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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01131494
Other study ID # 249/2008
Secondary ID
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


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
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