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AphasiaTERRANCT04682223

Telerehabilitation for Aphasia (TERRA)

A study testing Semantically-focused therapy tasks and Phonologically-focused therapy tasks in people with Aphasia and Stroke, run by University of South Carolina at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Aphasia, Stroke, Stroke Rehabilitation
What is being tested?
Semantically-focused therapy tasks and Phonologically-focused therapy tasks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
5 May 2021to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Participants must not have previous neurological disease affecting the brain (e.g. history of traumatic brain injury).
  • 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).
  • Participants must not have a history of stroke to the right hemisphere of the brain.
  • Participants must not have a bilateral, cerebellar or brainstem stroke.
  • Participants must not have anything that makes them be 3T MRI incompatible
  • Insufficient intelligible speech to provide accurate responses with discourse/naming.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Sayers, M.S. contact

803-777-2693

ssayers@mailbox.sc.edu

Kelli Powell, B.S. contact

803-777-5051

KELLIAP@mailbox.sc.edu

United States1 site, 1 recruiting
  • University of South Carolina Aphasia Lab

    Columbia, South Carolina, 29201

    Sara Sayers, M.S., 803-777-2693, ssayers@mailbox.sc.edu

    Kelli Powell, B.S., 803-777-5051, kelliap@mailbox.sc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Semantically-focused therapy tasks, Phonologically-focused therapy tasks
Keywords
aphasia, stroke, telerehabilitation, speech-language therapy
Medical subject headings
Aphasia, Stroke, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semantically-focused therapy tasksBehavioural

    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.
  • Phonologically-focused therapy tasksBehavioural

    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).
Study groups in NCT04682223
Study groupRoleWhat they receive
Aphasia Remote Therapy (ART)ExperimentalAll 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.
Receives: Behavioral: Semantically-focused therapy tasks; Behavioral: Phonologically-focused therapy tasks
In-Clinic Therapy (I-CT)Active comparatorAll 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.
Receives: Behavioral: Semantically-focused therapy tasks; Behavioral: Phonologically-focused therapy tasks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech Production Outcome Score (SPOTS)

    A composite measure of naming (items correct on the Philadelphia Naming Test (PNT; Roach et al., 1996) and discourse words per minute (WPM)

    Measured: Compare baseline score to 6 month follow-up (after treatment) score.

Secondary outcomes (2)
  1. Improvement in overall aphasia severity

    As measured by the Western Aphasia Battery-Revised (WAB-R; Kertesz, 2007)

    Measured: Compare baseline score to 6 month follow-up (after treatment) score.

  2. Improvement in quality of life

    As measured by the Stroke Aphasia Quality of Life Scale-39 (SAQOL-39; Hilari et al., 2003)

    Measured: Compare baseline score to 6 month follow-up (after treatment) score.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start5 May 2021
  3. Primary completionJan 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
To conduct a randomized controlled phase II trial aimed at testing whether aphasia therapy delivered by a remote SLP through videoconferencing (aphasia remote therapy; ART) is non-inferior to in-clinic therapy (I-CT).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04682223
Sponsor's protocol ID
Pro00105675
Other IDs
P50DC014664
Acronym
TERRA
Status last verified
Mar 2026
First submitted
18 Dec 2020
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bak TH, Hodges JR. Kissing and dancing-a test to distinguish the lexical and conceptual contributions to noun/verb and action/object dissociation. Preliminary results in patients with frontotemporal dementia. Journal of Neurolinguistics. 2003; 16(2): 169-181.

  • Breitenstein C, Grewe T, Floel A, Ziegler W, Springer L, Martus P, Huber W, Willmes K, Ringelstein EB, Haeusler KG, Abel S, Glindemann R, Domahs F, Regenbrecht F, Schlenck KJ, Thomas M, Obrig H, de Langen E, Rocker R, Wigbers F, Ruhmkorf C, Hempen I, List J, Baumgaertner A; FCET2EC study group. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting. Lancet. 2017 Apr 15;389(10078):1528-1538. doi: 10.1016/S0140-6736(17)30067-3. Epub 2017 Mar 1.

    PubMed 28256356
  • Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2016 Jun 1;2016(6):CD000425. doi: 10.1002/14651858.CD000425.pub4.

    PubMed 27245310
  • Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.

    PubMed 22592672
  • Boyle M. Semantic feature analysis treatment for anomia in two fluent aphasia syndromes. Am J Speech Lang Pathol. 2004 Aug;13(3):236-49. doi: 10.1044/1058-0360(2004/025).

    PubMed 15339233
  • Boyle M, Coelho CA. Application of semantic feature analysis as a treatment for aphasic dysnomia. American Journal of Speech-Language Pathology. 1995; 4(4): 913-919.

  • Cho-Reyes S, Thompson CK. Verb and sentence production and comprehension in aphasia: Northwestern Assessment of Verbs and Sentences (NAVS). Aphasiology. 2012;26(10):1250-1277. doi: 10.1080/02687038.2012.693584.

    PubMed 26379358
  • Conners C, Connelly V, Campbell S, MacLean M, Barnes J. Conners' Continuous Performance Test. Multi-Health Systems, Inc. 2000.

  • Davis JD. The Boston Cooking School Magazine of Culinary Science and Domestic Economics. Boston, MA: Boston Cooking-School Magazine. 1901.

  • Davis A, Wilcox J. Adult Aphasia Rehabilitation: Applied Pragmatics. San Diego, CA: Singular. 1985.

  • Dell GS, Schwartz MF, Martin N, Saffran EM, Gagnon DA. Lexical access in aphasic and nonaphasic speakers. Psychol Rev. 1997 Oct;104(4):801-38. doi: 10.1037/0033-295x.104.4.801.

    PubMed 9337631
  • Edmonds LA, Mammino K, Ojeda J. Effect of Verb Network Strengthening Treatment (VNeST) in persons with aphasia: extension and replication of previous findings. Am J Speech Lang Pathol. 2014 May;23(2):S312-29. doi: 10.1044/2014_AJSLP-13-0098.

    PubMed 24687125
  • Edmonds LA, Nadeau SE, Kiran S. Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval of Content Words in Sentences in Persons with Aphasia. Aphasiology. 2009 Mar 1;23(3):402-424. doi: 10.1080/02687030802291339.

    PubMed 19763227
  • Fotiadou D, Northcott S, Chatzidaki A, Hilari, K. Aphasia blog talk: How does stroke and aphasia affect a person's social relationships? Aphasiology. 2014; 28(11): 1281-1300.

  • Grimes N. Walt Disney's Cinderella. New York, NY: Random House. 2005.

Questions about this trial

What is this clinical trial studying?

A study testing Semantically-focused therapy tasks and Phonologically-focused therapy tasks in people with Aphasia and Stroke, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Sayers, M.S. (803-777-2693, ssayers@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech Production Outcome Score (SPOTS) (time frame: Compare baseline score to 6 month follow-up (after treatment) score.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04682223, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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