- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439800
Effects of Motor Imagery Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease
February 5, 2019 updated by: Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte
Effects of Motor Imagery and Action Observation Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease: Randomized Controlled Clinical Trial
INTRODUCTION: Mental practice (MP) and action observation (AO) are characterized as cognitive strategies that contribute to motor planning and learning in diverse populations.
Individuals with Parkinson's Disease (PD) are recent targets, since, with disease progression, they need external strategies to aid in motor organization.
However, there is still no evidence of the efficacy of MP and AO in the gait of PD.
OBJECTIVES: To compare the effects of physical practice preceded by MP and AO on gait performance in individuals with Idiopathic PD (IPD).
METHODS: A controlled, randomized, single-blind clinical trial with 66 individuals with IPD, aged between 50 and 75 years, without cognitive deficit and in the moderate phase of the disease will be performed.
For the inclusion and characterization of the sample, the following instruments / equipment will be used: (1) Identification form (sociodemographic, clinical and anthropometric aspects); (2) Mini Mental State Examination and Montreal Cognitive Assessment (cognitive level); (3) Hoehn and Yahr Scale (level of physical disability); (4) Revised Movement Imagery Questionnaire (sharpness of the mental image); (5) Qualisys Motion Capture Systems® (gait kinematics); (6) Emotiv Epoc + (electroencephalographic activity); (7) Unified Parkinson's Disease Rating Scale - UPDRS (motor function and activities of daily living); (8) Timed Up and Go Test - TUG Test (mobility); and (9) Parkinson's Disease Questionnaire - PDQ-39 (quality of life).Participants included will be randomly assigned to two groups: experimental (n = 33), who will participate in MP + AO and physical gait practice; and control group (n = 33), who will participate only in the physical practice of gait.
Both groups will be submitted to 12 training sessions (3x / week, for 4 weeks) and will be reevaluated 10 minutes, 7 days and 30 days after the last training session with respect to items (4), (5), (6) and (8) of the evaluation.
Primary outcomes will be velocity, stride length and range of motion of the hip and the secondary ones will be sharpness of the mental image, electroencephalographic activity and performance in the TUG Test.
The normality in the data distribution will be verified through the Shapiro-Wilk test.
The "t" test and the Mann-Whitney test will be used to verify the homogeneity of the groups in the baseline.
A repeated measures ANOVA will verify the interaction between the groups at the moments observed.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
No additional information.
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Parnamirim, Rio Grande Do Norte, Brazil, 59148-520
- Recruiting
- Lorenna Santiago
-
Contact:
- Lorenna Santiago
- Phone Number: +5584999029083 +5584999029083
- Email: lorennamms@gmail.com
-
Contact:
- Raquel Lindquist
- Phone Number: +5584981175502 +5584981175502
- Email: raquellindquist@ufrnet.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of PD according to the report of a neurologist;
- Age between 50 and 75 years;
- In the moderate stage of the disease (between stages 2 and 3 of the Hoehn and Yahr Scale);
- Use of antiparkinsonian medication;
- Do not present cognitive deficits, according to the Mini Mental State Examination - MMSE. The cutoff point will be defined considering the individual's schooling (Illiterates: 18; With school instruction: 24);
- Ability to imagine motor acts in kinesthetic mode (according to the Revised Movement Imagery Questionnaire - MIQ-R). The cut-off point will be 20 for the kinesthetic modality, indicating that it is at least "a little easy to feel" the kinesthetically imagined movement;
- Have not undergone stereotaxic surgery.
Exclusion Criteria:
- Individuals with other associated neurological diseases;
- Individuals with musculoskeletal disorders, not related to the disease, but that impair gait;
- Individuals with hemodynamic instability before or during training;
- Individuals with uncorrected visual or auditory changes;
- Individuals who do not understand some stage of the training protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mental and Physical Practice
Action observation: is defined as the observation of the motor action, in this study, through a video. Mental Practice: is defined as motor imagery training with the aim of improving the engine performance. Is the imagination of a motor action without its physical implementation. Physical Practice: is the execution of the motor action. |
|
|
Active Comparator: Physical Practice
Physical Practice: is the execution of the motor action.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Velocity
Time Frame: Change from Baseline Velocity at 1 day, 7 days and 30 days after training sessions
|
Gait velocity in meters/second evaluated with Qualisys Motion Capture System
|
Change from Baseline Velocity at 1 day, 7 days and 30 days after training sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electroencephalographic activity
Time Frame: Change from Baseline Electroencephalographic activity at 1 day, 7 days and 30 days after training sessions
|
Sharpness of the mental image evaluated by the Emotiv Epoc +
|
Change from Baseline Electroencephalographic activity at 1 day, 7 days and 30 days after training sessions
|
|
Mobility
Time Frame: Change from Baseline Mobility at 1 day, 7 days and 30 days after training sessions
|
Performance in the Timed Up and Go Test
|
Change from Baseline Mobility at 1 day, 7 days and 30 days after training sessions
|
|
Stride length
Time Frame: change from Baseline Stride length at 1 day, 7 days and 30 days after training sessions
|
Stride length during gait of the most affected lower evaluated with Qualisys Motion Capture System
|
change from Baseline Stride length at 1 day, 7 days and 30 days after training sessions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2018
Primary Completion (Anticipated)
August 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
February 13, 2018
First Posted (Actual)
February 20, 2018
Study Record Updates
Last Update Posted (Actual)
February 6, 2019
Last Update Submitted That Met QC Criteria
February 5, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP-UFRN 2.057.658
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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