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

October 8, 2024 updated by: Constanza San Martín, University of Valencia
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

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 Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • University of Valencia
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

The inclusion criteria are:

  1. Diagnosed with PD according to the United Kingdom Parkinson's Disease Society Brain Bank diagnostic scale
  2. Independent walk in a 10-meter corridor
  3. Normal cognitive state, determined by the Mini-Mental State Examination with a score >25
  4. Stable medication from the month before the start of the study until the t2 assessment.

Likewise, the exclusion criteria are:

  1. Additional neurological condition different from PD
  2. Disease or musculoskeletal acute alteration that limits mobility or balance
  3. Lower extremities asymmetries >1 cm
  4. Report pain on the Visual Analog Scale
  5. Suffer from blindness, deafness, or any other visual/hearing impairment or pathology that may influence the ability to understand instructions and carry them out
  6. Significant tremor that may interrupt the MI exercise
  7. To perform other physical therapies or sports during the trial or the two months before.

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: Motor imagery and gait training group

Gait 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.
Other: Physical rehabilitation of gait with motor imagery
Physical rehabilitation of gait is a type of non-invasive treatment that seeks to change the way of performing a task or motor function (in this case, gait) through movement modification and corrected repeated practice, taking into account the alterations, limitations and considerations related to the disease suffered by the person. In this intervention, in addition to physical exercise to correct gait, mental exercises will be included in which the patient visualizes himself performing the exercises that he will then develop with the body.
Other Names:
  • GAITimagery program
Active Comparator: Gait training group without motor imagery

Gait 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.
Other: Physical rehabilitation of gait without motor imagery
Physical rehabilitation of gait is a type of non-invasive treatment that seeks to change the way of performing a task or motor function (in this case, gait) through movement modification and corrected repeated practice, taking into account the alterations, limitations and considerations related to the disease suffered by the person. Motor imagery exercises are not included in this program.
Other Names:
  • Gait physiotherapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait velocity at the post-training time (primary time point)
Time Frame: 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).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride length
Time Frame: 6 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).
6 weeks
Cadence (steps/min)
Time Frame: 6 weeks
Number of steps executed in a time interval, its most commonly adopted unit being the step per minute.
6 weeks
Range of motion of lower limb joint (°)
Time Frame: 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).
6 weeks
Maximum ankle dorsiflexion during swing (°)
Time Frame: 6 weeks
Kinematic outcome; Maximum ankle dorsiflexion angle reached during the swing phase, expressed in degrees.
6 weeks
Maximum knee flexion during swing (°)
Time Frame: 6 weeks
Kinematic outcome; Maximum knee flexion angle reached during the swing phase, expressed in degrees.
6 weeks
Maximum hip extension during stance (°)
Time Frame: 6 weeks
Kinematic outcome; Maximum hip extension angle reached during the stance phase, expressed in degrees.
6 weeks
Maximum hip flexion during swing (°)
Time Frame: 6 weeks
Kinematic outcome; Maximum hip flexion angle reached during the swing phase, expressed in degrees.
6 weeks
Weight-acceptance Ground Reaction Force (Newton, N; Weight%)
Time Frame: 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.
6 weeks
Midstance Ground Reaction Force (Newton, N; Weight%)
Time Frame: 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.
6 weeks
Push-off Ground Reaction Force (Newton, N; Weight%)
Time Frame: 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.
6 weeks
Breaking Ground Reaction Force (Newton, N; Weight%)
Time Frame: 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.
6 weeks
Propulsion Ground Reaction Force (Newton, N; Weight%)
Time Frame: 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.
6 weeks
Freezing of gait
Time Frame: 6 weeks
Freezing of gait Questionnaire score
6 weeks
Gait speed variability
Time Frame: 6 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.
6 weeks
Gait qualitative performance with TMT
Time Frame: 6 weeks
Tinetti mobility test - Gait section score
6 weeks
Gait qualitative performance with DYPAGS
Time Frame: 6 weeks
Dynamic Parkinson Gait Scale score
6 weeks
Balance qualitative performance with the TMT
Time Frame: 6 weeks
Tinetti mobility test - Balance section score
6 weeks
Balance qualitative performance with the MiniBest
Time Frame: 6 weeks
MiniBest test score
6 weeks
Mobility
Time Frame: 6 weeks
Time taken to perform Timed-up and go test (s)
6 weeks
Maximum gait speed
Time Frame: 6 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).
6 weeks
Stance time
Time Frame: 6 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.
6 weeks
Step length
Time Frame: 6 weeks
The distance measured between one foot's heel contact and the other's heel contact. It is expressed in meters (m).
6 weeks
Swing time
Time Frame: 6 weeks
Time elapsed while the swing phase develops. It is expressed as a percentage according to the entire walking cycle and additionally in seconds.
6 weeks
Double support time
Time Frame: 6 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.
6 weeks
Activities of daily life
Time Frame: 6 weeks
Self-referred Quality of Life measured with the Schwab & England scale score.
6 weeks
Quality of Life perceived
Time Frame: 6 weeks
Self-referred quality of life measured with the Parkinson's Disease Questionnaire-39 score questionnaire.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Asociación Parkinson Valencia

Investigators

  • Principal Investigator: Constanza San Martín, PhD., Associate Lecturer professor at the Department of Physiotherapy

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.

General Publications

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 (Estimated)

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1557673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All measured and recorded data will be shared through the publications made and through their supplementary material.

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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