Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Intensive Comprehensive Aphasia Program (ICAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514186
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Leora Cherney, Shirley Ryan AbilityLab

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.

Condition or disease Intervention/treatment Phase
Aphasia Stroke Behavioral: Speech and Language Therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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.
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

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).
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514186


Locations
Layout table for location information
United States, Illinois
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Shirley Ryan AbilityLab
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: Leora Cherney, PhD Shirley Ryan AbilityLab

Layout table for additonal information
Responsible Party: Leora Cherney, Scientific Chair, Think & Speak Lab, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03514186     History of Changes
Other Study ID Numbers: 81035
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leora Cherney, Shirley Ryan AbilityLab:
Aphasia
Speech and Language Treatment
ICAP
Intensive Comprehensive Aphasia Program
Additional relevant MeSH terms:
Layout table for MeSH terms
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms