NCT03773419

Brief Summary

People with aphasia have difficulty with writing and often struggle to use electronic communication that connects people to one another. The goal of this project is to evaluate the extent to which a novel treatment (T-WRITE) improves written language function and the use of text messaging; we also evaluate whether there are subsequent positive effects on the participant's social connectedness and ultimately health-related quality of life (HRQOL). T-WRITE involves choral reading and repeated writing of sentences via texting. Participants work intensively and independently at home on a laptop computer. A virtual therapist directs the participant to practice copying and independently writing phrases and short sentences using the typing feature on a cellular phone. The specific objective of this randomized clinical trial is to compare T-WRITE to ORLA+WTG, a similar treatment that targets written expression using handwriting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

December 10, 2018

Last Update Submit

October 25, 2022

Conditions

Aphasia

Keywords

Stroke-related aphasiaRehabilitationWritingTexting

Outcome Measures

Primary Outcomes (1)

  • Western Aphasia Battery-Revised (WAB-R) Writing subtest

    Performance-based measure of written language; score ranges from 0 - 100

    Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)

Secondary Outcomes (2)

  • Stroke and Aphasia Quality of Life Scale (SAQOL-39)

    Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)

  • The Friendship Scale

    Change from pre-treatment to post-treatment (i.e. following completion of 36 hours of treatment at 4 weeks)

Study Arms (2)

Texting Intervention (T-WRITE)

EXPERIMENTAL

Computer-based treatment targeting written language via texting (90 minutes a day, 5 days a week for 4 weeks)

Behavioral: Texting Intervention (T-WRITE)

HandWriting Intervention (ORLA+WTG)

ACTIVE COMPARATOR

Computer-based treatment targeting written language via handwriting (90 minutes a day, 5 days a week for 4 weeks)

Behavioral: HandWriting Intervention (ORLA+WTG)

Interventions

Texting Intervention (T-WRITE)BEHAVIORAL

Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone

Texting Intervention (T-WRITE)
HandWriting Intervention (ORLA+WTG)BEHAVIORAL

Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper

HandWriting Intervention (ORLA+WTG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
  • Aphasia Quotient score on the Western Aphasia Battery-Revised of 40-85.
  • \> 6 months post injury
  • premorbidly right handed, determined by Edinburgh Handedness Inventory
  • completed at least an eighth grade education
  • premorbid proficiency in English by self-report

You may not qualify if:

  • any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's Dementia, traumatic brain injury.
  • active substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

James Madison University

Harrisonburg, Virginia, 22807, United States

Location

Related Publications (1)

  • Kinsey LE, Lee JB, Larkin EM, Cherney LR. Texting Behaviors of Individuals With Chronic Aphasia: A Descriptive Study. Am J Speech Lang Pathol. 2022 Jan 18;31(1):99-112. doi: 10.1044/2021_AJSLP-20-00287. Epub 2021 Jun 1.

    PMID: 34061572DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leora Cherney, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 12, 2018

Study Start

September 20, 2018

Primary Completion

August 13, 2021

Study Completion

September 30, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)