Swallowing Training in Parkinson`s Disease

Parkinson's Disease Clinical Trial

Official title:

Dysphagia Therapy for Parkinson`s Disease: the Role of the Oral Motor Exercises

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131494
• Other study ID #: 249/2008
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: October 4, 2011
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Disease
• Parkinson Disease
• Parkinson's Disease
• Voice Disorders

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Bahia	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	five weeks	No
Secondary	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.	five weeks	No