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Aphasia Rehabilitation: Modulating Cues, Feedback & Practice

Primary Purpose

Aphasia, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Script training
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Speech Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

High complexity, high feedback

High complexity, low feedback

Low complexity, high feedback

Low complexity, low feedback

Arm Description

Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance.

Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance.

Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance.

Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance.

Outcomes

Primary Outcome Measures

Percent accurate script related words
For trained script, untrained script, generalization script

Secondary Outcome Measures

Rate of script-related words
For trained script, untrained script, generalization script

Full Information

First Posted
May 9, 2012
Last Updated
November 28, 2018
Sponsor
Shirley Ryan AbilityLab
Collaborators
University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT01597037
Brief Title
Aphasia Rehabilitation: Modulating Cues, Feedback & Practice
Official Title
Aphasia Rehabilitation: Modulating Cues, Feedback & Practice
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
University of Colorado, Boulder

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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. The first part of the study - a cross-over study that evaluates error-free versus error-reducing script training has been done. Below is a description of the second part of the study which evaluates feedback and script complexity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
Aphasia, Speech Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High complexity, high feedback
Arm Type
Active Comparator
Arm Description
Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance.
Arm Title
High complexity, low feedback
Arm Type
Active Comparator
Arm Description
Scripts are one grade level higher than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance.
Arm Title
Low complexity, high feedback
Arm Type
Active Comparator
Arm Description
Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is an opportunity for the participant to listen to his/her production and assess performance.
Arm Title
Low complexity, low feedback
Arm Type
Active Comparator
Arm Description
Scripts are one grade level lower than the typical script that would be provided for the severity of aphasia; there is no opportunity for the participant to listen to his/her production and assess performance.
Intervention Type
Behavioral
Intervention Name(s)
Script training
Intervention Description
90 minutes/day, 6 days a week; includes 3 weeks of training
Primary Outcome Measure Information:
Title
Percent accurate script related words
Description
For trained script, untrained script, generalization script
Time Frame
Change from baseline to post-treatment in three weeks
Secondary Outcome Measure Information:
Title
Rate of script-related words
Description
For trained script, untrained script, generalization script
Time Frame
Change from baseline to post-treatment in three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35304120
Citation
Cherney LR, Van Vuuren S. Complexity and Feedback During Script Training in Aphasia: A Feasibility Study. Arch Phys Med Rehabil. 2022 Jul;103(7S):S205-S214. doi: 10.1016/j.apmr.2022.03.002. Epub 2022 Mar 15.
Results Reference
derived

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Aphasia Rehabilitation: Modulating Cues, Feedback & Practice

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