Parkinson's DiseaseNCT01131494
Swallowing Training in Parkinson's Disease
A study testing Motor exercises for swallowing, breathing and phonation in people with Parkinson's Disease and Deglutition Disorders, run by Federal University of Bahia at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Deglutition Disorders, Voice Disorders
- What is being tested?
- Motor exercises for swallowing, breathing and phonation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease
- Complaint of dysphagia
Who cannot join
- Hoehn and Yahr stage 5
- Other neurological conditions
- Therapy for swallowing in the last 3 months
- Cognitive disorders
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dysphagia Therapy for Parkinson's Disease: the Role of the Oral Motor Exercises
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).
- Conditions
- Parkinson's Disease, Deglutition Disorders, Voice Disorders
- Being tested
- Motor exercises for swallowing, breathing and phonation
- Keywords
- Parkinson's disease, Dysphagia, Treatment
- Medical subject headings
- Parkinson Disease, Deglutition Disorders, Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor exercises for swallowing, breathing and phonationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Swallowing exercises | Experimental | Not described Receives: Other: Motor exercises for swallowing, breathing and phonation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: five weeks
Secondary outcomes (1)
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.
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMar 2009
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Argolo Pereira Ponte, Federal University of Bahia
- Investigators
- Ana Caline Nóbrega, PhD, Study chair, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131494
- Sponsor's protocol ID
- 249/2008
- Status last verified
- Oct 2011
- First submitted
- 25 May 2010
- Last updated
- 8 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia Therapy for Parkinson's Disease: the Role of the Oral Motor Exercises
- ClinicalTrials.gov ID
- NCT01131494
- Acronym / sponsor ID
- 249/2008
- Conditions
- Parkinson's Disease, Deglutition Disorders, Voice Disorders
- Keywords
- Parkinson's disease, Dysphagia, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Posted 8 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swallowing exercises | Experimental | Other: Motor exercises for swallowing, breathing and phonation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson disease
- Complaint of dysphagia
Key exclusion criteria (5 listed)
- Hoehn and Yahr stage 5
- Other neurological conditions
- Therapy for swallowing in the last 3 months
- Cognitive disorders
- Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor exercises for swallowing, breathing and phonationThis 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. | Other | Swallowing exercises |
Primary outcome
Oropharyngeal Swallowing Score
Time frame: 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.
1 secondary outcome
Quality of Life
Time frame: five weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Caline Nóbrega, PhD study chair
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor exercises for swallowing, breathing and phonation in people with Parkinson's Disease and Deglutition Disorders, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal Swallowing Score (time frame: five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.