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Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

NCT ID: NCT01684670

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysarthria Down Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioral speech treatment

Group Type EXPERIMENTAL

Speech sessions

Intervention Type BEHAVIORAL

Subjects will be instructed to use clear speech and increased effort when speaking.

Interventions

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Speech sessions

Subjects will be instructed to use clear speech and increased effort when speaking.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rhode Island

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harrison N Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00039730

Identifier Type: -

Identifier Source: org_study_id