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

Primary Purpose

Primary Parkinsonism, Rehabilitation, Kinematics

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mental and Physical Practice
Physical Practice
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Parkinsonism

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lorenna SantiagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mental and Physical Practice

Physical Practice

Arm Description

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.

Physical Practice: is the execution of the motor action.

Outcomes

Primary Outcome Measures

Velocity
Gait velocity in meters/second evaluated with Qualisys Motion Capture System

Secondary Outcome Measures

Electroencephalographic activity
Sharpness of the mental image evaluated by the Emotiv Epoc +
Mobility
Performance in the Timed Up and Go Test
Stride length
Stride length during gait of the most affected lower evaluated with Qualisys Motion Capture System

Full Information

First Posted
November 15, 2017
Last Updated
February 5, 2019
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03439800
Brief Title
Effects of Motor Imagery Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease
Official Title
Effects of Motor Imagery and Action Observation Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Parkinsonism, Rehabilitation, Kinematics, Gait Disorders, Neurologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mental and Physical Practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Practice
Arm Type
Active Comparator
Arm Description
Physical Practice: is the execution of the motor action.
Intervention Type
Other
Intervention Name(s)
Mental and Physical Practice
Intervention Description
Subjects will see a video of the typical gait and will attempt to analyze the sequence of the gait cycle. They will imagine themselves walking in the first-person perspective (kinesthetic) using the gait of the non-pathological pattern during 2 minutes. From the 1st to 4th session, the subjects will perform gait with corrections identified in previously in the video for 2 minutes. 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. From 9th to final training session: both mental and physical practice of the dual task gait.
Intervention Type
Other
Intervention Name(s)
Physical Practice
Intervention Description
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. 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. 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. From the 9th to the final training session, the subjects will do physical practice of the dual task gait.
Primary Outcome Measure Information:
Title
Velocity
Description
Gait velocity in meters/second evaluated with Qualisys Motion Capture System
Time Frame
Change from Baseline Velocity at 1 day, 7 days and 30 days after training sessions
Secondary Outcome Measure Information:
Title
Electroencephalographic activity
Description
Sharpness of the mental image evaluated by the Emotiv Epoc +
Time Frame
Change from Baseline Electroencephalographic activity at 1 day, 7 days and 30 days after training sessions
Title
Mobility
Description
Performance in the Timed Up and Go Test
Time Frame
Change from Baseline Mobility at 1 day, 7 days and 30 days after training sessions
Title
Stride length
Description
Stride length during gait of the most affected lower evaluated with Qualisys Motion Capture System
Time Frame
change from Baseline Stride length at 1 day, 7 days and 30 days after training sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lorenna Santiago
City
Parnamirim, Rio Grande Do Norte
ZIP/Postal Code
59148-520
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenna Santiago
Phone
+5584999029083
Ext
+5584999029083
Email
lorennamms@gmail.com
First Name & Middle Initial & Last Name & Degree
Raquel Lindquist
Phone
+5584981175502
Ext
+5584981175502
Email
raquellindquist@ufrnet.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
31706325
Citation
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.
Results Reference
derived

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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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