Telerehabilitation for Aphasia (TERRA) (TERRA)

• ClinicalTrials.gov Identifier: NCT04682223
• Recruitment Status: Recruiting
• First Posted: December 23, 2020
• Last Update Posted: May 3, 2022
• Sponsor: University of South Carolina
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD); Medical University of South Carolina
• Information provided by (Responsible Party): Julius Fridriksson, University of South Carolina

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Aphasia; Stroke; Stroke Rehabilitation	Behavioral: Semantically-focused therapy tasks; Behavioral: Phonologically-focused therapy tasks	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Outcomes Assessor)
• Masking Description: Raters will be blind to study timepoint, assignment of ART or I-CT, and treatment type (semantically- or phonologically-focused).
• Primary Purpose: Treatment
• Official Title: Center for the Study of Aphasia Recovery (C-STAR): Telerehabilitation for Aphasia (TERRA)
• Actual Study Start Date: May 5, 2021
• Estimated Primary Completion Date: January 1, 2026
• Estimated Study Completion Date: March 31, 2026

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Leigh Ann Spell, Ph.D.; 803-777-2693; SpellL@mailbox.sc.edu

Contact: Hanh Adkins, B.A.; 803-777-4918; HTADKINS@mailbox.sc.edu

Locations

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29425

Contact: Leonardo Bonilha, MD, PhD 843-792-3221 bonilha@musc.edu

Principal Investigator: Julius Fridriksson, PhD

University of South Carolina; Recruiting

Columbia, South Carolina, United States, 29208

Contact: Leigh Ann Spell, PhD, CCC-SLP 803-777-2693 spelll@mailbox.sc.edu

Principal Investigator: Julius Fridriksson, PhD

Sponsors and Collaborators

University of South Carolina

National Institute on Deafness and Other Communication Disorders (NIDCD)

Medical University of South Carolina

Investigators

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

More Information

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• Responsible Party: Julius Fridriksson, Primary Investigator, University of South Carolina
• ClinicalTrials.gov Identifier: NCT04682223
• Other Study ID Numbers: Pro00105675; P50DC014664 ( U.S. NIH Grant/Contract )
• First Posted: December 23, 2020
• Last Update Posted: May 3, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code
• Time Frame: IPD will be shared within 1 year of completion of the study.
• Access Criteria: IPD available upon request.
• URL: https://dcu.musc.edu/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Julius Fridriksson, University of South Carolina:

aphasia; stroke; telerehabilitation; speech-language therapy

Additional relevant MeSH terms:

Stroke; Aphasia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations