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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02738528
Other study ID # CAAE N°. 29242414.2.0000.5208
Secondary ID
Status Completed
Phase N/A
First received April 8, 2016
Last updated April 8, 2016
Start date September 2014
Est. completion date October 2015

Study information

Verified date April 2016
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 80 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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