NCT01790880

Brief Summary

The purpose of this study is to evaluate whether a computerized speech-language treatment delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing) results in improved written communication skills of study participants with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

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

Study Start

First participant enrolled

February 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

4.8 years

First QC Date

February 11, 2013

Last Update Submit

March 17, 2020

Conditions

AphasiaStroke

Keywords

AphasiaStrokeSpeech Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment

    Change from baseline to 6 weeks

Secondary Outcomes (5)

  • Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)

    Change from baseline to 6 weeks

  • Written Language Sample Analysis

    Change from baseline to 6 weeks

  • Communicative Effectiveness Index (CETI)

    Change from baseline to 6 weeks

  • ASHA Quality of Communication Life Scale (QCL)

    Change from baseline to 6 weeks

  • Community Integration Questionnaire (CIQ)

    Change from baseline to 6 weeks

Study Arms (2)

ORLA

ACTIVE COMPARATOR

Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system, for 90 minutes per day, 6 days per week for 6 weeks.

Behavioral: ORLA

ORLA + Writing

EXPERIMENTAL

Practice on "ORLA + writing" computer program, 90 minutes per day, 6 days per week, for 6 weeks.

Behavioral: ORLA + Writing

Interventions

ORLABEHAVIORAL

Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.

ORLA
ORLA + WritingBEHAVIORAL

Treatment includes writing of sentences in combination with ORLA

ORLA + Writing

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
  • an Aphasia Quotient score on the Western Aphasia Battery of 50-85.
  • months post injury
  • premorbidly right handed, determined by Edinburgh Handedness Inventory
  • completed at least an eighth grade education
  • premorbidly literate in English
  • visual acuity may be corrected but must be sufficient for reading visual stimuli on computer screen
  • auditory acuity may be aided but must be sufficient for hearing auditory stimuli in ORLA program

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)

Center for Aphasia Research and Treatment, Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

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
Senior Research Scientist

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2017

Study Completion

March 1, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

US(1)