NCT04138940

Brief Summary

The purpose of this study is to evaluate how changing conditions of speech-language treatment (namely, amount of repetition and distribution of practice schedule) affects the language outcome of participants with aphasia following a stroke. Using a computer based speech and language therapy program, participants will practice conversational scripts that are either short or long. Participants will practice for either 2 weeks (5 days a week) or for 5 weeks (2 days a week).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

4.2 years

First QC Date

October 23, 2019

Last Update Submit

May 22, 2025

Conditions

Keywords

StrokeSpeech and Language TherapySpeech and Language TreatmentCommunication DisordersLanguage Disorders

Outcome Measures

Primary Outcomes (1)

  • Generalization - Conversation with a communication partner using the lines of the trained script

    Number of correct information units produced during conversation with communication partner (speech-language pathologist) using the lines of the trained script.

    Change from baseline to immediately post treatment

Secondary Outcomes (3)

  • Generalization - Conversation with a communication partner about the topic of the trained script

    Change from baseline to immediately post treatment

  • Acquisition of trained script - Accuracy

    Change from baseline to immediately post treatment

  • Acquisition of trained script - Rate

    Change from baseline to immediately post treatment

Other Outcomes (4)

  • Maintenance - Conversation with a communication partner using the lines of the trained script

    Change from baseline to six weeks post treatment.

  • Maintenance - Conversation with a communication partner about the topic of the trained script

    Change from baseline to six weeks post treatment.

  • Maintenance of trained script - Accuracy

    Change from baseline to six weeks post treatment

  • +1 more other outcomes

Study Arms (4)

Distributed, Short Script

EXPERIMENTAL

Participant practices for 1 hour, 2 days a week for 5 weeks using a 5 sentence-long script.

Behavioral: Script Training

Distributed, Long Script

EXPERIMENTAL

Participant practices for 1 hour, 2 days a week for 5 weeks using a 10 sentence-long script.

Behavioral: Script Training

Massed, Short Script

EXPERIMENTAL

Participant practices for 1 hour, 5 days a week for 2 weeks using a 5 sentence-long script.

Behavioral: Script Training

Massed, Long Script

EXPERIMENTAL

Participant practices for 1 hour, 5 days a week for 2 weeks using a 10 sentence-long script.

Behavioral: Script Training

Interventions

Script TrainingBEHAVIORAL

Participant uses a computer program to practice scripts with a virtual therapist.

Distributed, Long ScriptDistributed, Short ScriptMassed, Long ScriptMassed, Short Script

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women with diagnosis of aphasia
  • Left-hemisphere stroke
  • Aphasia Quotient score between 40-80 on the Western Aphasia Battery-Revised
  • At least 6 months post stroke
  • Completed at least eighth grade education
  • Premorbidly literate in English
  • Visual acuity no worse than 20/100 corrected in the better eye
  • Auditory acuity no worse than 30 dB HL on pure tone testing, aided in better ear
  • Not receiving speech-language therapy at the time of study

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
  • Any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered
  • Active substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan Abilitylab

Chicago, Illinois, 60611, United States

Location

Related Links

MeSH Terms

Conditions

AphasiaStrokeCommunication DisordersSpeechLanguage Disorders

Condition Hierarchy (Ancestors)

Speech DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Study Officials

  • Leora Cherney, PhD, CCC-SLP

    Shirley Ryan Abilitylab, Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

September 21, 2020

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations