An Investigation of Constraint Induced Language Therapy for Aphasia

December 31, 2008 updated by: US Department of Veterans Affairs
The purpose of this study is to investigate the effects of intensive, constraint induced language therapy (CILT) for individuals with chronic aphasia compared with traditional aphasia therapy. The specific objectives of the proposed research are to determine the effects of therapy type (CILT vs. traditional) and dose density (intensive or distributed) on speech therapy outcome. In addition, we will investigate the functional and qualitative impact of these interventions on functional communication.

Study Overview

Status

Completed

Conditions

Detailed Description

Objectives: Aphasia is an acquired language disorder that is a common sequelae of stroke and poses tremendous levels of handicap for the victim as well as burden for caregivers. While the efficacy of aphasia rehabilitation has been found to be statistically significant in its effect (Wertz et al., 1986; Robey, 1994), its clinical significance has been often disappointing (Siegel, 1987). A promising avenue for rehabilitation of chronic aphasia based on the approach and principles of Constraint Induced Movement Therapy (CIMT) has recently been described (Pulvermuller et al., 2001). These investigators reported that individuals with chronic, stable aphasia benefited (statistically as well as clinically) from language therapy designed to include attributes of CIMT (forced-use delivered in high doses over a relatively short period of time). In a limitation of the study, the conditions of constraint-induced language treatment (CILT) and traditional treatment were confounded by differences in treatment intensity. A pilot study funded by the VA Rehabilitation Research & Development (RR&D) to begin to control for confounding variables and treatment intensity is currently underway in a collaboration between the Houston VAMC Center of Excellence in Healthy Aging with Disabilities and the Brain Rehabilitation Research Center of Excellence in Gainesville, FL. While data collection is ongoing, preliminary results suggest that individuals with chronic aphasia made substantial, measurable change on a language battery following intensive CILT.

The purpose of this study is to expand on the pilot work we have done and to identify the functional and qualitative impact of these interventions on communication in naturalistic settings and on caregivers. Specifically, we will compare the relative impact of therapy type (constrained, forced speech TX vs. multi-modal PACE TX) and dose intensity (massed practice or distributed) on rehabilitation of chronic aphasia.

Research Plan: Using between group comparisons and multiple-baseline single subject comparisons, we will examine the impact of CILT in a larger group of individuals with aphasia, controlling for the confounding variables of massed practice, forced use and relevant context. In addition, we will investigate the functional and qualitative impact of these interventions on communication in naturalistic settings.

Methods: A total of 48 subjects collected at three sites (Houston, Gainesville and Tampa VAMCs) will be randomly assigned across four experimental conditions: 1) intensive CILT; 2) intensive PACE therapy; 3) distributed CILT and 4) distributed PACE therapy. Pre and post treatment language assessments, discourse samples, daily probe measures and qualitative interviews will be used to measure TX effects. In addition, these measures will be recollected one month following TX to assess the stability of the TX effects.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center (152)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Moderate to moderately severe, non-fluent aphasia Unilateral Left CVA Right-handed Primary Language is English Adequate hearing and vision to participate in group therapy

Exclusion Criteria:

Multiple strokes HX of other neurological impairment (e.g. dementia) Non-English speaking Poor auditory comprehension Severe apraxia of speech

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lynn Maher, PhD CCC/SLP, Michael E. DeBakey VA Medical Center (152)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 1, 2009

Last Update Submitted That Met QC Criteria

December 31, 2008

Last Verified

December 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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