costly clinician-client time otherwise required for long-term rehabilitation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aphasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Single (Outcomes Assessor)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Distributed, Short Script

Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.

Group Type EXPERIMENTAL