Parkinson DiseaseNCT02729454
Mental Practice in Parkinson's Disease
A study testing Mental practice and physical therapy and physical therapy in people with Parkinson Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mental practice and physical therapy and physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical diagnosis of idiopathic Parkinson's disease
- Male and female
- Stage 1-3 of the Hoehn and Yahr scale.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mental Practice on the March and the Risk of Falls in People With Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Being tested
- Mental practice and physical therapy, physical therapy
- 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 physical therapyOther
physical therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Exclusively physical therapy | Active comparator | 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. Receives: Other: physical therapy |
| Mental Practice And Physical Therapy | Experimental | 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. Receives: Other: Mental practice and physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two months
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
Measured: two months
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.
Measured: two months
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?
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LILIANE PEREIRA DA SILVA, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729454
- Sponsor's protocol ID
- CAAE 46155315.3.0000.5208
- Status last verified
- Sep 2016
- First submitted
- 26 Mar 2016
- Last updated
- 28 Sep 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 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Practice on the March and the Risk of Falls in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02729454
- Acronym / sponsor ID
- CAAE 46155315.3.0000.5208
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusively physical therapy | Active comparator | Other: physical therapyThe 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. |
| Mental Practice And Physical Therapy | Experimental | Other: Mental practice and physical therapyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinical diagnosis of idiopathic Parkinson's disease
- Male and female
- Stage 1-3 of the Hoehn and Yahr scale.
Key exclusion criteria (9 listed)
- 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
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 physical therapy | Other | Mental Practice And Physical Therapy |
| physical therapy | Other | Exclusively physical therapy |
Primary outcome
Dynamic Gait Index test to evaluate gait and risk of falls
Time frame: two months
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
Timed up and go Test to evaluate risk of falls
Time frame: two months
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
Walk Test of 10 meters to evaluate gait
Time frame: two months
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.
history questionnaire falls to evaluate risk of falls
Time frame: two months
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?
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 28 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental practice and physical therapy and physical therapy in people with Parkinson Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 3 inclusion and 9 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Dynamic Gait Index test to evaluate gait and risk of falls (time frame: two months). The study lists 4 primary outcomes in all. 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 28 Sep 2016.