- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514186
The Intensive Comprehensive Aphasia Program (ICAP)
The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive Comprehensive Aphasia Program
60 hours of comprehensive speech and language therapy applied intensively, 4 hours per day, 5 days a week for three weeks.
|
Includes:
|
Active Comparator: Distributed Comprehensive Aphasia Tx
60 hours of comprehensive speech and language therapy distributed over 15 weeks (i.e. two 2-hour visits per week).
|
Includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
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)
|
Includes a measure of auditory comprehension, oral expression, reading and written expression skills.
Change from baseline to post-treatment and follow-up is reported.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
Time Frame: Change from pre-treatment to 3 month follow-up
|
Includes a measure of auditory comprehension, oral expression, reading and writing
|
Change from pre-treatment to 3 month follow-up
|
Assessment for Living with Aphasia (ALA)
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)
|
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
|
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)
|
Assessment for Living with Aphasia (ALA)
Time Frame: Change from pre-treatment to 3 month follow-up
|
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
|
Change from pre-treatment to 3 month follow-up
|
The Communication Confidence Rating Scale for Aphasia (CCRSA)
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)
|
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.
|
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)
|
The Communication Confidence Rating Scale for Aphasia (CCRSA)
Time Frame: Change from pre-treatment to 3 month follow-up
|
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.
|
Change from pre-treatment to 3 month follow-up
|
The Communicative Effectiveness Index (CETI)
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)
|
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.
|
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)
|
The Communicative Effectiveness Index (CETI)
Time Frame: Change from pre-treatment to 3 month follow-up
|
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.
|
Change from pre-treatment to 3 month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leora Cherney, PhD, Shirley Ryan AbilityLab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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