Clinical trial NCT04682223: Telerehabilitation for Aphasia (TERRA)
Official title: Center for the Study of Aphasia Recovery (C-STAR): Telerehabilitation for Aphasia (TERRA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia
Stroke
Stroke Rehabilitation
Keywords: aphasia
stroke
telerehabilitation
speech-language therapy
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Medical University of South Carolina
First posted: 2020-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Speech Production Outcome Score (SPOTS)
timeFrame: Compare baseline score to 6 month follow-up (after treatment) score.
Secondary outcomes:
measure: Improvement in overall aphasia severity
timeFrame: Compare baseline score to 6 month follow-up (after treatment) score.
measure: Improvement in quality of life
timeFrame: Compare baseline score to 6 month follow-up (after treatment) score.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Aphasia Lab
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Julius Fridriksson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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