Swallowing Training in Parkinson`s Disease
This study has been completed.
Sponsor:
Federal University of Bahia
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
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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2010 | ||||
| Last Updated Date | October 4, 2011 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Swallowing dynamics [ Time Frame: six weeks ] [ Designated as safety issue: Yes ] Assessments with modified barium swallow |
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| Change History | Complete list of historical versions of study NCT01131494 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Swallowing Training in Parkinson`s Disease | ||||
| Official Title ICMJE | Dysphagia Therapy for Parkinson`s Disease: the Role of the Oral Motor Exercises | ||||
| 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). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: Swallowing exercises
Intervention: Other: Motor exercises for swallowing, breathing and phonation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 17 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01131494 | ||||
| Other Study ID Numbers ICMJE | 249/2008 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Natalie Argolo Pereira Ponte, Federal University of Bahia | ||||
| Study Sponsor ICMJE | Federal University of Bahia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Federal University of Bahia | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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