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

Primary Purpose

Dysphagia, Oropharyngeal, Parkinson Disease, Speech Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
chin-down posture maneuver
Orientations about swallowing
Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia, Oropharyngeal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    chin-down posture maneuver

    Control

    Orientations about swallowing

    Arm Description

    The 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.

    The participants of this group underwent evaluation of swallowing, and the same assessment was repeated after four weeks, without any intervention during that period.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    November 22, 2016
    Last Updated
    November 25, 2016
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02973698
    Brief Title
    Benefit From the Chin Down Maneuver in the Swallowing Performance and Self-perception of Parkinson's Disease Patients
    Official Title
    Effects of a Speech-Language Pathology Intervention on Individuals With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia, Oropharyngeal, Parkinson Disease, Speech Therapy, Orientation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    chin-down posture maneuver
    Arm Type
    Other
    Arm Description
    The 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.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    The participants of this group underwent evaluation of swallowing, and the same assessment was repeated after four weeks, without any intervention during that period.
    Arm Title
    Orientations about swallowing
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    chin-down posture maneuver
    Intervention Description
    it was performed the training of Chin-down postural maneuver with saliva and water. Besides, the subjects received instructions regarding feeding.
    Intervention Type
    Other
    Intervention Name(s)
    Orientations about swallowing
    Intervention Description
    The instructions about feeding were performed. The individuals received all the instructions on a written document.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    No intervention will do
    Primary Outcome Measure Information:
    Title
    Clinical evaluation of swallowing
    Description
    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
    Time Frame
    Four weeks
    Secondary Outcome Measure Information:
    Title
    Fiberoptic endoscopic evaluation of swallowing
    Description
    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.
    Time Frame
    Four weeks
    Title
    The quality of Life in Swallowing Disorders
    Description
    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.
    Time Frame
    Four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of Parkinson's disease and diagnosis of oropharyngeal dysphagia Exclusion Criteria: presenting language and hearing disorders, which could complicate the understanding of an intervention program, diagnosis of dementia or other neurological illnesses.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maira Olchik
    Organizational Affiliation
    Hospital de Clínicas de Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28203475
    Citation
    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.
    Results Reference
    derived

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