- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05520528
Impact of Group Participation on Adults With Aphasia
Study Overview
Status
Detailed Description
The objective of this research is to determine if attendance in groups positively impacts language skills, activity/participation, and/or quality of life in persons with aphasia.
This study will employ a university-clinic based outpatient group to administer language intervention. The specific aims of this study are to determine if group participation improves (1) life participation as measured by self-report questionnaires, (2) intervention-specific language skills as measured by treatment-related measures (e.g., reading comprehension and written expression), and (3) performance on non-treated language test scores as measured by a language assessment battery.
Participants will complete 4-5 individual testing sessions (e.g., initial assessment and pre-/post-testing), 7-12 group sessions (90-minute weekly reading group session), and 7-12 independent sessions at home (e.g., completion of weekly reading assignments).
The participants will read through a designated book incrementally across multiple weeks. The activities completed during the group sessions will focus on improving reading comprehension and written expression skills. Participants will read assigned passages at home and during the group sessions. Participants will complete a Copy and Recall Treatment (CART) worksheet independently to facilitate improvements in writing keywords related to the reading materials. CART involves copying target words and progresses to writing words from recall (Beeson, et al.). Participants will complete a reading comprehension worksheet and engage in discussion regarding the assigned book chapter.
Reading comprehension and written expression data will be collected and analyzed to compare the pre-treatment baseline performance from the first treatment session to the post-treatment performance from the last treatment session. Pre-and post-testing scores will be analyzed to investigate the change in scores across the 2-time points to determine the relative effectiveness of book club participation for improving reading comprehension, written expression, and life participation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72204
- UAM CHP Speech-Language and Hearing Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- Pre-morbid proficient speaker of English
- Diagnosis of adult-onset aphasia
- Vision and hearing sufficient to complete assessments
Exclusion Criteria:
- No history of childhood speech or language difficulties
- No history of major psychiatric illness, cognitive impairment, or neurological disorders such as seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reading Group
All participants in this group will receive language intervention within weekly group sessions and independent tasks with emphasis on improving reading and writing skills among persons with aphasia.
|
The participants will read through a designated book incrementally across multiple weeks at home and complete reading, writing, and discussion related to weekly readings in a group setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading Comprehension Battery for Aphasia-2 (RCBA-2; LaPointe & Horner, 1998) Scores
Time Frame: 1-week after intervention
|
To determine if group participation improves intervention-specific language skills in reading comprehension by comparing baseline score to 1-week post-intervention score
|
1-week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Communication Confidence Rating Scale for Aphasia (CCRSA; Babbitt & Cherney, 2010)
Time Frame: 1-week post-intervention
|
To determine participant's feelings related to their communication.
Participants rate their confidence on a scale from 0 to 100 for different communication-related activities.
Baseline score will be compared to 1-week post-intervention score
|
1-week post-intervention
|
|
Discourse Production Task
Time Frame: 1-week post-intervention
|
Discourse analysis of participants producing monologic narratives (e.g., story retell, procedural explanation, picture sequence description, etc.).
Baseline score will be compared to 1-week post-intervention score
|
1-week post-intervention
|
|
Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 1-week post-intervention
|
Selected PROMIS instruments (from cognitive, emotional, and social domains) will be used to measure satisfaction with and quality of life.
Baseline score will be compared to 1-week post-intervention score.
|
1-week post-intervention
|
|
Gray Oral Reading Test (GORT; Wiederholt & Bryant, 2012)
Time Frame: 1-week post-intervention
|
To determine changes in oral reading and reading comprehension, baseline score will be compared to 1-week post-intervention score
|
1-week post-intervention
|
|
Writing of Untrained Control Words (non-standardized).
Time Frame: 1-week post-intervention
|
Writing untrained words that will be matched for frequency, length, and complexity with the CART trained words to measure generalization.
Baseline score will be compared to 1-week post-intervention score
|
1-week post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dana Moser, Ph.D, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 274500
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
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 Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly