Web-Based Treatment for Aphasia

NCT04413136 | Completed

• 1 other identifier: STU00000150
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective randomized clinical trial implements an innovative broadband web-based treatment program for individuals with chronic aphasia, and evaluates its efficacy. The treatment, Oral Reading for Language in Aphasia (ORLA), has been shown to be efficacious when provided by a speech-language pathologist. The treatment has been computerized and the current version of ORLA uses state-of-the-art virtual therapist technology that allows the individual with aphasia to read aloud, and ultimately speak, sentences at the same time as the words are produced by a perceptive, life-like, animated computer agent, using visible speech. In this clinical trial, ORLA treatment is delivered via the internet and outcomes are compared to a placebo computer treatment.

Conditions

Aphasia

Keywords

Aphasia; Stroke; Rehabilitation; Computer

Outcome Measures

Primary Outcomes (1)

• Western Aphasia Battery Revised Language Quotient (LQ)

  Performance on measures of auditory comprehension, oral expression, reading comprehension and written expression on the WAB-R LQ scale which goes from 0-100. A higher score indicates better performance.

  Change from baseline to immediately following 6 weeks of treatment

Secondary Outcomes (1)

• Western Aphasia Battery Revised Language Quotient (LQ)

  Change from baseline to 6 weeks after the end of treatment.

Study Arms (2)

Web-ORLA

EXPERIMENTAL

Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks. The participant is presented with 3-5 word (level 1) or 8-10 word (level 2) sentences, depending upon the severity of the aphasia. Each sentence is chosen by the software program at random from a group of 150 sentences. The participant is instructed to look, listen, and point to words spoken by the virtual therapist, read highlighted words aloud, and then read the sentence aloud, both chorally with the virtual therapist and independently.

Behavioral: Web-ORLA

Control

PLACEBO COMPARATOR

Administered 90 minutes a day, six days a week ( i.e. nine hours of computer treatment per week) for a total of six weeks. A commercially available game, Bejeweled 2, by PopCap. Participants use loaned 13-in laptop computers to access the Bejeweled interface, which displays an 8 X 8 grid of gems of varying shapes and colors. The objective is to match three gems of the same color and shape to score points and advance to more difficult levels.

Behavioral: Control

Interventions

Web-ORLA BEHAVIORAL

Web-ORLA

Control BEHAVIORAL

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 20-80.
• \> 6 months post injury
• completed at least an eighth grade education
• premorbidly literate in English
• sufficient auditory and visual acuity to interact with a laptop
• not receiving other speech/language treatment for at least one month prior to or during the 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Northwestern University: collaborator
• University of Colorado, Boulder: collaborator

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leora R 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: May 29, 2020
• First Posted: June 2, 2020
• Study Start: January 7, 2008
• Primary Completion: October 27, 2010
• Study Completion: September 29, 2011
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share