- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02738528
MENTAL PRACTICE IN MOTOR LEARNING OF BRUSHING AND PARKINSON DISEASE
April 8, 2016 updated by: CARLA CABRAL DOS SANTOS ACCIOLY LINS, Universidade Federal de Pernambuco
APPLICATION OF MENTAL PRACTICE IN MOTOR LEARNING OF BRUSHING ON PEOPLE WITH PARKINSON
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Mental practice and brushing guidance in patients with Parkinson Disease
|
|
|
No Intervention: Control group
Brushing guidance in patients without Parkinson Disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental biofilm
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
April 8, 2016
First Submitted That Met QC Criteria
April 8, 2016
First Posted (Estimate)
April 14, 2016
Study Record Updates
Last Update Posted (Estimate)
April 14, 2016
Last Update Submitted That Met QC Criteria
April 8, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE N°. 29242414.2.0000.5208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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