Aphasia Rehabilitation: Modulating Cues, Feedback & Practice

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Rehabilitation Institute of Chicago
Sponsor:
Collaborator:
University of Colorado, Boulder
Information provided by (Responsible Party):
Leora Cherney, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01597037
First received: May 9, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate how changing different conditions of the speech-language treatment (such as cues, feedback, complexity and practice schedule) affects the language outcome of study subjects with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language) following a stroke.


Condition Intervention Phase
Aphasia
Stroke
Behavioral: Script training
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aphasia Rehabilitation: Modulating Cues, Feedback & Practice

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Percent accurate script related words [ Time Frame: Change from baseline to post-treatment in three weeks ] [ Designated as safety issue: No ]
    For trained script, untrained script, generalization script


Secondary Outcome Measures:
  • Rate of script-related words [ Time Frame: Change from baseline to post-treatment in three weeks ] [ Designated as safety issue: No ]
    For trained script, untrained script, generalization script


Estimated Enrollment: 8
Study Start Date: June 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Script training
    90 minutes/day, 6 days a week; includes 3 weeks of training in an errorful condition and 3 weeks of training in an error-reducing condition
Detailed Description:

Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year.

A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating. Recently, there has been an emphasis on the need for intensive aphasia treatment in order to make the long-term neuroplastic changes associated with recovery. However, specific information regarding effective learning parameters is limited.

A number of variables and practice conditions, deriving from motor learning theory, potentially impact the rehabilitation process. Several of these variables have begun to be addressed in the literature, but with conflicting or scant evidence to date. Variables include the type and degree of external cueing, low versus high feedback conditions, task complexity, and practice distribution and schedule.

The purpose of this study is to:

  • Modulate variables of cuing, feedback and script complexity that potentially affect treatment outcomes, and measure their effects on acquisition, maintenance and generalization of script learning. These investigations are conducted as separate studies, with the first study being a cross-over study investigating cuing and the second study being a 2x2 factorial design investigating feedback and complexity.
  • Modify and optimize AphasiaScripts—an existing treatment program having experimental support for its efficacy—by incorporating these findings.
  • Conduct a clinical trial, incorporating the optimized AphasiaScripts program, in order to measure the effect of massed vs distributed practice, and blocked vs random practice schedules, on the acquisition, maintenance and generalization of script learning.

Measures will include independent pre-and post assessments of acquisition, maintenance and generalization of script learning as well as dependent item/cue level measures of progress.

Results and computational models of acquisition, maintenance and generalization will contribute new evidence to support not just the efficacy and delivery of AphasiaScripts, but also the application of practice principles to aphasia treatment in general.

Below is the description for the first part of the study only - a cross-over study that evaluates error-free versus error-reducing script training.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A single unilateral left-hemisphere stroke
  • Aphasia Quotient between 40 and 80 on the Western Aphasia Battery
  • Age 21 or older
  • At least 6 months post-stroke
  • Able to comply with the study protocol
  • Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
  • Fluent in English premorbidly
  • Completed at least 8th grade education

Exclusion Criteria:

  • More than one stroke
  • Any other neurological condition that could potentially affect cognition, speech or language.
  • Global aphasia or inability to participate in routine speech therapy
  • Major active psychiatric illness that may interfere with required study procedures
  • Untreated or inadequately treated depression
  • Current abuse of alcohol or drugs
  • Unable to understand, cooperate or comply with study procedures
  • Significant visual or auditory impairment
  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: NCT01597037

Contacts
Contact: Leora R Cherney, Ph.D. 312 238-1117 lcherney@ric.org
Contact: Rosalind C Kaye, Ph.D. 312 238-6163 rkaye@ric.org

Locations
United States, Illinois
Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Roz Kaye, PhD    312-238-6163    rkaye@ric.org   
Sponsors and Collaborators
Rehabilitation Institute of Chicago
University of Colorado, Boulder
  More Information

No publications provided

Responsible Party: Leora Cherney, Senior Research Scientist, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01597037     History of Changes
Other Study ID Numbers: 1R01DC011754
Study First Received: May 9, 2012
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
Aphasia
Speech Rehabilitation

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 20, 2014