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Effects of Gait Rehabilitation With Motor Imagery in People With Parkinson's Disease

Not Applicable
Not yet recruiting
Conditions
Parkinson Disease
Interventions
Other: Physical rehabilitation of gait with motor imagery
Other: Physical rehabilitation of gait without motor imagery
Registration Number
NCT04788693
Lead Sponsor
University of Valencia
Brief Summary

This study aims to determine whether gait physiotherapy combined with motor imagery exercises has a superior effect than gait physiotherapy without motor imagery in people with Parkinson's disease. To do this, a six-week training program will be carried out twice a week, where walking exercises and motor imaging will be performed in the experimental group while walking exercises only, will be conducted in the control group. Motor imagery exercises consist of developing a mental exercise by which an individual rehearses or simulates a given action. We hypothesize that participants who perform motor imagery exercises have better results than participants who train without imagery exercises. To analyze the effect of the programs will be assess the gait, the functionality in activities of daily living, the motor capacity, and the perception of the quality of life of the participants.

Detailed Description

Background:

Motor imagery (MI) is a novel technique in neurorehabilitation. Current evidence supports the ability of people diagnosed with Parkinson's disease (PD) to carry out this technique. However, the trials that assess its effectiveness in this pathology are scarce. In some physical rehabilitation programs, MI is introduced to conventional treatment or, MI can be combined with observation of images or neurofeedback. At present, the effect of this technique has been studied in highly heterogeneous variables, including both motor and cognitive abilities or performance of activities of daily living. The evidence seems to indicate that the introduction of MI to conventional treatment, with an adequate dose, may induce greater benefits over people with PD in early stages (I-III on the Hoehn and Yahr scale), especially in daily actions and movements functional such as gait, regardless of medication. However, the small sample size of the trials and the use of non-validated scales and non-objective tests, make it necessary that the results be viewed with caution. On the other hand, the cost-benefit ratio of the therapy, its benefits and its easy application are significant factors to take into account when adding MI to physiotherapy treatment in people with PD.

General objective: To determine whether gait training combined with MI exercises has a superior effect on gait, functionality in activities of daily living, motor capacity, and the perception of the quality of life in people with PD, which gait training without MI.

Specific objectives:

1. To study the validity of the instrumental technique available for the evaluation of gait and the intra- and inter-rater reliability with the same tool in healthy subjects.

2. To check the effect, in the short and medium-term, of a gait training program combined with MI in people diagnosed with PD.

3. To compare the effects of the gait and MI training program with the effects obtained through a gait rehabilitation program without MI exercises.

4. To contrast the gait pattern of people with PD before and after undergoing a rehabilitation program with MI, with that of healthy older people of the same age, sex, and height.

5. To observe the differences in the biomechanics of gait between the hemibody most affected by the signs of PD and the hemibody with less clinical alteration, before and after performing a gait training program combined with MI exercises.

Materials and Method:

The evaluation session will be carried out three times: before the treatment, at the end of the intervention, and 8-weeks after the intervention has finished. In each evaluation session, a clinical and biomechanical measurement will be carried out. The biomechanical evaluation will be done using 7 inertial sensors in a 10-meter walk corridor. The inertial sensor or inertial measurement unit (IMU) is made up of three different sensors: gyroscope, accelerometer, and magnetometer, capable of collecting information on the turns, linear acceleration, and magnetic north with respect to the earth's magnetic field. The part of the clinical evaluation includes the assessment of the functionality in the activities of daily living, the motor capacity, and the perception of the quality of life through different questionnaires and assessment scales.

Intervention:

Both, the experimental and control groups of this study, will perform an identical gait physiotherapy program, however, motor imagery exercises will be included in the experimental group.

The gait exercises are aimed at improving specific gait characteristics, so they will include:

* Exercises for length stride: walk with visual cues on the ground to reach a certain stride length, walk with horizontal poles at a height of 2 cm, walk over steps, treadmill walk.

* Exercises for Cadence training using a metronome.

* Exercises for gait velocity training by combining the visual and auditory feedback provided in previous exercises and on the treadmill

* Exercises for kinematic milestones during the stance and oscillation phase of gait through the mobility of the ankle, knee, and hip joints.

The motor imagery exercises will be performed in supine position on a stretcher, before each gait exercise. The instructions will be administered through the physiotherapy voice. The participant with closed eyes imagines himself performing the gait task while the general guidelines that guide the cognitive process are given. The instructions describe how the person is from the starting position and the different body movements that he must pay attention to during the imagining process. Through the instructions, the participant creates an image of himself and perceives the kinesthesia while performing the exercise. The duration of each motor imagery exercise is 8 minutes.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
74
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Motor imagery and gait training groupPhysical rehabilitation of gait with motor imageryGait training twice a week for six weeks. Each rehabilitation session is composed of an initial 5 minutes of warm-up exercises (general mobility, coordination, strength, flexibility, balance, and breathing), followed by 45 minutes of gait training with motor imagery exercises and a final 10 minutes of muscle stretching. In the central 45 minutes of the session, exercises will be developed to improve objective characteristics of the gait-related to spatiotemporal and kinematic parameters. Objective and subjective feedback will be used for each exercise (cues). In an interspersed way, motor imagery exercises will be carried out where participants must rehearse or simulate mentally each gait exercise that will be developed in the session.
Gait training group without motor imageryPhysical rehabilitation of gait without motor imageryGait training twice a week for six weeks. Each rehabilitation session is composed of an initial 5 minutes of warm-up exercises (general mobility, coordination, strength, flexibility, balance, and breathing), followed by 45 minutes of gait training with motor imagery exercises and a final 10 minutes of muscle stretching. In the central 45 minutes of the session, exercises will be developed to improve objective characteristics of the gait-related to spatiotemporal and kinematic parameters. Objective and subjective feedback will be used for each exercise (cues). In the periods that the experimental group performs the motor imagery exercises, the control group will take breaks.
Primary Outcome Measures
NameTimeMethod
Gait velocity at the post-training time (primary time point)6 weeks

Distance traveled by the body per unit of time at self-selected or comfortable speed, in the direction considered. It is expressed in meters per second (m / s).

Secondary Outcome Measures
NameTimeMethod
Gait speed variability6 weeks

It is calculated through the coefficient of variation (\[standard deviation/mean\] × 100) of gait velocity. Indicates how stable or repeatable the participants are when walking.

Maximum gait speed6 weeks

Distance traveled by the body per unit of time at the maximum possible speed, in the direction considered. It is expressed in meters per second (m/s).

Stance time6 weeks

Time elapsed while the support or stance phase of the gait cycle is developed. It is expressed as a percentage of the total walking cycle and additionally in seconds.

Weight-acceptance Ground Reaction Force (Newton, N; Weight%)6 weeks

Kinetic outcome; First force peak of vertical vector of the ground reaction forces during the stance phase of the gait cycle, which corresponds to the maximum reception of weight on the foot that initiates the gait cycle.

Midstance Ground Reaction Force (Newton, N; Weight%)6 weeks

Kinetic outcome; Lowest force point of the valley located between both maximum force peaks of the vertical vector of the ground reaction forces, which corresponds to the swing of the opposite leg during the gait cycle.

Push-off Ground Reaction Force (Newton, N; Weight%)6 weeks

Kinetic outcome; Second and last force peak of the vertical vector of the ground reaction forces during the stance phase of the gait cycle, which corresponds to the beginning of takeoff of the foot during the last part of the stance phase.

Breaking Ground Reaction Force (Newton, N; Weight%)6 weeks

Kinetic outcome; First maximum force peak of the antero-posterior vector of the ground reaction forces during the gait cycle that corresponds to the braking of the foot on the ground.

Propulsion Ground Reaction Force (Newton, N; Weight%)6 weeks

Kinetic outcome; Second maximum force peak of the antero-posterior vector of the ground reaction forces during the gait cycle that corresponds to the propulsion of the foot on the ground at the end of the stance phase.

Cadence (steps/min)6 weeks

Number of steps executed in a time interval, its most commonly adopted unit being the step per minute.

Stride length6 weeks

Distance measured between two consecutive supports points of the same foot; the heel strike is the reference used. It is expressed in meters (m).

Step length6 weeks

The distance measured between one foot's heel contact and the other's heel contact. It is expressed in meters (m).

Swing time6 weeks

Time elapsed while the swing phase develops. It is expressed as a percentage according to the entire walking cycle and additionally in seconds.

Double support time6 weeks

Time that both feet are in contact with the ground during the gait cycle. It is expressed in seconds (s) and also as a percentage (%) of the total gait cycle.

Range of motion of lower limb joint (°)6 weeks

Kinematic outcome that represents the range of motion in the sagittal plane of the hip, knee, and ankle joints performed during the gait cycle. These parameters will be specified for each limb (right and left).

Maximum ankle dorsiflexion during swing (°)6 weeks

Kinematic outcome; Maximum ankle dorsiflexion angle reached during the swing phase, expressed in degrees.

Maximum knee flexion during swing (°)6 weeks

Kinematic outcome; Maximum knee flexion angle reached during the swing phase, expressed in degrees.

Maximum hip extension during stance (°)6 weeks

Kinematic outcome; Maximum hip extension angle reached during the stance phase, expressed in degrees.

Maximum hip flexion during swing (°)6 weeks

Kinematic outcome; Maximum hip flexion angle reached during the swing phase, expressed in degrees.

Activities of daily life6 weeks

Self-referred Quality of Life measured with the Schwab \& England scale score.

Quality of Life perceived6 weeks

Self-referred quality of life measured with the Parkinson's Disease Questionnaire-39 score questionnaire.

Freezing of gait6 weeks

Freezing of gait Questionnaire score

Gait qualitative performance with TMT6 weeks

Tinetti mobility test - Gait section score

Gait qualitative performance with DYPAGS6 weeks

Dynamic Parkinson Gait Scale score

Balance qualitative performance with the TMT6 weeks

Tinetti mobility test - Balance section score

Balance qualitative performance with the MiniBest6 weeks

MiniBest test score

Mobility6 weeks

Time taken to perform Timed-up and go test (s)

Trial Locations

Locations (1)

University of Valencia

🇪🇸

Valencia, Spain

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