AzTrials
AzTrials

Dysphagia, OropharyngealNCT02973698

Benefit From the Chin Down Maneuver in the Swallowing Performance and Self-perception of Parkinson's Disease Patients

A study testing chin-down posture maneuver and Orientations about swallowing in people with Dysphagia, Oropharyngeal and Parkinson Disease, run by Hospital de Clinicas de Porto Alegre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Objective: To verify the effectiveness of chin-down posture maneuver in swallowing therapy for Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
chin-down posture maneuver and Orientations about swallowing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
Jun 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of Parkinson's disease and diagnosis of oropharyngeal dysphagia

Who cannot join

  • presenting language and hearing disorders, which could complicate the understanding of an intervention program, diagnosis of dementia or other neurological illnesses.

About this study

Official title: Effects of a Speech-Language Pathology Intervention on Individuals With Parkinson's Disease

Objective: To verify the effectiveness of chin-down posture maneuver in swallowing therapy for Parkinson's disease (PD).

Read the detailed description

Participants Participants were PD patients recruited from a Parkinson´s disease and Movement Disorders Clinic from Hospital de Clínicas de Porto Alegre (HCPA), a reference hospital, in the Rio Grande do Sul, Brazil. It was obtained from participants the written free and informed consent to participate in the research. This study was approved by the hospital central research ethics committee.

Inclusion and exclusion criteria Patient evaluation It was performed cognitive screening which consists of Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) in all patients before the intervention. It was also applied the instruments Parkinson Disease Questionnaire-39 (PDQ-39), translated to Portuguese, and the Beck Depression Inventory (BDI). These tests were applied to verify the influence of cognitive aspects, depression and quality of life in the therapeutic process.

To evaluate the intervention's effectiveness, an evaluation of swallowing was conducted in two moments (before and after intervention). Three kinds of assessments were performed: (1). Fiberoptic endoscopic evaluation of swallowing (FEES); (2) Clinical evaluation and (3) assessment of the quality of life related to swallowing (SWALQOL).

  • Fiberoptic endoscopic evaluation of swallowing (FEES): This objective examination of swallowing was performed according to the following protocol: First, it was tested the prior state of secretion in the nasopharyngeal structures, oropharynx, and laryngopharynx. Next, the individual received liquid consistency offered through a syringe, 3 and 5ml of water with edible blue food coloring. For the pasty consistency, 3 and 5ml of thickened water were provided through a syringe with edible blue food coloring. It was offered ¼- water and salt biscuits with good blue food coloring to assess the solid consistency. No anesthetic was used for the examination. The images were later analyzed by an otolaryngologist physician, experienced in the dysphagia area. It was observed the presence of thickening on the posterior laryngeal wall, tremor in structures (base of tongue and vallecula), early escape (characterized by the presence of food in the hypopharynx or larynx before the swallowing reflex was triggered), vallecular stasis in glossoepiglottic folds and pyriform sinus (characterized by accumulation of food after the third swallowing on the mentioned structures), penetration (characterized by the presence of food in the laryngeal vestibule), tracheal aspiration (characterized by food intake in the region located below the vocal folds, in the subglottic region and in the trachea, at any time of swallowing) and cough reflex. The alterations were classified as present or absent. The equipment used was the flexible nasopharyngoscope Maschida ENT-III, 3.2mm, with Xerônio Storz light source.
  • Clinical evaluation and Functional Oral Intake Scale (FOIS): clinical evaluation of swallowing was performed by a certified speech therapist, previously trained to apply the protocols. All the evaluations were conducted by the same professional. This assessment had the purpose of checking signs and symptoms of oropharyngeal dysphagia. It was used solid food consistency (half portion of bread) and liquid (100ml of water) evaluated by free demand. The analyzed signs and symptoms were: history of aspiration pneumonia; alert state; interaction attention/ability; awareness of the swallowing problem; awareness of secretion; ability to manipulate flows; postural control; fatigability; anatomy and oral, pharyngeal and laryngeal physiology; orofacial tonus; oral apraxia; orofacial sensitivity; gag pharyngeal contraction; saliva swallowing; cough and hawk; swallowing apraxia; oral residue; delayed swallowing reflex; reduction in laryngeal elevation; wet voice; and multiple swallowing. A total of 21 signs and symptoms were evaluated as present or absent. At the end of the objective and clinical evaluation, the intake of food was scored according to Functional Oral Intake Scale (FOIS). This scale scores the level of oral food intake of patients at specific levels, from 0 (restricted to alternative food pathway) to 7 (total oral intake with no restrictions), with the aim of monitoring the patients' evolution during the therapeutic process. A translated and validated version for Brazilian Portuguese was used.
  • The quality of Life in Swallowing Disorders: The questionnaire Quality of Life in Swallowing Disorders (SWAL-QOL) was applied, to verify the symptoms presented by the patients, as well as their influence on the quality of life. This instrument has Alpha Cronbach coefficient higher than 0.80, except in one domain. Thus, it presents excellent internal consistency and short-term reproducibility. It is a sensitive scale to differentiate oropharyngeal dysphagia degrees of severity. The version translated and validated for Brazilian Portuguese was used. All questionnaires were applied in a waiting room. The questions and possible answers were read by the researcher for all patients. The questionnaires application was performed individually, for each patient.

Intervention Individuals who agreed to participate in this study were allocated to one of the three interventions groups: (1) experimental group (patients performed the chin-down posture maneuver), (2) control group (PD individuals without any intervention) and (3) orientation group (PD participants that received swallowing orientations).

  1. Experimental group (EG) (chin-down posture maneuver group): patients in received an intervention program consisting of four weekly individual sessions of 30 minutes. In these sessions, it was performed the training of Chin-down postural maneuver with saliva and water. The participants were trained to perform the maneuver twice a day, swallowing saliva, and during meals, throughout the week, at home. The participants received a form, so they recorded the number of times they performed the maneuver at home. It allowed the control of adherence, being reinforced at each session the importance of adherence to treatment. Besides, the subjects received instructions regarding feeding. All the instructions, as well as the explanation about the maneuver, were submitted to the patients through a written document.
  2. Control group (CG) (PD individuals without any intervention): The participants of this group underwent evaluation of swallowing, and the same assessment was repeated after four weeks, without any intervention during that period.
  3. Orientations group (OG): the individuals participated in an intervention program which consisted of four individual sessions a week, with 30 minutes. In these sessions, the instructions about feeding were performed. The individuals received all the instructions on a written document. In the sessions, it was verified doubts about the guidelines and treatment adherence. In this group, it was not applied the Chin-down postural maneuver.

The EG and OG interventions were used by the same researcher, previously trained. After the end of the research, it was offered to the CG and OG individuals the same swallowing therapy performed to the GE.

Being tested
chin-down posture maneuver, Orientations about swallowing, Control
Medical subject headings
Deglutition Disorders, Parkinson Disease, Communication Disorders, Orientation, Spatial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chin-down posture maneuverOther

    it was performed the training of Chin-down postural maneuver with saliva and water. Besides, the subjects received instructions regarding feeding.

  • Orientations about swallowingOther

    The instructions about feeding were performed. The individuals received all the instructions on a written document.

  • ControlOther

    No intervention will do

Study groups in NCT02973698
Study groupRoleWhat they receive
chin-down posture maneuverOtherThe patients in received an intervention program consisting of four weekly individual sessions of 30 minutes. In these sessions, it was performed the training of Chin-down postural maneuver with saliva and water. The participants were trained to perform the maneuver twice a day, swallowing saliva, and during meals, throughout the week, at home. The participants received a form, so they recorded the number of times they performed the maneuver at home. It allowed the control of adherence, being reinforced at each session the importance of adherence to treatment. Besides, the subjects received instructions regarding feeding. All the instructions, as well as the explanation about the maneuver, were submitted to the patients through a written document.
Receives: Other: chin-down posture maneuver; Other: Orientations about swallowing
ControlOtherThe participants of this group underwent evaluation of swallowing, and the same assessment was repeated after four weeks, without any intervention during that period.
Receives: Other: Control
Orientations about swallowingOtherThe individuals participated in an intervention program which consisted of four individual sessions a week, with 30 minutes. In these sessions, the instructions about feeding were performed. The individuals received all the instructions on a written document. In the sessions, it was verified doubts about the guidelines and treatment adherence. In this group, it was not applied the Chin-down postural maneuver.
Receives: Other: Orientations about swallowing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical evaluation of swallowing

    This assessment had the purpose of checking signs and symptoms of oropharyngeal dysphagia. It was used solid food consistency (half portion of bread) and liquid (100ml of water) evaluated by free demand. A total of 21 signs and symptoms were evaluated as present or absent

    Measured: Four weeks

Secondary outcomes (2)
  1. Fiberoptic endoscopic evaluation of swallowing

    This objective examination of swallowing was performed according to the following protocol: First, it was tested the prior state of secretion in the nasopharyngeal structures, oropharynx, and laryngopharynx. Next, the individual received liquid consistency offered through a syringe, 3 and 5ml of water with edible blue food coloring. For the pasty consistency, 3 and 5ml of thickened water were provided through a syringe with edible blue food coloring. It was offered ¼- water and salt biscuits with good blue food coloring to assess the solid consistency.

    Measured: Four weeks

  2. The quality of Life in Swallowing Disorders

    The questionnaire Quality of Life in Swallowing Disorders (SWAL-QOL) was applied, to verify the symptoms presented by the patients, as well as their influence on the quality of life.

    Measured: Four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionJan 2015
  4. Study completionDec 2015

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973698
Sponsor's protocol ID
140263
Status last verified
Nov 2016
First submitted
22 Nov 2016
Last updated
28 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Ayres A, Jotz GP, Rieder CR, Olchik MR. Benefit from the Chin-Down Maneuver in the Swallowing Performance and Self-Perception of Parkinson's Disease Patients. Parkinsons Dis. 2017;2017:7460343. doi: 10.1155/2017/7460343. Epub 2017 Jan 19.

    PubMed 28203475

Questions about this trial

What is this clinical trial studying?

A study testing chin-down posture maneuver and Orientations about swallowing in people with Dysphagia, Oropharyngeal and Parkinson Disease, run by Hospital de Clinicas de Porto Alegre.

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 1 inclusion and 1 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Clinical evaluation of swallowing (time frame: Four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973698, which also lists 1 linked publication.

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 28 Nov 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in