NCT02738528

Brief Summary

Parkinson's disease (PD) is characterized by dopaminergic neurons degeneration of the substantia nigra, in the midbrain, resulting in the presence of motor disorders, such as tremor, rigidity, bradykinesia, and postural instability. Researches have shown that mental rehearsal in learning motor skills through mental practice (MP), which associates the physical practice to somatosensory imagination to action, causes positive effects in several motor tasks, such as the speed of motion, muscle strength performance and accuracy. Thus, this study aims to report the effects of MP as a tooth brushing training strategy in people with Parkinson's disease. This project was approved by the Ethics Committee in Research with Human beings of UFPE and attempt to compare the presence of bacterial biofilm before and after 8 weeks of brushing through the mental practice training, based on O'Leary's index. The sample consisted of 35 people, divided into two groups: Intervention Group consists of 17 people with Parkinson's, in stages I to III of the disease, who underwent brushing orientation associated with PM, and the control group people without the disease, who received only orientation brushing. Then, the data were evaluated by factorial ANOVA 2x2 and post hoc Tukey test considering p \<0.05. It was observed that after the intervention was a significant improvement of the control dental biofilm.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

April 8, 2016

Last Update Submit

April 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dental biofilm

    Based on O'Leary's index, the calculation was made dividing the number of surfaces stained by the total number of scanned surfaces, multiplied by 100.

    8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Mental practice and brushing guidance in patients with Parkinson Disease

Other: Mental practice and brushing guidance in patients with Parkinson Disease

Control group

NO INTERVENTION

Brushing guidance in patients without Parkinson Disease

Interventions

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40 and 80 years;
  • Idiopathic PD Clinical Diagnostics according to the Bank of brain London;
  • Patients in stages I to III according to Hoehn and Yahr;
  • Satisfactory communicative and cognitive level checked by the Mini-Mental State Examination;
  • Subject to satisfactory clinical, lying in his home in the care of relatives;
  • Patients who possessed a sextant of the dental arch with teeth.
  • In the control group individuals without neurological disease were included: both sexes at ages similar to the group with PD, satisfactory health, active life, and natural teeth.

You may not qualify if:

  • Another neurological disease associated with PD;
  • Mioarticulares abnormalities in the upper limbs to prevent their use for independent brushing;
  • Use of orthotic / prosthetic hand;
  • Toothless in both dental arches.
  • In the control group were excluded individuals with mioarticulares abnormalities of the upper limbs; in use of orthotic / prosthetic hand; presenting any movement disorder in the upper limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD PRINCIPAL INVESTIGATOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 14, 2016

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 14, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share