Deglutition Disorders, Parkinson's Disease, Voice Disorders
Conditions
Keywords
Parkinson's disease, Dysphagia, Treatment
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).
Interventions
OTHERMotor 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.
Sponsors
Federal University of Bahia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Swallowing Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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. |
Countries
Brazil
Participant flow
Recruitment details
Consecutive patients from Movement Disorders Ambulatory of Federal University of Bahia in Brazil with idiopathic Parkinson disease (IPD) and complaint of dysphagia, from March 2009 to June 2010, were invited to participate.
Pre-assignment details
Patients with severe dysphagia who needed others interventions (for example: management of food consistency, alternative way of feeding) were excluded. During the study, subjects with absence in three sessions of exercises were excluded from the study and sent to Ambulatory of Speech and Deglutition Disorders at Federal University of Bahia.
Participants by arm
| Arm | Count |
|---|---|
| Swallowing Exercise Group One group made swallowing exercises for five weeks. This group was compared before and after the study. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Swallowing Exercise Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age Continuous | 60.12 years STANDARD_DEVIATION 12.34 |
| Region of Enrollment Brazil | 17 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: five weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-intervention Measure | Oropharyngeal Swallowing Score | 22.15 Scores on a scale | Standard Deviation 9.36 |
| Post-intervention Measure | Oropharyngeal Swallowing Score | 21.93 Scores on a scale | Standard Deviation 12.81 |
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.
Time frame: five weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-intervention Measure | Quality of Life | 64.33 scores in a scale |
| Post-intervention Measure | Quality of Life | 70.58 scores in a scale |