Home Program Practice for People With Language Disorders... | NCT04543084

Studies
Home Program Practice for People With Language Disorders After Stroke

NCT04543084

Sponsor

Duquesne University

Status

Completed

Last Update Posted

Sep 1, 2023Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Aphasia
Stroke

Interventions

Logbook

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2021Actual

Primary Completion Date

Sep 6, 2022Actual

Completion Date

Sep 6, 2022Actual

First Submitted Date

Aug 27, 2020

First Submission Date that Met QC Criteria

Sep 8, 2020

First Posted Date

Sep 9, 2020Actual

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

Aug 31, 2023

Last Update Posted Date

Sep 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single-Subject Design	Other	Each participant will go through a baseline phase and then an intervention phase.	Behavioral: Logbook

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Logbook	Behavioral	Participants will record practice in a logbook.	Single-Subject Design

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in minutes of practice	The number of minutes practiced	Up to 11 weeks
Change in percentage of adherence to practice goal	The amount of practice compared to the goal	Up to 11 weeks

Secondary Outcomes

Measure	Description	Time Frame
Reading comprehension	As measured by performance on the Reading Comprehension Battery for Aphasia-2 (RCBA-2). A higher score is better.	At first session and at last session time in between up to 5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 6 months post left hemisphere stroke with a diagnosis of aphasia
must have self-reported interest in working to improve reading comprehension
access to the Internet
speak English as a primary language

Exclusion Criteria:

significant visual or hearing impairment as determined by "aphasia-friendly" and age-appropriate screening
actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested
severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elena V. Donoso Brown, PhD	Duquesne University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duquesne University		Pittsburgh	Pennsylvania	15228	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001037	Aphasia
D020521	Stroke

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided