Trial Outcomes & Findings for Swallowing Training in Parkinson's Disease (NCT NCT01131494)
NCT ID: NCT01131494
Last Updated: 2011-11-08
Results Overview
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.
COMPLETED
NA
17 participants
five weeks
2011-11-08
Participant Flow
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.
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.
Participant milestones
| Measure |
Swallowing Exercise Group
One group made swallowing exercises for five weeks. This group was compared before and after the study.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Swallowing Exercise Group
One group made swallowing exercises for five weeks. This group was compared before and after the study.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Swallowing Training in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Swallowing Exercise Group
n=17 Participants
One group made swallowing exercises for five weeks. This group was compared before and after the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
60.12 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: five weeksBased 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.
Outcome measures
| Measure |
Pre-intervention Measure
n=15 Participants
Measurements of the group made before begin intervention.
|
Post-intervention Measure
n=15 Participants
Measurements of the group made after the intervention.
|
|---|---|---|
|
Oropharyngeal Swallowing Score
|
22.15 Scores on a scale
Standard Deviation 9.36
|
21.93 Scores on a scale
Standard Deviation 12.81
|
SECONDARY outcome
Timeframe: five weeksMeasured 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.
Outcome measures
| Measure |
Pre-intervention Measure
n=15 Participants
Measurements of the group made before begin intervention.
|
Post-intervention Measure
n=15 Participants
Measurements of the group made after the intervention.
|
|---|---|---|
|
Quality of Life
|
64.33 scores in a scale
Interval 40.05 to 79.8
|
70.58 scores in a scale
Interval 47.72 to 77.13
|
Adverse Events
Swallowing Exercise Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place