Speech Therapy for Aphasia: Comparing Two Treatments

NCT ID: NCT02153710

Last Updated: 2019-09-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-11

Study Completion Date

2017-09-29

Brief Summary

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

This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called "aphasia." Individuals in this study will receive one of two treatments. The first is a phonological (sound level) treatment and the second is a semantic (word level) treatment. Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).

Detailed Description

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

Purpose: The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session as well as generalization to untrained exemplars and contexts. Phonomotor treatment (PMT) has shown such effects but has not yet been compared to a commonly used lexical/semantic based treatment (semantic feature analysis; SFA).

Methods: In a between group randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56-60 hours of intensively delivered treatment over 6 weeks with testing pre-, post- and three-months post treatment termination.

Conditions

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

Stroke

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

NONE

Study Groups

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

Phonomotor therapy

Experimental group

Group Type EXPERIMENTAL

Phonomotor Therapy

Intervention Type BEHAVIORAL

Experimental therapy.

Semantic Feature Analysis therapy

Current standard of care therapy

Group Type ACTIVE_COMPARATOR

Semantic Feature Analysis therapy

Intervention Type BEHAVIORAL

Control therapy; current standard of care therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Semantic Feature Analysis therapy

Control therapy; current standard of care therapy

Intervention Type BEHAVIORAL

Phonomotor Therapy

Experimental therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Single, left-hemisphere stroke
* English as primary language prior to stroke

Exclusion Criteria

* Other neurological disorders
* Untreated depression
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Portland State University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diane L. Kendall, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: University of Washington informed consent

View Document

Document Type: Informed Consent Form: VA informed consent

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

O1183-R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Speech Entrainment for Aphasia Recovery
NCT04364854 COMPLETED PHASE2
Clinic and Neurophysiology of Aphasia Treatment
NCT05572385 NOT_YET_RECRUITING NA
Criterion-learning Based Naming Treatment in Aphasia
NCT06364709 ENROLLING_BY_INVITATION NA
Augmenting Language Therapy for Aphasia: Levodopa
NCT01429077 COMPLETED PHASE2/PHASE3