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Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

Primary Purpose

Dysarthria, Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech sessions
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysarthria

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults and children with Downs Syndrome and dysarthria
  • Ages 8 years and older
  • Ability to verbally communicate; follow simple commands and/or imitate others; hear speech at a conversational level; and participate in assessment and speech sessions activities

Exclusion Criteria:

  • Additional serious medical problems which prevent meaningful participation in the study.

Sites / Locations

  • Duke University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral speech treatment

Arm Description

Outcomes

Primary Outcome Measures

Speech intelligibility
Speech intelligibility in sentences scored by naive listeners.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2012
Last Updated
November 22, 2016
Sponsor
Duke University
Collaborators
University of Rhode Island, University of Florida, University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01684670
Brief Title
Intensive Dysarthria Sessions in Adults and Children With Down Syndrome
Official Title
Intensive Dysarthria Sessions in Adults and Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of Rhode Island, University of Florida, University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is designed to investigate the feasibility and treatment effects of a behavioral speech treatment in adults and children with Down Syndrome (DS) and dysarthria. The speech sessions will provide an intensive, articulation-based intervention focused on increasing effort during speech production via use of "clear speech." A single subject multiple baselines across subjects design will be employed in a total of six subjects divided into two groups of three. Changes in dependent measures will be determined by visual inspection, effect size determination, and time series analysis. The study follows accepted procedures in rehabilitation treatment and research and there are minimal foreseeable risks associated with participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysarthria, Down Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral speech treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Speech sessions
Intervention Description
Subjects will be instructed to use clear speech and increased effort when speaking.
Primary Outcome Measure Information:
Title
Speech intelligibility
Description
Speech intelligibility in sentences scored by naive listeners.
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults and children with Downs Syndrome and dysarthria Ages 8 years and older Ability to verbally communicate; follow simple commands and/or imitate others; hear speech at a conversational level; and participate in assessment and speech sessions activities Exclusion Criteria: Additional serious medical problems which prevent meaningful participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harrison N Jones, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

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