Mental Practice in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Mental Practice on the March and the Risk of Falls in People With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729454
• Other study ID #: CAAE 46155315.3.0000.5208
• Status: Completed
• Phase: N/A
• First received: March 26, 2016
• Last updated: September 27, 2016
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Introduction Although drug therapy is the mainstay of treatment for Parkinson's disease, the therapy also has its importance by means of exercises which maintains the muscular activity and preserve mobility. One of the techniques that has been used for physical therapy is the mental practice of the mental simulation of movement, aiming at learning or improvement of motor skills through the cortex areas of activation responsible for the movement of preparation before it is executed. In patients with Parkinson's disease motor anticipation this system is compromised, culminating in the march changes and increased risk of falls. Objective: To evaluate the effects of mental practice on physical therapy on the march and the risk of falls in people with Parkinson's disease. Method: The study is defined as a randomized clinical trial with systematic recruitment. Recruitment will be conducted at the Clinic of Neurology, Hospital das clinics Federal University of Pernambuco (Pro-Parkinson Project: Neurology) and the intervention will be held at the same hospital physiotherapy clinic. Both the control group and the trial will be subjected to 15 therapy sessions twice a week, lasting 40 minutes for physical therapy and 15 for mental practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Mental practice and physical therapy

• physical therapy

Locations

Country	Name	City	State
Brazil	Hospital Das Clinicas - Ufpe	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Gait Index test to evaluate gait and risk of falls	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	No
Primary	Timed up and go Test to evaluate risk of falls	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	two months	No
Primary	Walk Test of 10 meters to evaluate gait	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.	two months	No
Primary	history questionnaire falls to evaluate risk of falls	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?	two months	No