University of South Carolina Aphasia Lab
Columbia, South Carolina, 29201, United States
Location status: Recruiting
Location contact
Julius Fridriksson, Ph.D
PRINCIPAL_INVESTIGATOR
Kelli Powell, B.S.
CONTACT
Sara Sayers, M.S.
CONTACT
NCT Number: NCT04682223
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).
Interested in participating?
Request Info21 year–80 year
All sexes
Interventional
Not applicable
Columbia, South Carolina, 29201, United States
Location status: Recruiting
Julius Fridriksson, Ph.D
PRINCIPAL_INVESTIGATOR
Kelli Powell, B.S.
CONTACT
Sara Sayers, M.S.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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)
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)
Contact information is provided by the study sponsor or research team.
Kelli Powell, B.S.
CONTACT
Sara Sayers, M.S.
CONTACT
University of South Carolina
Other
Center for the Study of Aphasia Recovery (C-STAR): Telerehabilitation for Aphasia (TERRA)
Acronym: TERRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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