- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02729454
Mental Practice in Parkinson's Disease
Effects of Mental Practice on the March and the Risk of Falls in People With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pernambuco
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Recife, Pernambuco, Brazil, 50670-901
- Hospital das Clinicas - UFPE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with clinical diagnosis of idiopathic Parkinson's disease
- Male and female
- Stage 1-3 of the Hoehn and Yahr scale.
Exclusion Criteria:
- Have other neurological diseases
- They have decompensated systemic diseases
- Musculoskeletal changes that prevent the achievement of movements
- With lowering of the cognitive level assessed using the Mini-Mental State Examination with cutoff point according to education
- With respiratory impairment
- With medical restrictions for performing exercises
- Do not get hold motor imagination during the application of Visual and Kinesthetic Imagery Questionnaire-10
- In physical therapy, occupational therapy service for 3 months or more;
- Patients with moderate to severe depression assessed by inventory Beck Depression Inventory
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Exclusively physical therapy
The patients will be submitted to 15 therapeutical sessions two times per week with length of 40 minutes for motor physiotherapy .
Each session of the motor physiotherapy will be constituted of exercises that include stretching (emphasizing the front of the torso), reinforcement (with emphasis in inferior members extensores); active exercises as transference (for example, to put into motion it bed or uprising of a chair), to reach and to grasp and training of balance and march.
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Experimental: Mental Practice And Physical Therapy
In the group submitted to the mental Practice the sessions will be individualized and occur in tranquil room after physical therapy (Same performed with the control group).
During the mental practice the patient will be guided to stand, where he will be requested initially to identify and to sequencer the necessary joints for the accomplishment of an only step, being they:flexion of the thigh and leg rights, extension of the right leg more dorsiflexed of the right foot; touch of the heel and discharge of weight of the right foot and inclined body to the front.
The sessions occur two times per week during 15 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dynamic Gait Index test to evaluate gait and risk of falls
Time Frame: two months
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It is an instrument of functional mobility assessment, the Dynamic Gait Index (DGI), aims to evaluate and document the patient's ability to modify the march in response to changing demands of certain tasks. DGI consists of eight tasks involving gait in different sensorial contexts, which include flat surface, changes in gait speed, horizontal and vertical movements of the head, go over and around obstacles; turn on your own body axis, up and down stairs. Each patients is assessed by means of an ordinal scale with 4 categories and scored according to his/her own performance in each task: 3 = normal gait, 2 = slight impairment, 1 = moderate impairment and 0 = severe impairment. Maximum scoring is 24 points, and a score of 19 points or less is able to predict a risk of falls. Praz |
two months
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Timed up and go Test to evaluate risk of falls
Time Frame: two months
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The Tine up and Go Test (TUG) is used to assess risk of falls.
To perform the test the patient will be instructed to sit with his back on an unsupported chair arms and the examiner will give the verbal command "go" in which the patient will get up and go a distance of three meters , returning and sitting in the same chair with your back supported.Shorter values than 10 seconds to perform the test indicate low risk of falls, values between 10 to 20 seconds indicate medium risk of falls and greater than 20 seconds represent high risk for falls
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two months
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Walk Test of 10 meters to evaluate gait
Time Frame: two months
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The walk test of 10 m is a tool used to evaluate the spatial and temporal attributes kinematic gait, as it will be evaluated the average speed of travel, number of steps and cadence.
For the test will be placed markers in position 2 and 8 m.
The patient will be instructed to walk at a comfortable pace from one extreme to another.
A physical therapist will use the stopwatch to determine how long it takes for the patient to go through the central 6 meters of the route.
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two months
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history questionnaire falls to evaluate risk of falls
Time Frame: two months
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The falls of history questionnaire seeks reports of falls occurred in the patient's daily life and contains the following questions: 1. Have you fallen or stumbled in the last 12 months, for any reason, even if it is not related to Parkinson's disease? 2. How many times have you fallen in the last 12 months (daily / weekly / monthly / etc)? 3. Are you afraid of falling?
If dropped, question to clarify, for each fall (or default): 4.
Where were you when he fell? 5. What were you doing or trying to do at the moment?
6.
What do you think caused the fall? 7. Did you lose consciousness before the fall?
8. What pattern can be identified in the fall?
9.
You showed balance and nearly fell last year?
10.
How often have you had balance and nearly fell last year?
In case of almost fall, are asked to clarify the pattern: 11.
What kinds of things do you usually do when out of balance and almost fall?
12.
Why do you think that you almost fall?
13.
How do you avoid the drop this time?
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two months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 46155315.3.0000.5208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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