- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662243
Treatment for Reading and Writing Deficits Following Acquired Brain Injury
March 9, 2021 updated by: Karen Hux, Quality Living, Inc.
Many people with acquired brain injuries have deficits in reading decoding, reading comprehension, and written expression.
Alexia is a phenomenon in which a person who previously could read has trouble doing so after having sustained a brain injury; likewise, agraphia is an acquired writing problem affecting one or more aspects of written communication.
Alexia and agraphia sometimes co-occur with one another and/or with other language challenges, but they can also occur as isolated phenomena.
Methods to treat alexia and agraphia often focus on single intervention techniques that address aspects of reading or writing in isolation-such as matching written and spoken letters or letter sounds, performing choral reading, tracing letters, etc. Existing research suggests that the effectiveness of these techniques is limited.
However, when used in combination, such techniques may promote improved reading and written communication skills.
As such, the purpose of this research is to determine the extent to which a multicomponent intervention program improves the reading and writing capabilities of people with acquired alexia and/or agraphia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68104
- Quality Living, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
People enrolled in rehabilitation programs at Quality Living in Omaha, Nebraska, who are between the ages of 14 and 70 years and who experience alexia and/or agraphia secondary to acquired brain injury.
Description
Inclusion Criteria:
- Survivor of acquired brain injury
- Exhibits alexia and/or agraphia
- Past or current client of Quality Living, Inc., Omaha, Nebraska
- Fluent speaker of English
Exclusion Criteria:
- Vision impairment prohibiting reading of 24-point text
- Auditory comprehension problems precluding understanding of consent/assent information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acquired brain injury participants
People with acquired alexia and/or agraphia secondary to brain injury who participate in the reading/writing intervention.
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Intervention procedures incorporated into the program include drilling on sight words to improve immediate recognition of common words; engaging in Multiple Oral Reading procedures to increase reading fluency; practicing oral spelling of sight words to improve spelling accuracy; generating written sentences to improve accurate spelling and use of written conventions (e.g., punctuation, capitalization); and summarizing and subsequently writing sentences about read material to establish strategies to enhance reading comprehension and promote written expression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in score on Word Attack subtest of the Woodcock-Johnson III Test of Achievement.
Time Frame: Change from baseline at 8 weeks
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Subtest raw sores range from 0 to 32,with higher scores indicating better performance.
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Change from baseline at 8 weeks
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Change in score on Passage Comprehension subtest of the Woodcock-Johnson III Test of Achievement.
Time Frame: Change from baseline at 8 weeks
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Subtest raw scores range from 0 to 47, with higher scores indicating better performance.
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Change from baseline at 8 weeks
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Change in score on Word Reading subtest of the Wide Range Achievement Test 4.
Time Frame: Change from baseline at 8 weeks
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Subtest raw scores range from 0 to 70, with higher scores indicating better performance.
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Change from baseline at 8 weeks
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Change in score on Spelling subtest of the Wide Range Achievement Test 4.
Time Frame: Change from baseline at 8 weeks
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Subtest raw scores range from 0 to 57, with higher scores indicating better performance.
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Change from baseline at 8 weeks
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Change in score on Test of Silent Reading Speed and Efficiency.
Time Frame: Change from baseline at 8 weeks
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Raw scores range from 0 to 70, with higher scores indicating better performance.
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Change from baseline at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sight word decoding accuracy
Time Frame: One time per week for 8 weeks
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Percent of correct decoding on 315 words included in Dolch pre-primer, primer, kindergarten, first grade, second grade, third grade, and nouns lists.
Each word is scored as correct or incorrect, and a percent correct score is computed based on this scoring.
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One time per week for 8 weeks
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Oral reading rate of passages
Time Frame: As the first of five tasks of each session for 8 weeks (each session is 1 hour).
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Words per minute (wpm) during independent oral reading of passages.
The criteria for progression to subsequent passages is a reading rate of 80wpm or better.
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As the first of five tasks of each session for 8 weeks (each session is 1 hour).
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Decoding errors during oral reading of passages
Time Frame: As the first of five tasks of each session for 8 weeks (each session is 1 hour).
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Percent of uncorrected word decoding errors in a specified passage.
The criterion for progression to subsequent passages is fewer than 5% uncorrected words production errors.
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As the first of five tasks of each session for 8 weeks (each session is 1 hour).
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Oral spelling of words
Time Frame: As the second of five tasks of each session for 8 weeks (each session is 1 hour).
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Number of words spelled correctly on lists containing 15 words each.
Introduction of a new word list will occur only after a participant correctly spells all words on the current list.
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As the second of five tasks of each session for 8 weeks (each session is 1 hour).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karen Hux, Ph.D., Quality Living, Inc., Omaha, Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2018
Primary Completion (Actual)
September 15, 2020
Study Completion (Actual)
September 15, 2020
Study Registration Dates
First Submitted
September 3, 2018
First Submitted That Met QC Criteria
September 5, 2018
First Posted (Actual)
September 7, 2018
Study Record Updates
Last Update Posted (Actual)
March 10, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Reading/writing treatment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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