Telerehabilitation for Aphasia (TERRA)

Stroke Clinical Trial

— TERRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04682223
• Other study ID #: Pro00105675
• Secondary ID: P50DC014664
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2023
• Source: University of South Carolina
• Contact: Sara Sayers, M.S.
• Phone: 803-777-2693
• Email: ssayers[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Stroke
• Stroke Rehabilitation

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of South Carolina Aphasia Lab	Columbia	South Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in overall aphasia severity	As measured by the Western Aphasia Battery-Revised (WAB-R; Kertesz, 2007)	Compare baseline score to 6 month follow-up (after treatment) score.
Secondary	Improvement in quality of life	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.