Telerehabilitation for Aphasia (TERRA)

University of South Carolina

Status: Enrolling

Conditions: Stroke; Stroke Rehabilitation; Aphasia

Treatments: Behavioral: Semantically-focused therapy tasks; Behavioral: Phonologically-focused therapy tasks

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04682223

P50DC014664 (U.S. NIH Grant/Contract)

Pro00105675

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Aphasia Remote Therapy (ART)

Experimental group

Description:

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.

Treatment:

Behavioral: Phonologically-focused therapy tasks

Behavioral: Semantically-focused therapy tasks

In-Clinic Therapy (I-CT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Phonologically-focused therapy tasks

Behavioral: Semantically-focused therapy tasks