Translation and Clinical Implementation of a Test of Lang... | NCT03635554

Studies
Translation and Clinical Implementation of a Test of Language and Short-term Memory in Aphasia

NCT03635554

Sponsor

Temple University

Status

Unknown status

Last Update Posted

Apr 10, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Aphasia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2017Actual

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Nov 30, 2025Estimated

First Submitted Date

Aug 15, 2018

First Submission Date that Met QC Criteria

Aug 15, 2018

First Posted Date

Aug 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2024

Last Update Posted Date

Apr 10, 2024Actual

Name	Class
University of Washington	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This project aims to develop a clinically feasible version of a laboratory-developed assessment battery for language and verbal short-term memory difficulties in aphasia.

Detailed Description

Over five years, we will develop a clinically feasible test that can be used to assess in-depth the language and verbal short-term memory abilities of individuals with aphasia (Called the TALSA - Temple Assessment of Language and Short-term memory in Aphasia. Based on a test that we have developed and tested over the past decade, we will create a shorter version that can be used by clinicians in a rehabilitation setting. The data to support this development will come from two sources: (1) clinicians in rehabilitation facilities who will use the new clinical test and provide feedback on the test (administration, value etc) and (2) people with aphasia who will be administered the longer version to help us identify the best test items in the laboratory version of the TALSA to be carried over to the shorter clinical version.

We are recruiting individuals with aphasia as well as people without aphasia (to serve as controls) to help with development of this assessment battery. The battery consists of between 15 and 20 subtests that assess many aspects of language and verbal short-term memory.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportions correct on subtests of the Test of Language and Short-term Memory in Aphasia (TALSA)	Participants will be administered 15-20 subtests of the TALSA that assess aspects of language (phoneme discrimination, sentence comprehension) and short-term memory (e.g., repetition span) abilities. Their responses on these measures will be evaluated in a item response analysis to determine which items are ideal to use in a smaller version of this test that is feasible to use in clinical practice. Another group of people with aphasia will be administered the clinical version (when it is complete) to develop normative data for that assessment battery.	two to three years December 1, 2017 through December 15, 2017 through November 30, 2022.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

. single or multiple left hemisphere lesions
at least one year post-stroke.
high-school educated
negative histories for mental illness and alcohol/substance abuse.
passed an audiometric pure-tone, air conduction screening at 25 dB HL at 1K, 2K and 4K Hz for at least one ear.

Exclusion Criteria:

English as a second language Right hemisphere stroke Less than 6 months post-onset of stroke.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Participants with aphasia will have single or multiple left hemisphere lesions, but no right hemisphere lesions. They can be between the ages of 21 and 80. Their aphasia can range in severity from mild to severe and can be of any type except global aphasia. Their language output can be fluent or nonfluent and their comprehension can be mild moderately impaired.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nadine Martin, Ph.D.	Temple University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temple University		Philadelphia	Pennsylvania	19122	United States

Condition Browse Module

MeSH Terms

ID	Term
D001037	Aphasia

Ancestor Terms

ID	Term
D013064	Speech Disorders
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided