Telerehabilitation for Aphasia (TERRA) (TERRA)

May 11, 2023 updated by: Julius Fridriksson, University of South Carolina

Center for the Study of Aphasia Recovery (C-STAR): Telerehabilitation for Aphasia (TERRA)

Speech-language therapy is generally found to be helpful in the rehabilitation of aphasia. However, not all patients with aphasia have access to adequate treatment to maximize their recovery. The goal of this project is to compare the efficacy of telerehabilitation or Aphasia Remote Therapy (ART) to the more traditional In-Clinic Therapy (I-CT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is the leading cause of adult disability in the United States. One of the most debilitating impairments resulting from stroke is aphasia, a language disorder caused by damage to the left hemisphere of the brain. While evidence shows that aphasia therapy improves speech production and communicative quality of life in persons with chronic (>6 months) stroke-induced aphasia, the amount of therapy provided to patients in the United States is typically far less than what is probably necessary to maximize recovery. There are a few important reasons underlying this discrepancy. For example, considerable emphasis is placed on acute and subacute stroke recovery with less therapy focus on the chronic period, when recovery is usually slower. Also, access to rehabilitation services can be limited by the availability of providers (e.g., in rural regions) or by difficulties with transportation logistics related to disabilities and the physical sequelae of stroke. One way to increase access to aphasia therapy is to rely on telerehabilitation (a.k.a., aphasia remote therapy; ART). So far, telerehabilitation in stroke has primarily focused on physical therapy, with only a handful of smaller studies involving aphasia therapy. The purpose of this study is to compare aphasia therapy administered via ART to aphasia therapy administered in person (In-Clinic Therapy; I-CT). We will conduct the first phase II, non-inferiority trial of telerehabilitation for aphasia therapy that is exclusively administered by a speech-language pathologist. Participants with chronic aphasia will be randomized to either a telerehabilitation or aphasia remote therapy (ART) group or an in-clinic therapy (I-CT) group relying on the same therapy approach currently used in our ongoing POLAR study. The outcome measure will focus on speech production and combines correct naming on the Philadelphia Naming Test and correct words produced per minute (CWPM) during discourse. The primary endpoint is change in the outcome measure at 6 months compared to baseline. The non-inferiority margin will be set so that if ART leads to less than 50% improvement than the improvement following I-CT, it will be considered inferior for therapy delivery. Neuroimaging will be used to evaluate how aphasia is shaped by the stroke lesion in combination with residual brain integrity.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • University of South Carolina Aphasia Lab
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julius Fridriksson, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants must have sustained a left hemisphere ischemic or hemorrhagic stroke at least 12 months prior to enrollment.
  2. Participants must primarily speak English for at least the past 20 years.
  3. Participants must be capable of giving informed consent or indicating another to provide informed consent.
  4. Participants must be between 21-80 years of age.
  5. Participants must be magnetic resonance imaging (MRI) compatible (e.g., no metal implants, not claustrophobic) on a 3-Tesla (3T) scanner.

Exclusion Criteria:

  1. Participants must not have previous neurological disease affecting the brain (e.g. history of traumatic brain injury).
  2. Participants must not have severely limited speech production (severe unintelligibility) and/or auditory comprehension that interferes with adequate participation in the therapy provided (i.e., WAB-R Spontaneous Speech rating scale score of 0-1 or WAB-R Comprehension score of 0-1).
  3. Participants must not have a history of stroke to the right hemisphere of the brain.
  4. Participants must not have a bilateral, cerebellar or brainstem stroke.
  5. Participants must not have anything that makes them be 3T MRI incompatible
  6. Insufficient intelligible speech to provide accurate responses with discourse/naming.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aphasia Remote Therapy (ART)

All participants in this group will receive 3 weeks of daily semantically-focused treatment (semantic feature analysis, semantic barrier task and verb network strengthening therapy) and 3 weeks of daily phonologically-focused treatment (phonological components analysis, phonological production task, phonological judgment task). Participants will be randomized to order of treatment.

All treatment will be done remotely with a speech-language pathologist through an online platform using therapy applications. Participants will be provided with teletherapy kits (including an Internet hotspot if needed) to complete the therapy tasks.
Behavioral: Semantically-focused therapy tasks
1) Semantic feature analysis (SFA; Boyle & Coelho, 1995; Boyle, 2004). For each pictured stimulus the participant is prompted to name the picture. Then, s/he is encouraged to produce semantically related words that represent features similar to the target word. 2) Semantic barrier task. This approach includes features of the Promoting Aphasics' Communication Effectiveness (PACE; Davis & Wilcox,1985). The goal of the task is for one participant (e.g., person with aphasia) to describe each card so that the other participant (e.g., clinician) can guess the picture on the card. 3) Verb network strengthening therapy (VNeST; Edmonds et al., 2009; 2014) targets lexical retrieval of verbs and their thematic nouns. The objective of VNeST is for the participant to generate verb-noun associates with the purpose of strengthening the connections between the verb and its thematic roles.
Behavioral: Phonologically-focused therapy tasks
1) Phonological components analysis task (PCA; Leonard et al., 2008). The participant first attempts to name a given picture and then to identify the phonological features of the target words. 2) Phonological production task focuses on the identification of phonological features of targeted, imageable nouns and verbs. It requires the participant to sort picture stimuli based on the number of syllables and then to identify a hierarchy of phonological features. Once each targeted feature is identified for the pair of words, the participant is required to blend the syllables/sounds together. 3) Phonological judgment task relies on computerized presentation of verbs and nouns where participants are required to judge whether pairs of words include similar phonological features (e.g. # of syllables, initial phonemes, final phonemes, rhyming).
Active Comparator: In-Clinic Therapy (I-CT)

All participants in this group will receive 3 weeks of daily semantically-focused treatment (semantic feature analysis, semantic barrier task and verb network strengthening therapy) and 3 weeks of daily phonologically-focused treatment (phonological components analysis, phonological production task, phonological judgment task). Participants will be randomized to order of treatment.

All treatment will be done in person with a speech-language pathologist at the UofSC Aphasia Lab.
Behavioral: Semantically-focused therapy tasks
1) Semantic feature analysis (SFA; Boyle & Coelho, 1995; Boyle, 2004). For each pictured stimulus the participant is prompted to name the picture. Then, s/he is encouraged to produce semantically related words that represent features similar to the target word. 2) Semantic barrier task. This approach includes features of the Promoting Aphasics' Communication Effectiveness (PACE; Davis & Wilcox,1985). The goal of the task is for one participant (e.g., person with aphasia) to describe each card so that the other participant (e.g., clinician) can guess the picture on the card. 3) Verb network strengthening therapy (VNeST; Edmonds et al., 2009; 2014) targets lexical retrieval of verbs and their thematic nouns. The objective of VNeST is for the participant to generate verb-noun associates with the purpose of strengthening the connections between the verb and its thematic roles.
Behavioral: Phonologically-focused therapy tasks
1) Phonological components analysis task (PCA; Leonard et al., 2008). The participant first attempts to name a given picture and then to identify the phonological features of the target words. 2) Phonological production task focuses on the identification of phonological features of targeted, imageable nouns and verbs. It requires the participant to sort picture stimuli based on the number of syllables and then to identify a hierarchy of phonological features. Once each targeted feature is identified for the pair of words, the participant is required to blend the syllables/sounds together. 3) Phonological judgment task relies on computerized presentation of verbs and nouns where participants are required to judge whether pairs of words include similar phonological features (e.g. # of syllables, initial phonemes, final phonemes, rhyming).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Production Outcome Score (SPOTS)
Time Frame: Compare baseline score to 6 month follow-up (after treatment) score.
A composite measure of naming (items correct on the Philadelphia Naming Test (PNT; Roach et al., 1996) and discourse words per minute (WPM)
Compare baseline score to 6 month follow-up (after treatment) score.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in overall aphasia severity
Time Frame: Compare baseline score to 6 month follow-up (after treatment) score.
As measured by the Western Aphasia Battery-Revised (WAB-R; Kertesz, 2007)
Compare baseline score to 6 month follow-up (after treatment) score.
Improvement in quality of life
Time Frame: Compare baseline score to 6 month follow-up (after treatment) score.
As measured by the Stroke Aphasia Quality of Life Scale-39 (SAQOL-39; Hilari et al., 2003)
Compare baseline score to 6 month follow-up (after treatment) score.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Collaborators

Medical University of South Carolina
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Julius Fridriksson, Ph.D., University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00105675
  • P50DC014664 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared via WebDCU™, a web based clinical trial management system developed by the Data Coordination Unit at the Medical University of South Carolina.

IPD Sharing Time Frame

IPD will be shared within 1 year of completion of the study.

IPD Sharing Access Criteria

IPD available upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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