The Intensive Comprehensive Aphasia Program (ICAP)

NCT03514186 | Completed

• 1 other identifier: 81035
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke

Keywords

Aphasia; Speech and Language Treatment; ICAP; Intensive Comprehensive Aphasia Program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)

  Change from pre-treatment to 3 month follow-up

• Assessment for Living with Aphasia (ALA)

  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)

  Change from pre-treatment to 3 month follow-up

• The Communication Confidence Rating Scale for Aphasia (CCRSA)

  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)

  Change from pre-treatment to 3 month follow-up

Study Arms (2)

Intensive Comprehensive Aphasia Program

EXPERIMENTAL

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

Distributed Comprehensive Aphasia Tx

ACTIVE COMPARATOR

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

Interventions

Speech and Language Therapy BEHAVIORAL

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

Distributed Comprehensive Aphasia Tx; Intensive Comprehensive Aphasia Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• months post injury
• premorbidly fluent in English
• receiving no concomitant speech-language therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Northwestern University: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke; Speech

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Leora Cherney, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Chair, Think & Speak Lab

Model Details: 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).

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 2, 2018
• Study Start: July 15, 2015
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)