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An Investigation of Constraint Induced Language Therapy for Aphasia

Primary Purpose

Aphasia, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Constraint Induced Language Therapy
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia rehabilitation, Aphasia therapy, Constraint therapy, Language therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical Center (152)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
December 31, 2008
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00223847
Brief Title
An Investigation of Constraint Induced Language Therapy for Aphasia
Official Title
An Investigation of Constraint Induced Language Therapy for Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
Aphasia rehabilitation, Aphasia therapy, Constraint therapy, Language therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Constraint Induced Language Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Maher, PhD CCC/SLP
Organizational Affiliation
Michael E. DeBakey VA Medical Center (152)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center (152)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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An Investigation of Constraint Induced Language Therapy for Aphasia

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