Back to resultsHome Program Practice for People With Language Disorders After Stroke
Primary Purpose
Aphasia, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Logbook
Sponsored by
About this trial
This is an interventional health services research trial for Aphasia
Eligibility Criteria
Inclusion Criteria:
- at least 6 months post left hemisphere stroke with a diagnosis of aphasia
- must have self-reported interest in working to improve reading comprehension
- access to the Internet
- speak English as a primary language
Exclusion Criteria:
- significant visual or hearing impairment as determined by "aphasia-friendly" and age-appropriate screening
- actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested
- severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).
Sites / Locations
- Duquesne University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single-Subject Design
Arm Description
Each participant will go through a baseline phase and then an intervention phase.
Outcomes
Primary Outcome Measures
Change in minutes of practice
The number of minutes practiced
Change in percentage of adherence to practice goal
The amount of practice compared to the goal
Secondary Outcome Measures
Reading comprehension
As measured by performance on the Reading Comprehension Battery for Aphasia-2 (RCBA-2). A higher score is better.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04543084
Brief Title
Home Program Practice for People With Language Disorders After Stroke
Official Title
Improving Home Program Practice for People With Language Disorders After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
September 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duquesne University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-subject Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Subject Design
Arm Type
Other
Arm Description
Each participant will go through a baseline phase and then an intervention phase.
Intervention Type
Behavioral
Intervention Name(s)
Logbook
Intervention Description
Participants will record practice in a logbook.
Primary Outcome Measure Information:
Title
Change in minutes of practice
Description
The number of minutes practiced
Time Frame
Up to 11 weeks
Title
Change in percentage of adherence to practice goal
Description
The amount of practice compared to the goal
Time Frame
Up to 11 weeks
Secondary Outcome Measure Information:
Title
Reading comprehension
Description
As measured by performance on the Reading Comprehension Battery for Aphasia-2 (RCBA-2). A higher score is better.
Time Frame
At first session and at last session time in between up to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 6 months post left hemisphere stroke with a diagnosis of aphasia
must have self-reported interest in working to improve reading comprehension
access to the Internet
speak English as a primary language
Exclusion Criteria:
significant visual or hearing impairment as determined by "aphasia-friendly" and age-appropriate screening
actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested
severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena V. Donoso Brown, PhD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duquesne University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15228
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home Program Practice for People With Language Disorders After Stroke
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