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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03662243
Other study ID # Reading/writing treatment
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 30, 2018
Est. completion date September 15, 2020

Study information

Verified date March 2021
Source Quality Living, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date September 15, 2020
Est. primary completion date September 15, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years to 70 Years
Eligibility 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 Design


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.

Locations

Country Name City State
United States Quality Living, Inc. Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
Quality Living, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in score on Word Attack subtest of the Woodcock-Johnson III Test of Achievement. Subtest raw sores range from 0 to 32,with higher scores indicating better performance. Change from baseline at 8 weeks
Primary Change in score on Passage Comprehension subtest of the Woodcock-Johnson III Test of Achievement. Subtest raw scores range from 0 to 47, with higher scores indicating better performance. Change from baseline at 8 weeks
Primary Change in score on Word Reading subtest of the Wide Range Achievement Test 4. Subtest raw scores range from 0 to 70, with higher scores indicating better performance. Change from baseline at 8 weeks
Primary Change in score on Spelling subtest of the Wide Range Achievement Test 4. Subtest raw scores range from 0 to 57, with higher scores indicating better performance. Change from baseline at 8 weeks
Primary Change in score on Test of Silent Reading Speed and Efficiency. Raw scores range from 0 to 70, with higher scores indicating better performance. Change from baseline at 8 weeks
Secondary Sight word decoding accuracy 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. One time per week for 8 weeks
Secondary Oral reading rate of passages 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. As the first of five tasks of each session for 8 weeks (each session is 1 hour).
Secondary Decoding errors during oral reading of passages 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. As the first of five tasks of each session for 8 weeks (each session is 1 hour).
Secondary Oral spelling of words 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. As the second of five tasks of each session for 8 weeks (each session is 1 hour).
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