Telerehabilitation for Aphasia (TERRA)

NCT04682223 | Recruiting

• 2 other identifiers: Pro00105675P50DC014664
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Aphasia; Stroke; Stroke Rehabilitation

Keywords

aphasia; stroke; telerehabilitation; speech-language therapy

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (2)

• Improvement in overall aphasia severity

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

• Improvement in quality of life

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

Study Arms (2)

Aphasia Remote Therapy (ART)

EXPERIMENTAL

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; Behavioral: Phonologically-focused therapy tasks

In-Clinic Therapy (I-CT)

ACTIVE COMPARATOR

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; Behavioral: Phonologically-focused therapy tasks

Interventions

Semantically-focused therapy tasks BEHAVIORAL

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.

Aphasia Remote Therapy (ART); In-Clinic Therapy (I-CT)

Phonologically-focused therapy tasks BEHAVIORAL

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).

Aphasia Remote Therapy (ART); In-Clinic Therapy (I-CT)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of South Carolina Aphasia Lab

Columbia, South Carolina, 29201, United States

RECRUITING

Related Publications (32)

• 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.

  BACKGROUND

• 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.

  PMID: 28256356 BACKGROUND

• 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.

  PMID: 27245310 BACKGROUND

• 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.

  PMID: 22592672 BACKGROUND

• 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).

  PMID: 15339233 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26379358 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 9337631 BACKGROUND

• 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.

  PMID: 24687125 BACKGROUND

• 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.

  PMID: 19763227 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• Hilari K, Byng S, Lamping DL, Smith SC. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39): evaluation of acceptability, reliability, and validity. Stroke. 2003 Aug;34(8):1944-50. doi: 10.1161/01.STR.0000081987.46660.ED. Epub 2003 Jul 10.

  PMID: 12855827 BACKGROUND

• Howard D, Patterson K, Franklin S, Orchard-Lisle V, Morton J. Treatment of word retrieval deficits in aphasia. A comparison of two therapy methods. Brain. 1985 Dec;108 ( Pt 4):817-29.

  PMID: 4075074 BACKGROUND

• Kay J, Lesser R, Coltheart M. PALPA: Psycholinguistic assessments of language processing in aphasia. New York, NY: Psychology Press. 2009.

  BACKGROUND

• Kertesz A. Western Aphasia Battery-Revised. San Antonio, TX: Pearson. 2007.

  BACKGROUND

• Lau M. Who made that? New York Times Magazine, June 7, 2013.

  BACKGROUND

• Laver KE, Adey-Wakeling Z, Crotty M, Lannin NA, George S, Sherrington C. Telerehabilitation services for stroke. Cochrane Database Syst Rev. 2020 Jan 31;1(1):CD010255. doi: 10.1002/14651858.CD010255.pub3.

  PMID: 32002991 BACKGROUND

• Leonard C, Rochon E, Laird, L. Treating naming impairments in aphasia: Findings from a phonological components analysis treatment. Aphasiology. 2008; 22(9): 923-947.

  BACKGROUND

• Menn L, Ramsberger G, Estabrooks NH. A linguistic communication measure for aphasic narratives. Aphasiology. 1994; 8(4): 343-59.

  BACKGROUND

• Monsell S. On the relation between lexical input and output pathways for speech. In: Language Perception and Production: Relationships between Listening, Speaking, Reading and Writing. Cognitive science series. Academic Press. 1987: 273-311.

  BACKGROUND

• Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.

  PMID: 27563386 BACKGROUND

• Roach A, Schwartz MF, Martin N, Grewal RS, Brecher A. The Philadelphia Naming Test (PNT): Scoring and rationale. Clinical Aphasiology. 1996; 24: 121-134.

  BACKGROUND

• Simmons-Mackie N, Worral L, Murray L, Enderby, P. The top ten: Best practice recommendations for aphasia. Aphasiology. 2016; 31(2): 1-21.

  BACKGROUND

• Strand EA, Duffy JR, Clark HM, Josephs K. The Apraxia of Speech Rating Scale: a tool for diagnosis and description of apraxia of speech. J Commun Disord. 2014 Sep-Oct;51:43-50. doi: 10.1016/j.jcomdis.2014.06.008. Epub 2014 Jul 14.

  PMID: 25092638 BACKGROUND

• Utianski RL, Duffy JR, Clark HM, Strand EA, Botha H, Schwarz CG, Machulda MM, Senjem ML, Spychalla AJ, Jack CR Jr, Petersen RC, Lowe VJ, Whitwell JL, Josephs KA. Prosodic and phonetic subtypes of primary progressive apraxia of speech. Brain Lang. 2018 Sep;184:54-65. doi: 10.1016/j.bandl.2018.06.004. Epub 2018 Jul 4.

  PMID: 29980072 BACKGROUND

• Venkatesh V, Davis FD. A model of the antecedents of perceived ease of use: Development and test. Decision Sciences. 1996; 27(3): 451-481.

  BACKGROUND

• Wechsler D. Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio,TX: NCS Pearson. 2008.

  BACKGROUND

• Winkler M, Bedford V, Northcott S, Hilari H. Aphasia blog talk: How does stroke and aphasia affect the carer and their relationship with the person with aphasia? Aphasiology. 2014; 28(11): 1301-1319.

  BACKGROUND

MeSH Terms

Conditions

Aphasia; Stroke; Communication Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Language 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; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Julius Fridriksson, Ph.D.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Sayers, M.S.

CONTACT

803-777-2693; ssayers@mailbox.sc.edu

Kelli Powell, B.S.

CONTACT

803-777-5051; KELLIAP@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters will be blind to study timepoint, assignment of ART or I-CT, and treatment type (semantically- or phonologically-focused).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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).

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: May 5, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD will be shared within 1 year of completion of the study.
• Access Criteria: IPD available upon request.

Locations

US (1)