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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04788693
Acronym
GAITimagery
Enrollment
74
Registered
2021-03-09
Start date
2025-09-30
Completion date
2026-12-31
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Gait rehabilitation, Motor imagery, Biomechanics of gait, Parkinson's disease

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.

Interventions

OTHERPhysical 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.

OTHERPhysical 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.

Sponsors

Asociación Parkinson Valencia
CollaboratorOTHER
University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

To ensure masking, the raters physiotherapist, and data analysis researcher, will be blinded to the participant's allocation. Although participants and treating physiotherapists cannot be totally blinded to the intervention performed, the hypothesis and objectives of the study will be hidden from them. At the same time, all participants will be instructed not to disclose information regarding their intervention to the raters' physiotherapists.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait velocity at the post-training time (primary time point)6 weeksDistance 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

MeasureTime frameDescription
Maximum gait speed6 weeksDistance 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 weeksTime 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 weeksKinetic 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 weeksKinetic 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 weeksKinetic 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 weeksKinetic 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 weeksKinetic 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 weeksNumber of steps executed in a time interval, its most commonly adopted unit being the step per minute.
Stride length6 weeksDistance 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 weeksThe distance measured between one foot's heel contact and the other's heel contact. It is expressed in meters (m).
Swing time6 weeksTime 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 weeksTime 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.
Gait speed variability6 weeksIt 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 ankle dorsiflexion during swing (°)6 weeksKinematic outcome; Maximum ankle dorsiflexion angle reached during the swing phase, expressed in degrees.
Maximum knee flexion during swing (°)6 weeksKinematic outcome; Maximum knee flexion angle reached during the swing phase, expressed in degrees.
Maximum hip extension during stance (°)6 weeksKinematic outcome; Maximum hip extension angle reached during the stance phase, expressed in degrees.
Maximum hip flexion during swing (°)6 weeksKinematic outcome; Maximum hip flexion angle reached during the swing phase, expressed in degrees.
Activities of daily life6 weeksSelf-referred Quality of Life measured with the Schwab & England scale score.
Quality of Life perceived6 weeksSelf-referred quality of life measured with the Parkinson's Disease Questionnaire-39 score questionnaire.
Freezing of gait6 weeksFreezing of gait Questionnaire score
Gait qualitative performance with TMT6 weeksTinetti mobility test - Gait section score
Gait qualitative performance with DYPAGS6 weeksDynamic Parkinson Gait Scale score
Balance qualitative performance with the TMT6 weeksTinetti mobility test - Balance section score
Balance qualitative performance with the MiniBest6 weeksMiniBest test score
Mobility6 weeksTime taken to perform Timed-up and go test (s)
Range of motion of lower limb joint (°)6 weeksKinematic 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).

Countries

Spain

Contacts

Primary ContactConstanza San Martín, PhD.
constanza.martin@uv.es963864768
Backup ContactLuz Sánchez, PhD.
M.Luz.Sanchez@uv.es963983853

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026