Parkinson's DiseaseNCT02738528
MENTAL PRACTICE IN MOTOR LEARNING OF BRUSHING AND PARKINSON DISEASE
A study testing Mental practice and brushing guidance in patients with Parkinson Disease in people with Parkinson's Disease, run by Universidade Federal de Pernambuco.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Mental practice and brushing guidance in patients with Parkinson Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Parkinson's Disease
- Being tested
- Mental practice and brushing guidance in patients with Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental practice and brushing guidance in patients with Parkinson DiseaseOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Mental practice and brushing guidance in patients with Parkinson Disease Receives: Other: Mental practice and brushing guidance in patients with Parkinson Disease |
| Control group | No intervention | Brushing guidance in patients without Parkinson Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARLA CABRAL DOS SANTOS ACCIOLY LINS, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738528
- Sponsor's protocol ID
- CAAE N°. 29242414.2.0000.5208
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPLICATION OF MENTAL PRACTICE IN MOTOR LEARNING OF BRUSHING ON PEOPLE WITH PARKINSON
- ClinicalTrials.gov ID
- NCT02738528
- Acronym / sponsor ID
- CAAE N°. 29242414.2.0000.5208
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Mental practice and brushing guidance in patients with Parkinson DiseaseMental practice and brushing guidance in patients with Parkinson Disease |
| Control group | No intervention | –Brushing guidance in patients without Parkinson Disease |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental practice and brushing guidance in patients with Parkinson Disease | Other | Experimental Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mental practice and brushing guidance in patients with Parkinson Disease in people with Parkinson's Disease, run by Universidade Federal de Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental biofilm (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.