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Treatment for Reading and Writing Deficits Following Acquired Brain Injury

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ClinicalTrials.gov Identifier: NCT03662243
Recruitment Status : Enrolling by invitation
First Posted : September 7, 2018
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Karen Hux, Quality Living, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Acquired Brain Injury Alexia Agraphia Behavioral: Multicomponent reading and writing treatment

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Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment for Reading and Writing Deficits Following Acquired Brain Injury
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

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.
Behavioral: Multicomponent reading and writing treatment
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.




Primary Outcome Measures :
  1. Change in score on Word Attack subtest of the Woodcock-Johnson III Test of Achievement. [ Time Frame: Change from baseline at 8 weeks ]
    Subtest raw sores range from 0 to 32,with higher scores indicating better performance.

  2. Change in score on Passage Comprehension subtest of the Woodcock-Johnson III Test of Achievement. [ Time Frame: Change from baseline at 8 weeks ]
    Subtest raw scores range from 0 to 47, with higher scores indicating better performance.

  3. Change in score on Word Reading subtest of the Wide Range Achievement Test 4. [ Time Frame: Change from baseline at 8 weeks ]
    Subtest raw scores range from 0 to 70, with higher scores indicating better performance.

  4. Change in score on Spelling subtest of the Wide Range Achievement Test 4. [ Time Frame: Change from baseline at 8 weeks ]
    Subtest raw scores range from 0 to 57, with higher scores indicating better performance.

  5. Change in score on Test of Silent Reading Speed and Efficiency. [ Time Frame: Change from baseline at 8 weeks ]
    Raw scores range from 0 to 70, with higher scores indicating better performance.


Secondary Outcome Measures :
  1. Sight word decoding accuracy [ Time Frame: One time per week for 8 weeks ]
    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.

  2. Oral reading rate of passages [ Time Frame: As the first of five tasks of each session for 8 weeks (each session is 1 hour). ]
    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.

  3. 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). ]
    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.

  4. Oral spelling of words [ Time Frame: As the second of five tasks of each session for 8 weeks (each session is 1 hour). ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662243


Locations
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United States, Nebraska
Quality Living, Inc.
Omaha, Nebraska, United States, 68104
Sponsors and Collaborators
Quality Living, Inc.
Investigators
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Principal Investigator: Karen Hux, Ph.D. Quality Living, Inc., Omaha, Nebraska

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Responsible Party: Karen Hux, Director of Research, Quality Living, Inc.
ClinicalTrials.gov Identifier: NCT03662243     History of Changes
Other Study ID Numbers: Reading/writing treatment
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Agraphia
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms