Trial record 7 of 7 for:    "Articulation Disorders"

Efficacy of Voice Treatment for Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Colorado, Boulder.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT00123084
First received: July 20, 2005
Last updated: May 6, 2011
Last verified: May 2011
  Purpose

The purpose of the research study is to determine the effects of two different kinds of speech treatment on certain behaviors in individuals with parkinson's disease. These behaviors include speech, voice, related communication behaviors, swallowing and body movement.


Condition Intervention Phase
Parkinson's Disease
Dysphagia
Dysarthria
Behavioral: Voice/Respiration Treatment
Behavioral: Speech/Articulation Treatment
Behavioral: No intervention (PD)
Behavioral: HC control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Voice Treatment for Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Boulder:

Primary Outcome Measures:
  • Voice intensity; voice fundamental frequency; articulatory acoustics; physiological voice function; speech intelligibility; swallowing function; non-verbal communication behaviors; limb function; neural imaging; neuropsychological functioning [ Time Frame: 8-9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 620
Study Start Date: March 2002
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Voice/Respiration Treatment
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.
Experimental: 2 Behavioral: Speech/Articulation Treatment
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
No Intervention: 3 Behavioral: No intervention (PD)
Subjects with PD in the no intervention group will receive no therapy during the study. Subjects will receive therapy after completion of the study.
No Intervention: 4 Behavioral: HC control
Subjects without PD in the HC control group will not receive any therapy, either during or after completion of the study.

Detailed Description:

This is a research project designed to look at various areas of function, such as speech, voice, swallowing, related communication behaviors and body movement of individuals with idiopathic Parkinson disease (PD) and to investigate how two different forms of speech therapy affect these areas.

We are asking up to 620 individuals to participate in this study in several different ways. Specifically, there is an experimental group (ExpG), questionnaire group (QG) and communication partner group (CPG). The ExpG will be composed of individuals with PD and the healthy age and gender matched controls (HC)(Up to 140 total will be asked, 80 expected to complete the study). The QG will include the significant others, family members, and friends of the ExpG (Up to 140 will be asked, 80 expected to complete the study). The CPG will be made up of friends of the ExpG (Up to 340 will be asked, 240 expected to complete the study).Some individuals in the ExpG may not pass the initial screenings. As a result, their QG and CPG will no longer need to participate. Therefore, the actual number of individuals who will complete the study is expected to be much less.

There are 10 PHASES of this study. The initial PHASES (1,2,3) are screening PHASES to determine if the individual is a good candidate for this study. PHASES 4, 6 and 10 are PHASES of recording data and PHASE 5 is treatment. PHASES 7, 8 and 9 are additional assessments. The total duration of the Subjects (Ss) participation from the time Ss sign the consent to the completion of the last phase (PHASE 10) is approximately10 months.

PHASE 1: ENT/CLINICAL VOICE AND SPEECH SCREEN PHASE 2: SWALLOW SCREEN AND ASSESSMENT PHASE 3: THINKING SKILLS SCREEN AND ASSESSMENT After the completion of PHASES 1-3, the research team will look at the data collected and determine if the Ss meet the criteria to participate in this study. If asked to participate, Ss will be assigned to one of four groups and then continue with PHASE 4.

PHASE 4: INITIAL DATA RECORDINGS All of the procedures in PHASE 4 will be done two times before the treatment PHASE 5. Each recording will take approximately 2-2.5 hours.

PHASE 5: TREATMENT PHASE 6: POST TREATMENT PHASE DATA RECORDINGS PHASE 7: FOLLOW-UP ENT EVALUATION PHASE 8: FOLLOW-UP SWALLOW EVALUATION PHASE 9: FOLLOW-UP THINKING SKILLS EVALUATION PHASE 10: 6-MONTH POST TREATMENT PHASE DATA RECORDINGS

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's Disease (IPD)
  • None or mild dementia
  • None, mild or moderate depression
  • Mild, moderate or severe speech, voice, and swallowing disorder

Exclusion Criteria:

  • Severe depression
  • Moderate or severe dementia
  • Symptoms of another neurological condition other than or in addition to IPD or drug abuse
  • Head or neck cancer
  • Significant history of gastrointestinal disease or surgery
  • Speech or voice disorders unrelated to IPD
  • Neurosurgery, not for management of PD symptoms
  • Laryngeal pathology/surgery
  • Full-course Lee Silverman Voice Treatment (LSVT®)
  • Smoked in last four years
  • Absence of speech, voice or swallowing disorder
  • Severe temporomandibular joint disorder
  • Pregnancy (or the possibility of pregnancy)
  • Hearing loss unexpected for his/her chronological age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123084

Contacts
Contact: Heather L Gustafson, MA, CCC-SLP 303-534-0324 heather.gustafson@colorado.edu

Locations
United States, Colorado
National Center for Voice and Speech-Denver; An Affiliate of the unniversity of Colorado Recruiting
Denver, Colorado, United States, 80204
Contact: Heather Gustafson, MA, CCC-SLP    303-534-0324    heather.gustafson@colorado.edu   
United States, Texas
University of Texas HSC San Antonio Recruiting
San Antonio, Texas, United States
Sub-Investigator: Peter Fox, PhD         
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
Principal Investigator: Lorraine Ramig, PhD, CCC-SLP Professor, University of Colorado-Boulder; Senior Scientist, National Center for Voice and Speech-Denver; Adjunct Professor, Columbia University-NYC
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Lorraine Ramig, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT00123084     History of Changes
Other Study ID Numbers: R01 DC01150, R01DC001150
Study First Received: July 20, 2005
Last Updated: May 6, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Boulder:
Parkinson's disease
Swallowing difficulties
speech
voice

Additional relevant MeSH terms:
Articulation Disorders
Deglutition Disorders
Dysarthria
Parkinson Disease
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 19, 2014