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

Parkinson Disease Clinical Trial

— GAITimagery  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788693
• Other study ID #: 1557673
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: University of Valencia
• Contact: Constanza San Martín, PhD.
• Phone: 963864768
• Email: constanza.martin[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 the biomechanics of 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 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 3 months after the intervention has finished. In each evaluation session, a clinical part and a biomechanical part 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 evaluation 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 the training of kinematic milestones during the stance and oscillation phase of gait through the mobility of the ankle, knee, and hip joints. The motor imagery exercises within a session will be performed in a sitting position prior to each gait exercise. The instructions will be administered through a voice recording. The subject 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 subject 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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being diagnosed with PD according to the United Kingdom Parkinson's Disease Society Brain Bank diagnostic scale, ratified through a report made by the neurologist
• To present a score from I to III on the Hoehn and Yahr scale, which implies not requiring support or help from a third person to walk
• To not present alteration in their cognitive state, determined by a score higher than 25 in the Mini-Mental State Examination
• To have stable medication from the month prior to the start of the study until the complete conclusion of the study.

Exclusion Criteria:

• To present another pathology or neurological alteration different from Parkinson's disease
• To present an acute clinical presentation of musculoskeletal disease or disorder that limits mobility;
• To report pain greater than 3 points on the Visual Analogue Scale
• To suffer blindness, deafness and / or any other visual / auditory alteration or pathology that may influence the ability to understand instructions and carry them out
• To present uncontrolled chronic diseases
• To suffer balance impairments due to other diseases.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Asociación Parkinson Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Bek J, Gowen E, Vogt S, Crawford TJ, Poliakoff E. Combined action observation and motor imagery influences hand movement amplitude in Parkinson's disease. Parkinsonism Relat Disord. 2019 Apr;61:126-131. doi: 10.1016/j.parkreldis.2018.11.001. Epub 2018 Nov 9. No abstract available. — View Citation

Bek J, Webb J, Gowen E, Vogt S, Crawford TJ, Sullivan MS, Poliakoff E. Patients' Views on a Combined Action Observation and Motor Imagery Intervention for Parkinson's Disease. Parkinsons Dis. 2016;2016:7047910. doi: 10.1155/2016/7047910. Epub 2016 Sep 29. — View Citation

Braun S, Beurskens A, Kleynen M, Schols J, Wade D. Rehabilitation with mental practice has similar effects on mobility as rehabilitation with relaxation in people with Parkinson's disease: a multicentre randomised trial. J Physiother. 2011;57(1):27-34. doi: 10.1016/S1836-9553(11)70004-2. — View Citation

Santiago LM, de Oliveira DA, de Macedo Ferreira LG, de Brito Pinto HY, Spaniol AP, de Lucena Trigueiro LC, Ribeiro TS, de Sousa AV, Piemonte ME, Lindquist AR. Immediate effects of adding mental practice to physical practice on the gait of individuals with — View Citation

Scarpina F, Magnani FG, Tagini S, Priano L, Mauro A, Sedda A. Mental representation of the body in action in Parkinson's disease. Exp Brain Res. 2019 Oct;237(10):2505-2521. doi: 10.1007/s00221-019-05608-w. Epub 2019 Jul 20. — View Citation

Subramanian L, Morris MB, Brosnan M, Turner DL, Morris HR, Linden DE. Functional Magnetic Resonance Imaging Neurofeedback-guided Motor Imagery Training and Motor Training for Parkinson's Disease: Randomized Trial. Front Behav Neurosci. 2016 Jun 8;10:111. doi: 10.3389/fnbeh.2016.00111. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Gait velocity at 6 weeks	Distance traveled by the body per unit of time, in the direction considered. It is expressed in meters per second (m / s).	6 weeks
Secondary	Stride length	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
Secondary	Speed variability	Variability of walking speed estimated from the repetitions performed at each measurement time.	6 weeks
Secondary	Support/ Stance time (s)	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.	6 weeks
Secondary	Cadence (steps/min)	Number of steps executed in a time interval, its most commonly adopted unit being the step per minute.	6 weeks
Secondary	Swing time	Time elapsed while the swing phase develops. It is expressed as a percentage according to the entire walking cycle.	6 weeks
Secondary	Range of motion of lower limb joint (°)	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
Secondary	Maximum ankle dorsiflexion during swing (°)	Kinematic outcome; Maximum ankle dorsiflexion angle reached during the swing phase, expressed in degrees.	6 weeks
Secondary	Maximum knee flexion during swing (°)	Kinematic outcome; Maximum knee flexion angle reached during the swing phase, expressed in degrees.	6 weeks
Secondary	Maximum hip extension during stance (°)	Kinematic outcome; Maximum hip extension angle reached during the stance phase, expressed in degrees.	6 weeks
Secondary	Maximum hip flexion during swing (°)	Kinematic outcome; Maximum hip flexion angle reached during the swing phase, expressed in degrees.	6 weeks
Secondary	Weight-acceptance Ground Reaction Force (Newton, N; Weight%)	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
Secondary	Midstance Ground Reaction Force (Newton, N; Weight%)	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
Secondary	Push-off Ground Reaction Force (Newton, N; Weight%)	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
Secondary	Breaking Ground Reaction Force (Newton, N; Weight%)	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
Secondary	Propulsion Ground Reaction Force (Newton, N; Weight%)	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
Secondary	Quality of Life referred	Schwab & England scale score; Parkinson's Disease Questionnaire-39 score	6 weeks
Secondary	Freezing of gait	Freezing of gait Questionnaire score	6 weeks
Secondary	Gait qualitative performance	Tinetti mobility test - Gait section score; Dynamic Parkinson Gait Scale score	6 weeks
Secondary	Balance qualitative performance	Tinetti mobility test - Balance section score	6 weeks
Secondary	Mobility	Timed-up and go test (s)	6 weeks