AphasiaNCT00223847
An Investigation of Constraint Induced Language Therapy for Aphasia
A study testing Constraint Induced Language Therapy in people with Aphasia and Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of intensive, constraint induced language therapy (CILT) for individuals with chronic aphasia compared with traditional aphasia therapy. The specific objectives of the proposed research are to determine the effects of therapy type (CILT vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Constraint Induced Language Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2006
- 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
- Moderate to moderately severe, non-fluent aphasia Unilateral Left CVA Right-handed Primary Language is English Adequate hearing and vision to participate in group therapy
Who cannot join
- Multiple strokes HX of other neurological impairment (e.g. dementia) Non-English speaking Poor auditory comprehension Severe apraxia of speech
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
About this study
The purpose of this study is to investigate the effects of intensive, constraint induced language therapy (CILT) for individuals with chronic aphasia compared with traditional aphasia therapy. The specific objectives of the proposed research are to determine the effects of therapy type (CILT vs. traditional) and dose density (intensive or distributed) on speech therapy outcome. In addition, we will investigate the functional and qualitative impact of these interventions on functional communication.
Read the detailed description
Objectives: Aphasia is an acquired language disorder that is a common sequelae of stroke and poses tremendous levels of handicap for the victim as well as burden for caregivers. While the efficacy of aphasia rehabilitation has been found to be statistically significant in its effect (Wertz et al., 1986; Robey, 1994), its clinical significance has been often disappointing (Siegel, 1987). A promising avenue for rehabilitation of chronic aphasia based on the approach and principles of Constraint Induced Movement Therapy (CIMT) has recently been described (Pulvermuller et al., 2001). These investigators reported that individuals with chronic, stable aphasia benefited (statistically as well as clinically) from language therapy designed to include attributes of CIMT (forced-use delivered in high doses over a relatively short period of time). In a limitation of the study, the conditions of constraint-induced language treatment (CILT) and traditional treatment were confounded by differences in treatment intensity. A pilot study funded by the VA Rehabilitation Research \& Development (RR\&D) to begin to control for confounding variables and treatment intensity is currently underway in a collaboration between the Houston VAMC Center of Excellence in Healthy Aging with Disabilities and the Brain Rehabilitation Research Center of Excellence in Gainesville, FL. While data collection is ongoing, preliminary results suggest that individuals with chronic aphasia made substantial, measurable change on a language battery following intensive CILT.
The purpose of this study is to expand on the pilot work we have done and to identify the functional and qualitative impact of these interventions on communication in naturalistic settings and on caregivers. Specifically, we will compare the relative impact of therapy type (constrained, forced speech TX vs. multi-modal PACE TX) and dose intensity (massed practice or distributed) on rehabilitation of chronic aphasia.
Research Plan: Using between group comparisons and multiple-baseline single subject comparisons, we will examine the impact of CILT in a larger group of individuals with aphasia, controlling for the confounding variables of massed practice, forced use and relevant context. In addition, we will investigate the functional and qualitative impact of these interventions on communication in naturalistic settings.
Methods: A total of 48 subjects collected at three sites (Houston, Gainesville and Tampa VAMCs) will be randomly assigned across four experimental conditions: 1) intensive CILT; 2) intensive PACE therapy; 3) distributed CILT and 4) distributed PACE therapy. Pre and post treatment language assessments, discourse samples, daily probe measures and qualitative interviews will be used to measure TX effects. In addition, these measures will be recollected one month following TX to assess the stability of the TX effects.
- Being tested
- Constraint Induced Language Therapy
- Keywords
- Aphasia rehabilitation, Aphasia therapy, Constraint therapy, Language therapy
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced Language TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Behavioral: Constraint Induced Language Therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionJun 2006
- Study completionJun 2006
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
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Lynn Maher, PhD CCC/SLP, Principal investigator, Michael E. DeBakey VA Medical Center (152)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223847
- Sponsor's protocol ID
- C3091R
- Status last verified
- Dec 2008
- First submitted
- 14 Sep 2005
- Last updated
- 1 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Constraint Induced Language Therapy for Aphasia
- ClinicalTrials.gov ID
- NCT00223847
- Acronym / sponsor ID
- C3091R
- Keywords
- Aphasia rehabilitation, Aphasia therapy, Constraint therapy, Language therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- 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 investigate the effects of intensive, constraint induced language therapy (CILT) for individuals with chronic aphasia compared with traditional aphasia therapy. The specific objectives of the proposed research are to determine the effects of therapy type (CILT vs. traditional) and dose density (intensive or distributed) on speech therapy outcome. In addition, we will investigate the functional and qualitative impact of these interventions on functional communication.
Detailed description
Objectives: Aphasia is an acquired language disorder that is a common sequelae of stroke and poses tremendous levels of handicap for the victim as well as burden for caregivers. While the efficacy of aphasia rehabilitation has been found to be statistically significant in its effect (Wertz et al., 1986; Robey, 1994), its clinical significance has been often disappointing (Siegel, 1987). A promising avenue for rehabilitation of chronic aphasia based on the approach and principles of Constraint Induced Movement Therapy (CIMT) has recently been described (Pulvermuller et al., 2001). These investigators reported that individuals with chronic, stable aphasia benefited (statistically as well as clinically) from language therapy designed to include attributes of CIMT (forced-use delivered in high doses over a relatively short period of time). In a limitation of the study, the conditions of constraint-induced language treatment (CILT) and traditional treatment were confounded by differences in treatment intensity. A pilot study funded by the VA Rehabilitation Research \& Development (RR\&D) to begin to control for confounding variables and treatment intensity is currently underway in a collaboration between the Houston VAMC Center of Excellence in Healthy Aging with Disabilities and the Brain Rehabilitation Research Center of Excellence in Gainesville, FL. While data collection is ongoing, preliminary results suggest that individuals with chronic aphasia made substantial, measurable change on a language battery following intensive CILT.
The purpose of this study is to expand on the pilot work we have done and to identify the functional and qualitative impact of these interventions on communication in naturalistic settings and on caregivers. Specifically, we will compare the relative impact of therapy type (constrained, forced speech TX vs. multi-modal PACE TX) and dose intensity (massed practice or distributed) on rehabilitation of chronic aphasia.
Research Plan: Using between group comparisons and multiple-baseline single subject comparisons, we will examine the impact of CILT in a larger group of individuals with aphasia, controlling for the confounding variables of massed practice, forced use and relevant context. In addition, we will investigate the functional and qualitative impact of these interventions on communication in naturalistic settings.
Methods: A total of 48 subjects collected at three sites (Houston, Gainesville and Tampa VAMCs) will be randomly assigned across four experimental conditions: 1) intensive CILT; 2) intensive PACE therapy; 3) distributed CILT and 4) distributed PACE therapy. Pre and post treatment language assessments, discourse samples, daily probe measures and qualitative interviews will be used to measure TX effects. In addition, these measures will be recollected one month following TX to assess the stability of the TX effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Constraint Induced Language Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to moderately severe, non-fluent aphasia Unilateral Left CVA Right-handed Primary Language is English Adequate hearing and vision to participate in group therapy
Key exclusion criteria (1 listed)
- Multiple strokes HX of other neurological impairment (e.g. dementia) Non-English speaking Poor auditory comprehension Severe apraxia of speech
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 |
|---|---|---|
| Constraint Induced Language Therapy | Behavioural | 1 |
Primary outcome
Not reported in the source record.
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 1 Jan 2009.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Lynn Maher, PhD CCC/SLP principal investigator
Michael E. DeBakey VA Medical Center (152)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint Induced Language Therapy in people with Aphasia and Stroke, run by US Department of Veterans Affairs 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 1 inclusion and 1 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 1 Jan 2009. 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.
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 1 Jan 2009.