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NCT Number: NCT04788693

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • 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.
  • To check the effect, in the short and medium-term, of a gait training program combined with MI in people diagnosed with PD.
  • To compare the effects of the gait and MI training program with the effects obtained through a gait rehabilitation program without MI exercises.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria are:

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

Likewise, the exclusion criteria are:

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

Treatment and study plan

Physical rehabilitation of gait with motor imagery

Other

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

Physical rehabilitation of gait without motor imagery

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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).

  12. 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.

  13. 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.

  14. 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).

  15. Maximum ankle dorsiflexion during swing (°)

    Time frame: 6 weeks

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

  16. Maximum knee flexion during swing (°)

    Time frame: 6 weeks

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

  17. Maximum hip extension during stance (°)

    Time frame: 6 weeks

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

  18. Maximum hip flexion during swing (°)

    Time frame: 6 weeks

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

  19. Activities of daily life

    Time frame: 6 weeks

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

  20. Quality of Life perceived

    Time frame: 6 weeks

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

  21. Freezing of gait

    Time frame: 6 weeks

    Freezing of gait Questionnaire score

  22. Gait qualitative performance with TMT

    Time frame: 6 weeks

    Tinetti mobility test - Gait section score

  23. Gait qualitative performance with DYPAGS

    Time frame: 6 weeks

    Dynamic Parkinson Gait Scale score

  24. Balance qualitative performance with the TMT

    Time frame: 6 weeks

    Tinetti mobility test - Balance section score

  25. Balance qualitative performance with the MiniBest

    Time frame: 6 weeks

    MiniBest test score

  26. Mobility

    Time frame: 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Constanza San Martín, PhD.

CONTACT

[email protected]

963864768

Luz Sánchez, PhD.

CONTACT

[email protected]

963983853

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Asociación Parkinson Valencia

Registry information

Acronym: GAITimagery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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