An interventional study of Voice/Respiration Treatment and Speech/Articulation Treatment in Parkinson's Disease, Dysphagia and Dysarthria, sponsored by University of Colorado, Boulder. Completed at 2 sites in United States. Open to participants aged 45 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by University of Colorado, Boulder · Not applicable, Interventional, and Treatment
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.
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
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 620 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Colorado, Boulder is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
4 Days a week for 4 weeks with focus on high intensity voice exercises
Behavioral: Voice/Respiration Treatment
4 days a week for 4 weeks with focus on high intensity articulation tasks
Behavioral: Speech/Articulation Treatment
Subjects do not receive therapy during experimental phases, and will be offered therapy at the end of the study enrollment period.
Subjects are without Parkinson disease and will not receive therapy.
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort exercises focusing on increased loudness and good voice quality.
Also known as: LSVT LOUD
Therapy is 4 1-hour sessions per week for 4 weeks. Tasks include high-effort articulation exercises to promote more enunciated speech.
Also known as: LSVT ARTIC
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
The record gives a start of Mar 2002, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University of Colorado, Boulder