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The Intensive Comprehensive Aphasia Program (ICAP)

Primary Purpose

Aphasia, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech and Language Therapy
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 and Language Treatment, ICAP, Intensive Comprehensive Aphasia Program

Eligibility Criteria

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

Inclusion Criteria:

  1. diagnosis of an aphasia subsequent to a left-hemisphere infarct that is confirmed by CT scan or MRI
  2. an Aphasia Quotient score on the Western Aphasia Battery of 20-85.
  3. 6 months post injury
  4. premorbidly fluent in English
  5. receiving no concomitant speech-language therapy

Exclusion Criteria:

  1. diagnosis of Global aphasia
  2. any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's disease and other dementias, or traumatic brain injury
  3. any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization (subjects with mood disorders who are currently stable on treatment will be considered)
  4. active substance abuse.

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive Comprehensive Aphasia Program

Distributed Comprehensive Aphasia Tx

Arm Description

60 hours of comprehensive speech and language therapy applied intensively, 4 hours per day, 5 days a week for three weeks.

60 hours of comprehensive speech and language therapy distributed over 15 weeks (i.e. two 2-hour visits per week).

Outcomes

Primary Outcome Measures

Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
Includes a measure of auditory comprehension, oral expression, reading and written expression skills. Change from baseline to post-treatment and follow-up is reported.

Secondary Outcome Measures

Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
Includes a measure of auditory comprehension, oral expression, reading and writing
Assessment for Living with Aphasia (ALA)
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
Assessment for Living with Aphasia (ALA)
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
The Communication Confidence Rating Scale for Aphasia (CCRSA)
Self-reported measure that assesses perceived confidence in a variety of different communication situations and with different people. Scores range from 0 - 40, with higher scores indicating greater perceived confidence.
The Communication Confidence Rating Scale for Aphasia (CCRSA)
Self-reported measure that assesses perceived confidence in a variety of different communication situations and with different people. Scores range from 0 - 40, with higher scores indicating greater perceived confidence.
The Communicative Effectiveness Index (CETI)
A proxy-reported 16 visual analogue scale items that assess areas of functional communication in the participant's living environment. Scores range from 0 - 100, with higher scores indicating better communication effectiveness.
The Communicative Effectiveness Index (CETI)
A proxy-reported 16 visual analogue scale items that assess areas of functional communication in the participant's living environment. Scores range from 0 - 100, with higher scores indicating better communication effectiveness.

Full Information

First Posted
April 17, 2018
Last Updated
June 15, 2022
Sponsor
Shirley Ryan AbilityLab
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03514186
Brief Title
The Intensive Comprehensive Aphasia Program (ICAP)
Official Title
The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2015 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to conduct a randomized clinical trial that assesses the efficacy and cost-effectiveness of an Intensive Comprehensive Aphasia Program (ICAP), specifically focusing on the variable of intensity. Half of the participants will receive 60 hours of intensive treatment over three weeks, while the other half will receive the same amount and type of comprehensive treatment distributed over 15 weeks.
Detailed Description
Recent research has emphasized the need for intensive aphasia treatment in order to make the long-term neuroplastic changes associated with recovery and rehabilitation following a stroke. Furthermore, studies have indicated that intensive aphasia treatment is more efficacious than less intensive treatment. Rather than being influenced by such evidence, the reality is that public and private payers are drastically reducing services to persons with aphasia (PWA). Legislation has seriously curtailed the amount of treatment a PWA may receive after hospitalization. Often patients are eligible for only a limited number of treatment sessions over a limited period of time. In some cases, they may not receive any treatment for their communication disorder following their acute hospitalization. Reduced resources (e.g. transportation difficulties, therapist shortages in rural areas) also may severely limit available services. The Intensive Comprehensive Aphasia Program (ICAP) may be a creative, cost-effective and sustainable option for delivering meaningful and necessary aphasia services. Despite the growing numbers of ICAPs, there is little evidence about their efficacy, effectiveness, or cost-effectiveness. All stakeholders need this evidence. Funding agencies require evidence to make decisions about their investments in aphasia rehabilitation. People with aphasia and their families should have evidence prior to investing their money and time into such programs, and speech and language pathologists have an ethical obligation to provide evidence-based practices. Based on evidence regarding treatment intensity that has translated principles of neuroplasticity from animal models to stroke recovery, the investigators hypothesize that 60 hours of comprehensive treatment will result in significant improvements in (a) performance-based, (b) client-reported, and (c) surrogate-reported assessments of communication skills, community participation, and health-related quality of life. They also hypothesize that when 60 hours of comprehensive treatment is provided intensively over 3 weeks, the magnitude and rate of improvement as well as the extent to which improvements are maintained will be greater than when the 60 hours of comprehensive treatment is distributed over 15 weeks. Because the investigators hypothesize that the magnitude and rate of improvement will be greater with the intensive ICAP than with the distributed ICAP, they further hypothesize that the intensive ICAP will be more cost-effective than the distributed ICAP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
Aphasia, Speech and Language Treatment, ICAP, Intensive Comprehensive Aphasia Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both treatment arms will provide 60 hours of comprehensive aphasia therapy. In the ICAP arm, the 60 hours of treatment will be applied intensively, 4 hours per day, 5 days a week for three weeks. In the Distributed Treatment arm, the 60 hours of comprehensive treatment will be distributed over 15 weeks (i.e. two 2-hour visits per week).
Masking
Outcomes Assessor
Masking Description
Because of the nature of the intervention, neither the treating SLPs nor the subjects can be masked regarding the scheduling of treatment. To minimize outcome ascertainment bias, an evaluator (testing speech-language pathologist) who is not directly associated with the daily activities of the trial and, therefore, blind to the treatment arm will administer and score all the assessments. Subjects will be introduced to the treatment arm to which they have been assigned with a script that emphasizes similar expectations from the intervention, regardless of the treatment group. This will reduce subject bias resulting from such beliefs that one of the therapies is less effective.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Comprehensive Aphasia Program
Arm Type
Experimental
Arm Description
60 hours of comprehensive speech and language therapy applied intensively, 4 hours per day, 5 days a week for three weeks.
Arm Title
Distributed Comprehensive Aphasia Tx
Arm Type
Active Comparator
Arm Description
60 hours of comprehensive speech and language therapy distributed over 15 weeks (i.e. two 2-hour visits per week).
Intervention Type
Behavioral
Intervention Name(s)
Speech and Language Therapy
Intervention Description
Includes: one hour of individual therapy using a multimodality treatment called Verb Network Strengthening Treatment (VNeST) that simultaneously targets semantics (word retrieval) and syntax (sentence construction); one hour of constraint induced language therapy (CILT) where participants are paired and practice requesting and providing specific information using only spoken language; one hour in the computer lab working on programs called Oral Reading for Language in Aphasia (ORLA) and AphasiaScripts; and one hour in a conversation group that emphasizes multimodality communication
Primary Outcome Measure Information:
Title
Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
Description
Includes a measure of auditory comprehension, oral expression, reading and written expression skills. Change from baseline to post-treatment and follow-up is reported.
Time Frame
Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
Secondary Outcome Measure Information:
Title
Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
Description
Includes a measure of auditory comprehension, oral expression, reading and writing
Time Frame
Change from pre-treatment to 3 month follow-up
Title
Assessment for Living with Aphasia (ALA)
Description
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
Time Frame
Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
Title
Assessment for Living with Aphasia (ALA)
Description
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
Time Frame
Change from pre-treatment to 3 month follow-up
Title
The Communication Confidence Rating Scale for Aphasia (CCRSA)
Description
Self-reported measure that assesses perceived confidence in a variety of different communication situations and with different people. Scores range from 0 - 40, with higher scores indicating greater perceived confidence.
Time Frame
Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
Title
The Communication Confidence Rating Scale for Aphasia (CCRSA)
Description
Self-reported measure that assesses perceived confidence in a variety of different communication situations and with different people. Scores range from 0 - 40, with higher scores indicating greater perceived confidence.
Time Frame
Change from pre-treatment to 3 month follow-up
Title
The Communicative Effectiveness Index (CETI)
Description
A proxy-reported 16 visual analogue scale items that assess areas of functional communication in the participant's living environment. Scores range from 0 - 100, with higher scores indicating better communication effectiveness.
Time Frame
Change from pre-treatment to post-treatment (i.e. following completion of 60 hours of treatment at 3 weeks or 15 weeks depending on group assignment)
Title
The Communicative Effectiveness Index (CETI)
Description
A proxy-reported 16 visual analogue scale items that assess areas of functional communication in the participant's living environment. Scores range from 0 - 100, with higher scores indicating better communication effectiveness.
Time Frame
Change from pre-treatment to 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of an aphasia subsequent to a left-hemisphere infarct that is confirmed by CT scan or MRI an Aphasia Quotient score on the Western Aphasia Battery of 20-85. 6 months post injury premorbidly fluent in English receiving no concomitant speech-language therapy Exclusion Criteria: diagnosis of Global aphasia any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's disease and other dementias, or traumatic brain injury any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization (subjects with mood disorders who are currently stable on treatment will be considered) active substance abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leora Cherney, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Intensive Comprehensive Aphasia Program (ICAP)

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