- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163461
Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia
Real Word Effects in Phonological Treatment for Word Retrieval
Study Overview
Detailed Description
The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy).
Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- left hemisphere stroke
- monolingual English speaking
- right handed
- presence of aphasia
Exclusion Criteria:
- preexisting neurological condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Treatment
individuals will receive 60 hours of speech therapy
|
individuals will receive 60 hours of behavioral speech therapy
|
|
Experimental: Delayed Treatment
individuals will receive 60 hours of speech therapy after 6 week delay period
|
individuals will receive 60 hours of behavioral speech therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech Production
Time Frame: Baseline to one week post treatment termination and three months post treatment termination
|
percent change in the number of untrained words spoken correctly
|
Baseline to one week post treatment termination and three months post treatment termination
|
Collaborators and Investigators
Investigators
- Principal Investigator: Diane L. Kendall, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C6572-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aphasia
-
Teachers College, Columbia UniversityRecruitingAphasia | Aphasia, Acquired | Aphasia, Broca | Aphasia Non Fluent | Aphasia, Anomic | Aphasia Following Cerebral Infarction | Aphasia, Mixed | Aphasia, Expressive | Aphasia, Conduction | Aphasia, RehabilitationUnited States
-
University of California, BerkeleyUniversity of California, San Francisco; National Institute on Deafness and... and other collaboratorsRecruitingAphasia | Aphasia, Acquired | Aphasia Following Cerebral Infarction | Aphasia, Non-fluent | Aphasia, Fluent | Aphasia Following Nontraumatic Intracerebral HemorrhageUnited States
-
University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Aphasia | Stroke, Ischemic | Aphasia, Broca | Aphasia, Anomic | Aphasia, Global | Aphasia, Fluent | Aphasia, Mixed | Aphasia, Jargon | Aphasia, Expressive | Aphasia, ConductionUnited States
-
Maya HenryNational Institute on Aging (NIA)RecruitingLogopenic Variant Primary Progressive Aphasia | Progressive Aphasia | Logopenic Progressive Aphasia (LPA) | Primary Progressive Aphasia(PPA) | Logopenic Variant of Primary Progressive Aphasia (LPA) | Progressive Aphasia in Alzheimer's DiseaseUnited States
-
Maya HenryNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingSemantic Dementia | Logopenic Progressive Aphasia | Nonfluent Aphasia, Progressive | Logopenic Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive Aphasia (svPPA) | Nonfluent Variant Primary Progressive Aphasia (nfvPPA) | Progressive Aphasia | Logopenic Progressive Aphasia... and other conditionsUnited States
-
University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
-
University of Texas at AustinNational Institute on Deafness and Other Communication Disorders (NIDCD)Enrolling by invitationPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
-
Institute for Bioengineering of CataloniaHospital Universitari Joan XXIII de Tarragona.; Universitat Pompeu FabraCompletedAphasia | Aphasia, Broca | Aphasia, Wernicke | Aphasia, Fluent | Aphasia, NonfluentSpain
-
Dr. Ram Manohar Lohia HospitalNot yet recruitingAphasia, Acquired | Aphasia Following Cerebral Infarction | Post Stroke Aphasia | Acute Ischemic Cerebrovascular DiseaseIndia
-
Flint Rehabilitation Devices, LLCUniversity of TexasCompleted
Clinical Trials on speech therapy
-
Assistance Publique Hopitaux De MarseilleRecruitingEpilepsy | Temporal Lobe Epilepsy | AnomiaFrance
-
National Taiwan University HospitalRecruitingAutism | Language Delay | Speech Disorders in ChildrenTaiwan
-
Hospital de Clinicas de Porto AlegreCompletedOral Cancer | Intelligibility, Speech | Tongue Cancer | Jaw CancerBrazil
-
Ewha Womans University Seoul HospitalEwha Womans University Mokdong Hospital; National Rehabilitation Center, Seoul...CompletedDysarthria As Late Effect of StrokeKorea, Republic of
-
Klinik ArlesheimUniversity of Bern; Paracelsus-Spital RichterswilCompletedHypertension
-
Johns Hopkins UniversityWithdrawn
-
Riphah International UniversityCompletedAutism Spectrum DisorderPakistan
-
Iran University of Medical SciencesCompletedParkinson Disease | Speech Disorders | Voice DisordersIran, Islamic Republic of
-
Ewha Womans University Seoul HospitalEwha Womans University Mokdong Hospital; National Rehabilitation Center, Seoul...Not yet recruitingDysarthria As Late Effect of Stroke
-
Medical University of WarsawCompleted