AphasiaNCT03514186
The Intensive Comprehensive Aphasia Program (ICAP)
A study testing Speech and Language Therapy in people with Aphasia and Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Speech and Language Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2015to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 6 months post injury
- premorbidly fluent in English
- receiving no concomitant speech-language therapy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Speech and Language Therapy
- Keywords
- Aphasia, Speech and Language Treatment, ICAP, Intensive Comprehensive Aphasia Program
- Medical subject headings
- Aphasia, Stroke, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech and Language TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Speech and Language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Includes a measure of auditory comprehension, oral expression, reading and writing
Measured: Change from pre-treatment to 3 month follow-up
Assessment for Living with Aphasia (ALA)
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
Measured: 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)
A pictographic self-report measure designed to assess outcomes associated with the impact of aphasia on daily life.
Measured: Change from pre-treatment to 3 month follow-up
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.
Measured: 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)
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.
Measured: Change from pre-treatment to 3 month follow-up
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.
Measured: 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 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.
Measured: Change from pre-treatment to 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start15 Jul 2015
- Primary completionMar 2019
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Leora Cherney, Shirley Ryan AbilityLab
- Investigators
- Leora Cherney, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514186
- Sponsor's protocol ID
- 81035
- Status last verified
- Jun 2022
- First submitted
- 17 Apr 2018
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intensive Comprehensive Aphasia Program (ICAP): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03514186
- Acronym / sponsor ID
- 81035
- Keywords
- Aphasia, Speech and Language Treatment, ICAP, Intensive Comprehensive Aphasia Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intensive Comprehensive Aphasia Program | Experimental | Behavioral: Speech and Language Therapy60 hours of comprehensive speech and language therapy applied intensively, 4 hours per day, 5 days a week for three weeks. |
| Distributed Comprehensive Aphasia Tx | Active comparator | Behavioral: Speech and Language Therapy60 hours of comprehensive speech and language therapy distributed over 15 weeks (i.e. two 2-hour visits per week). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 6 months post injury
- premorbidly fluent in English
- receiving no concomitant speech-language therapy
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech 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 | Behavioural | Distributed Comprehensive Aphasia Tx, Intensive Comprehensive Aphasia Program |
Primary outcome
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.
7 secondary outcomes
Language Quotient of the Western Aphasia Battery-Revised (WAB-R LQ)
Time frame: Change from pre-treatment to 3 month follow-up
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)
Assessment for Living with Aphasia (ALA)
Time frame: Change from pre-treatment to 3 month follow-up
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)
The Communication Confidence Rating Scale for Aphasia (CCRSA)
Time frame: Change from pre-treatment to 3 month follow-up
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)
The Communicative Effectiveness Index (CETI)
Time frame: Change from pre-treatment to 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leora Cherney, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech and Language Therapy in people with Aphasia and Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.