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Swallowing Training in Parkinson's Disease

Primary Purpose

Parkinson's Disease, Deglutition Disorders, Voice Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motor exercises for swallowing, breathing and phonation
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Dysphagia, Treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Parkinson disease
  • Complaint of dysphagia

Exclusion Criteria:

  • Hoehn and Yahr stage 5
  • Other neurological conditions
  • Therapy for swallowing in the last 3 months
  • Cognitive disorders
  • Psychiatric disorders

Sites / Locations

  • Federal University of Bahia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Swallowing exercises

Arm Description

Outcomes

Primary Outcome Measures

Oropharyngeal Swallowing Score
Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.

Secondary Outcome Measures

Quality of Life
Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.

Full Information

First Posted
May 25, 2010
Last Updated
October 4, 2011
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT01131494
Brief Title
Swallowing Training in Parkinson's Disease
Official Title
Dysphagia Therapy for Parkinson's Disease: the Role of the Oral Motor Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and sensory abnormalities, and incoordination between swallowing and breathing. Despite harming as respiratory infections and increased risk of death, treatment of this condition remains uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal exercises for five weeks and will be evaluated before and after intervention by swallowing videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Deglutition Disorders, Voice Disorders
Keywords
Parkinson's disease, Dysphagia, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Swallowing exercises
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Motor exercises for swallowing, breathing and phonation
Intervention Description
This exercises aimed to increase strength and range of motion of mouth, larynx and pharynx structures. All patients made sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side. Patients underwent oral motor exercises twice a day, five days a week, for five weeks.
Primary Outcome Measure Information:
Title
Oropharyngeal Swallowing Score
Description
Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.
Time Frame
five weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.
Time Frame
five weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Parkinson disease Complaint of dysphagia Exclusion Criteria: Hoehn and Yahr stage 5 Other neurological conditions Therapy for swallowing in the last 3 months Cognitive disorders Psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Caline Nóbrega, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110-170
Country
Brazil

12. IPD Sharing Statement

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Swallowing Training in Parkinson's Disease

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