- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01131494
Swallowing Training in Parkinson's Disease
October 4, 2011 updated by: Natalie Argolo Pereira Ponte, Federal University of Bahia
Dysphagia Therapy for Parkinson's Disease: the Role of the Oral Motor Exercises
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 40110-170
- Federal University of Bahia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Swallowing exercises
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oropharyngeal Swallowing Score
Time Frame: five weeks
|
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.
|
five weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life
Time Frame: five weeks
|
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.
|
five weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ana Caline Nóbrega, PhD, Federal University of Bahia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
May 25, 2010
First Submitted That Met QC Criteria
May 26, 2010
First Posted (Estimate)
May 27, 2010
Study Record Updates
Last Update Posted (Estimate)
November 8, 2011
Last Update Submitted That Met QC Criteria
October 4, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurologic Manifestations
- Gastrointestinal Diseases
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Esophageal Diseases
- Laryngeal Diseases
- Disease
- Parkinson Disease
- Deglutition Disorders
- Voice Disorders
Other Study ID Numbers
- 249/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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