Swallowing Training in Parkinson`s Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natalie Argolo Pereira Ponte, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01131494
First received: May 25, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention
Parkinson's Disease
Deglutition Disorders
Voice Disorders
Other: Motor exercises for swallowing, breathing and phonation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dysphagia Therapy for Parkinson`s Disease: the Role of the Oral Motor Exercises

Resource links provided by NLM:


Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • Oropharyngeal Swallowing Score [ Time Frame: five weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: five weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Swallowing exercises Other: Motor exercises for swallowing, breathing and phonation
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01131494

Locations
Brazil
Federal University of Bahia
Salvador, Bahia, Brazil, 40110-170
Sponsors and Collaborators
Federal University of Bahia
Investigators
Study Chair: Ana Caline Nóbrega, PhD Federal University of Bahia
  More Information

No publications provided

Responsible Party: Natalie Argolo Pereira Ponte, PhD Student, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT01131494     History of Changes
Other Study ID Numbers: 249/2008
Study First Received: May 25, 2010
Results First Received: May 5, 2011
Last Updated: October 4, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Federal University of Bahia:
Parkinson's disease
Dysphagia
Treatment

Additional relevant MeSH terms:
Parkinson Disease
Disease
Deglutition Disorders
Voice Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014