Efficacy of Voice Treatment for Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00123084|
Recruitment Status : Unknown
Verified May 2011 by University of Colorado, Boulder.
Recruitment status was: Recruiting
First Posted : July 22, 2005
Last Update Posted : May 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Dysphagia Dysarthria||Behavioral: Voice/Respiration Treatment Behavioral: Speech/Articulation Treatment Behavioral: No intervention (PD) Behavioral: HC control||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||620 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Voice Treatment for Parkinson's Disease|
|Study Start Date :||March 2002|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||December 2012|
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.
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123084
|Contact: Heather L Gustafson, MA, CCC-SLPfirstname.lastname@example.org|
|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 email@example.com|
|United States, Texas|
|University of Texas HSC San Antonio||Recruiting|
|San Antonio, Texas, United States|
|Sub-Investigator: Peter Fox, PhD|
|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|