Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

Down Syndrome Clinical Trial

Official title:

Intensive Dysarthria Sessions in Adults and Children With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684670
• Other study ID #: Pro00039730
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: November 22, 2016
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Down Syndrome
• Dysarthria
• Syndrome

Intervention

Behavioral:
• Speech sessions
Subjects will be instructed to use clear speech and increased effort when speaking.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	University of Florida, University of North Carolina, Chapel Hill, University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech intelligibility	Speech intelligibility in sentences scored by naive listeners.	3-6 months	No