An Investigation of Constraint Induced Language Therapy for Aphasia

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00223847
First received: September 14, 2005
Last updated: December 31, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Aphasia
Stroke
Behavioral: Constraint Induced Language Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigation of Constraint Induced Language Therapy for Aphasia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Enrollment: 48
Study Start Date: August 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Behavioral: Constraint Induced Language Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223847

Locations
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Lynn Maher, PhD CCC/SLP Michael E. DeBakey VA Medical Center (152)
  More Information

No publications provided

Responsible Party: Maher, Lynn - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223847     History of Changes
Other Study ID Numbers: C3091R
Study First Received: September 14, 2005
Last Updated: December 31, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aphasia rehabilitation
Aphasia therapy
Constraint therapy
Language therapy

Additional relevant MeSH terms:
Aphasia
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders

ClinicalTrials.gov processed this record on October 22, 2014