Acquired Brain InjuryNCT03662243
Treatment for Reading and Writing Deficits Following Acquired Brain Injury
An observational study of Acquired Brain Injury and Alexia, run by Quality Living, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Acquired Brain Injury, Alexia, Agraphia
- What is being tested?
- Multicomponent reading and writing treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 15 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Survivor of acquired brain injury
- Exhibits alexia and/or agraphia
- Past or current client of Quality Living, Inc., Omaha, Nebraska
- Fluent speaker of English
Who cannot join
- Vision impairment prohibiting reading of 24-point text
- Auditory comprehension problems precluding understanding of consent/assent information
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acquired Brain Injury, Alexia, Agraphia
- Being tested
- Multicomponent reading and writing treatment
- Medical subject headings
- Brain Injuries, Dyslexia, Agraphia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent reading and writing treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acquired brain injury participants | People with acquired alexia and/or agraphia secondary to brain injury who participate in the reading/writing intervention. Receives: Behavioral: Multicomponent reading and writing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
Change in score on Test of Silent Reading Speed and Efficiency.
Raw scores range from 0 to 70, with higher scores indicating better performance.
Measured: Change from baseline at 8 weeks
Secondary outcomes (4)
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.
Measured: One time per week for 8 weeks
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.
Measured: As the first of five tasks of each session for 8 weeks (each session is 1 hour).
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.
Measured: As the first of five tasks of each session for 8 weeks (each session is 1 hour).
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.
Measured: As the second of five tasks of each session for 8 weeks (each session is 1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start30 Aug 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quality Living, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Hux, Quality Living, Inc.
- Investigators
- Karen Hux, Ph.D., Principal investigator, Quality Living, Inc., Omaha, Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662243
- Sponsor's protocol ID
- Reading/writing treatment
- Status last verified
- Mar 2021
- First submitted
- 3 Sep 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Reading and Writing Deficits Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03662243
- Acronym / sponsor ID
- Reading/writing treatment
- Conditions
- Acquired Brain Injury, Alexia, Agraphia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Quality Living, Inc.University, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acquired brain injury participants | – | Behavioral: Multicomponent reading and writing treatmentPeople with acquired alexia and/or agraphia secondary to brain injury who participate in the reading/writing intervention. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Survivor of acquired brain injury
- Exhibits alexia and/or agraphia
- Past or current client of Quality Living, Inc., Omaha, Nebraska
- Fluent speaker of English
Key exclusion criteria (2 listed)
- Vision impairment prohibiting reading of 24-point text
- Auditory comprehension problems precluding understanding of consent/assent information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent reading and writing treatmentIntervention 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. | Behavioural | Acquired brain injury participants |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Sight word decoding accuracy
Time frame: One time per week for 8 weeks
Oral reading rate of passages
Time frame: As the first of five tasks of each session for 8 weeks (each session is 1 hour).
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).
Oral spelling of words
Time frame: As the second of five tasks of each session for 8 weeks (each session is 1 hour).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Hux, Ph.D. principal investigator
Quality Living, Inc., Omaha, Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Brain Injury and Alexia, run by Quality Living, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on Word Attack subtest of the Woodcock-Johnson III Test of Achievement. (time frame: Change from baseline at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.