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Effects of Motor Imagery Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03439800
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte

Tracking Information
First Submitted Date  ICMJE November 15, 2017
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE February 15, 2018
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • 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 +
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Motor Imagery Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease
Official Title  ICMJE Effects of Motor Imagery and Action Observation Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease: Randomized Controlled Clinical Trial
Brief Summary 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.
Detailed Description No additional information.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Parkinsonism
  • Rehabilitation
  • Kinematics
  • Gait Disorders, Neurologic
Intervention  ICMJE
  • Other: Mental and Physical Practice
    1. Subjects will see a video of the typical gait and will attempt to analyze the sequence of the gait cycle.
    2. They will imagine themselves walking in the first-person perspective (kinesthetic) using the gait of the non-pathological pattern during 2 minutes.
    3. From the 1st to 4th session, the subjects will perform gait with corrections identified in previously in the video for 2 minutes.
    4. From 5th to 8th session: the subjects will do the protocol already described, however, the imagined gait will be in an environment with obstacles, also for 2 minutes. They will continue with the physical practice of the gait with obstacles.
    5. From 9th to final training session: both mental and physical practice of the dual task gait.
  • Other: Physical Practice
    1. Subjects will see a video about PD which does not mention physiotherapy treatments related to gait and they will explain their understanding about the theme.
    2. Then, the patients will make the physical gait protocol. Patients will be invited to perform the gait, in flat and firm ground with a length of 60 meters. The execution will be carried out for 10 minutes.
    3. From the 5th to 8th session, the subjects will do the physical practice of the gait with obstacles (which will be: going through 2 cones zigzag, going up and down 1 step, going through a narrow door, going up and down 1 ramp, going over 1 box of shoes, climbing a ramp, going down 1 step) for 2 minutes.
    4. From the 9th to the final training session, the subjects will do physical practice of the dual task gait.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Mental and Physical Practice
  • Active Comparator: Physical Practice
    Physical Practice: is the execution of the motor action.
    Intervention: Other: Physical Practice
Publications * Nascimento IAPDS, Santiago LMM, de Souza AA, Pegado CL, Ribeiro TS, Lindquist ARR. Effects of motor imagery training of Parkinson's disease: a protocol for a randomized clinical trial. Trials. 2019 Nov 9;20(1):626. doi: 10.1186/s13063-019-3694-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03439800
Other Study ID Numbers  ICMJE CEP-UFRN 2.057.658
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte
Study Sponsor  ICMJE Universidade Federal do Rio Grande do Norte
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal do Rio Grande do Norte
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP