NCT03662243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

September 3, 2018

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Sight word decoding accuracy

    One time per week for 8 weeks

  • Oral reading rate of passages

    As the first of five tasks of each session for 8 weeks (each session is 1 hour).

  • Decoding errors during oral reading of passages

    As the first of five tasks of each session for 8 weeks (each session is 1 hour).

  • Oral spelling of words

    As the second of five tasks of each session for 8 weeks (each session is 1 hour).

Study Arms (1)

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

Interventions

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.

Acquired brain injury participants

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Survivor of acquired brain injury
  • Exhibits alexia and/or agraphia
  • Past or current client of Quality Living, Inc., Omaha, Nebraska
  • Fluent speaker of English

You may not qualify if:

  • Vision impairment prohibiting reading of 24-point text
  • Auditory comprehension problems precluding understanding of consent/assent information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

Brain InjuriesDyslexiaAgraphia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Karen Hux, Ph.D.

    Quality Living, Inc., Omaha, Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 7, 2018

Study Start

August 30, 2018

Primary Completion

September 15, 2020

Study Completion

September 15, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations