NCT02973698

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

November 22, 2016

Last Update Submit

November 25, 2016

Conditions

Outcome Measures

Primary Outcomes (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

    Four weeks

Secondary Outcomes (2)

  • Fiberoptic endoscopic evaluation of swallowing

    Four weeks

  • The quality of Life in Swallowing Disorders

    Four weeks

Study Arms (3)

chin-down posture maneuver

OTHER

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.

Other: chin-down posture maneuverOther: Orientations about swallowing

Control

OTHER

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

Other: Control

Orientations about swallowing

OTHER

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.

Other: Orientations about swallowing

Interventions

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

chin-down posture maneuver

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

Orientations about swallowingchin-down posture maneuver
ControlOTHER

No intervention will do

Control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Deglutition DisordersParkinson DiseaseCommunication DisordersOrientation, Spatial

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersSpatial BehaviorBehavior

Study Officials

  • Maira Olchik

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

November 28, 2016

Record last verified: 2016-11