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The Intensive Comprehensive Aphasia Program (ICAP)

Shirley Ryan AbilityLab logo

Shirley Ryan AbilityLab

Status

Completed

Conditions

Stroke
Aphasia

Treatments

Behavioral: Speech and Language Therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

Intensive Comprehensive Aphasia Program
Experimental group
Description:
60 hours of comprehensive speech and language therapy applied intensively, 4 hours per day, 5 days a week for three weeks.
Treatment:
Behavioral: Speech and Language Therapy
Distributed Comprehensive Aphasia Tx
Active Comparator group
Description:
60 hours of comprehensive speech and language therapy distributed over 15 weeks (i.e. two 2-hour visits per week).
Treatment:
Behavioral: Speech and Language Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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