Skip to main content
OpenTrials
Completed

NCT Number: NCT01684670

Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dysarthria Abnormalities, Multiple Articulation Disorders Chromosome Disorders Communication Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Speech sessions

Behavioral

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

Primary outcomes

  1. Speech intelligibility

    Time frame: 3-6 months

    Speech intelligibility in sentences scored by naive listeners.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of Florida
  • University of North Carolina, Chapel Hill
  • University of Rhode Island

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2012
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.