Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04682223
Status:
RECRUITING
Last Update Posted:
2023-05-12
First Post:
2020-12-18
Brief Title:
Telerehabilitation for Aphasia TERRA
Sponsor:
University of South Carolina
Organization:
University of South Carolina
Study Overview
Official Title:
Center for the Study of Aphasia Recovery C-STAR Telerehabilitation for Aphasia TERRA
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TERRA
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 eg 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 aka 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50DC014664 | NIH | None | httpsreporternihgovquickSearchP50DC014664 |