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

Rehabilitation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03439800
• Other study ID #: CEP-UFRN 2.057.658
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

No additional information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Kinematics
• Nervous System Diseases
• Parkinson Disease
• Parkinsonian Disorders
• Primary Parkinsonism
• Rehabilitation

Intervention

Other:
• Mental and Physical Practice
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.
• Physical Practice
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.

Locations

Country	Name	City	State
Brazil	Lorenna Santiago	Parnamirim, Rio Grande Do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity	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	Electroencephalographic activity	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
Secondary	Mobility	Performance in the Timed Up and Go Test	Change from Baseline Mobility at 1 day, 7 days and 30 days after training sessions
Secondary	Stride length	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