search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical rehabilitation of gait with motor imagery
Physical rehabilitation of gait without motor imagery
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Gait rehabilitation, Motor imagery, Biomechanics of gait, Parkinson's disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Motor imagery and gait training group

    Gait training group without motor imagery

    Arm Description

    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. 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 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. In the periods that the experimental group performs the motor imagery exercises, the control group will take breaks.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Change from Baseline Stride length at 6 weeks
    Distance measured between two consecutive supports of the same foot, heel support is the reference used. It is expressed in meters (m).

    Full Information

    First Posted
    March 1, 2021
    Last Updated
    December 26, 2022
    Sponsor
    University of Valencia
    Collaborators
    Asociación de enfermos y familiares de Parkinson - CIRENC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04788693
    Brief Title
    Effects of Gait Rehabilitation With Motor Imagery in People With Parkinson's Disease
    Acronym
    GAITimagery
    Official Title
    Effects of Gait Rehabilitation With Motor Imagery in People With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Valencia
    Collaborators
    Asociación de enfermos y familiares de Parkinson - CIRENC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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 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: 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 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Gait rehabilitation, Motor imagery, Biomechanics of gait, Parkinson's disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Assignment of participants to treatment groups will be hidden from the evaluator. In addition, the subjects will not know the group to which they are assigned, since both groups will carry out an identical gait rehabilitation program except for the fact that at the times when the participants in the experimental group carry out motor imagery.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motor imagery and gait training group
    Arm Type
    Experimental
    Arm Description
    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. 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.
    Arm Title
    Gait training group without motor imagery
    Arm Type
    Active Comparator
    Arm Description
    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. In the periods that the experimental group performs the motor imagery exercises, the control group will take breaks.
    Intervention Type
    Other
    Intervention Name(s)
    Physical rehabilitation of gait with motor imagery
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Physical rehabilitation of gait without motor imagery
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Gait velocity at 6 weeks
    Description
    Distance traveled by the body per unit of time, in the direction considered. It is expressed in meters per second (m / s).
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Stride length at 6 weeks
    Description
    Distance measured between two consecutive supports of the same foot, heel support is the reference used. It is expressed in meters (m).
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luz Sánchez, PhD.
    Phone
    963983853
    Email
    M.Luz.Sanchez@uv.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Constanza San Martín, PhD.
    Phone
    963864768
    Email
    constanza.martin@uv.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luz Sánchez, PhD.
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31327026
    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.
    Results Reference
    background
    PubMed Identifier
    21402327
    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.
    Results Reference
    background
    PubMed Identifier
    27777809
    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.
    Results Reference
    background
    PubMed Identifier
    30470657
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27375451
    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.
    Results Reference
    background
    PubMed Identifier
    26484518
    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 Parkinson's disease: Randomized clinical trial. NeuroRehabilitation. 2015;37(2):263-71. doi: 10.3233/NRE-151259.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs