Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123084
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2005-07-20
Brief Title:
Efficacy of Voice Treatment for Parkinsons Disease
Sponsor:
University of Colorado Boulder
Organization:
University of Colorado Boulder
Study Overview
Official Title:
Efficacy of Voice Treatment for Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the research study is to determine the effects of two different kinds of speech treatment on certain behaviors in individuals with parkinsons disease These behaviors include speech voice related communication behaviors swallowing and body movement
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 HCUp 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 studySome 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 123 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 ENTCLINICAL 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 2-25 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
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 HCUp 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 studySome 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 123 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 ENTCLINICAL 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 2-25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DC001150 | NIH | None | httpsreporternihgovquickSearchR01DC001150 |