The Intensive Comprehensive Aphasia Program (ICAP)

Stroke Clinical Trial

Official title:

The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514186
• Other study ID #: 81035
• Status: Completed
• Phase: N/A
• Start date: July 15, 2015
• Est. completion date: June 2022

Study information

• Verified date: June 2022
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2022
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Behavioral:
• Speech and Language Therapy
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

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)	Includes a measure of auditory comprehension, oral expression, reading and writing	Change from pre-treatment to 3 month follow-up
Secondary	Assessment for Living with Aphasia (ALA)	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)
Secondary	Assessment for Living with Aphasia (ALA)	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
Secondary	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.	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	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.	Change from pre-treatment to 3 month follow-up
Secondary	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.	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	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.	Change from pre-treatment to 3 month follow-up