Clinical Trials Directory

Trials / Completed

CompletedNCT03514186

The Intensive Comprehensive Aphasia Program (ICAP)

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Shirley Ryan AbilityLab · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSpeech and Language TherapyIncludes: * 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

Timeline

Start date
2015-07-15
Primary completion
2019-03-01
Completion
2022-06-01
First posted
2018-05-02
Last updated
2022-06-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03514186. Inclusion in this directory is not an endorsement.