Parkinson DiseaseGAITimageryNCT04788693

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

A study testing Physical rehabilitation of gait with motor imagery and Physical rehabilitation of gait without motor imagery in people with Parkinson Disease, run by University of Valencia at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
What is being tested?: Physical rehabilitation of gait with motor imagery and Physical rehabilitation of gait without motor imagery
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteSpain
Study dates: Sep 2025to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Constanza San Martín, PhD. contact

963864768

constanza.martin@uv.es

Luz Sánchez, PhD. contact

963983853

M.Luz.Sanchez@uv.es

Spain1 site

University of Valencia
Valencia, 46010
Luz Sanchez, PhD, +34 963983853, m.luz.sanchez@uv.es

Other trials in Spain

About this study

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.

Read the 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:

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.

Conditions: Parkinson Disease
Being tested: Physical rehabilitation of gait with motor imagery, Physical rehabilitation of gait without motor imagery
Keywords: Gait rehabilitation, Motor imagery, Biomechanics of gait, Parkinson's disease
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical rehabilitation of gait with motor imageryOther
Also called GAITimagery program
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 imageryOther
Also called Gait physiotherapy program
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.

Study groups in NCT04788693
Study group	Role	What they receive
Motor imagery and gait training group	Experimental	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. Receives: Other: Physical rehabilitation of gait with motor imagery
Gait training group without motor imagery	Active comparator	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. Receives: Other: Physical rehabilitation of gait without motor imagery

What is being measured

The primary outcome is the main question the study is designed to answer.

Gait velocity at the post-training time (primary time point)
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).
Measured: 6 weeks

Secondary outcomes (26)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2025Dec 2026

First posted9 Mar 2021
Study startSep 2025 (estimated)
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by University of ValenciaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 74 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04788693
Sponsor's protocol ID: 1557673
Acronym: GAITimagery
Status last verified: Oct 2024
First submitted: 1 Mar 2021
Last updated: 15 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: All measured and recorded data will be shared through the publications made and through their supplementary material.

Publications

Leocadi M, Canu E, Sarasso E, Gardoni A, Basaia S, Calderaro D, Castelnovo V, Volonte MA, Filippi M, Agosta F. Dual-task gait training improves cognition and resting-state functional connectivity in Parkinson's disease with postural instability and gait disorders. J Neurol. 2024 Apr;271(4):2031-2041. doi: 10.1007/s00415-023-12151-w. Epub 2024 Jan 8.
PubMed 38189921
Sarasso E, Gardoni A, Zenere L, Canu E, Basaia S, Pelosin E, Volonte MA, Filippi M, Agosta F. Action observation and motor imagery improve motor imagery abilities in patients with Parkinson's disease - A functional MRI study. Parkinsonism Relat Disord. 2023 Nov;116:105858. doi: 10.1016/j.parkreldis.2023.105858. Epub 2023 Sep 22.
PubMed 37774517
Sarasso E, Agosta F, Piramide N, Gardoni A, Canu E, Leocadi M, Castelnovo V, Basaia S, Tettamanti A, Volonte MA, Filippi M. Action Observation and Motor Imagery Improve Dual Task in Parkinson's Disease: A Clinical/fMRI Study. Mov Disord. 2021 Nov;36(11):2569-2582. doi: 10.1002/mds.28717. Epub 2021 Jul 19.
PubMed 34286884
Kashif M, Ahmad A, Bandpei MAM, Gilani SA, Hanif A, Iram H. Combined effects of virtual reality techniques and motor imagery on balance, motor function and activities of daily living in patients with Parkinson's disease: a randomized controlled trial. BMC Geriatr. 2022 Apr 30;22(1):381. doi: 10.1186/s12877-022-03035-1.
PubMed 35488213
Kashif M, Ahmad A, Bandpei MAM, Gillani SA, Hanif A, Iram H. Effects of Virtual Reality with Motor Imagery Techniques in Patients with Parkinson's Disease: Study Protocol for a Randomized Controlled Trial. Neurodegener Dis. 2020;20(2-3):90-96. doi: 10.1159/000511916. Epub 2020 Dec 17.
PubMed 33333508
Tinaz S, Kamel S, Aravala SS, Elfil M, Bayoumi A, Patel A, Scheinost D, Sinha R, Hampson M. Neurofeedback-guided kinesthetic motor imagery training in Parkinson's disease: Randomized trial. Neuroimage Clin. 2022;34:102980. doi: 10.1016/j.nicl.2022.102980. Epub 2022 Mar 2.
PubMed 35247729
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.
PubMed 26484518
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.
PubMed 31327026
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.
PubMed 21402327
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.
PubMed 27777809
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.
PubMed 30470657
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.
PubMed 27375451
Bezerra PT, Santiago LM, Silva IA, Souza AA, Pegado CL, Damascena CM, Ribeiro TS, Lindquist AR. Action observation and motor imagery have no effect on balance and freezing of gait in Parkinson's disease: a randomized controlled trial. Eur J Phys Rehabil Med. 2022 Oct;58(5):715-722. doi: 10.23736/S1973-9087.22.07313-0. Epub 2022 Sep 1.
PubMed 36052889
Tamir R, Dickstein R, Huberman M. Integration of motor imagery and physical practice in group treatment applied to subjects with Parkinson's disease. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):68-75. doi: 10.1177/1545968306292608.
PubMed 17172556

Interested in taking part?

Constanza San Martín, PhD.

963864768

constanza.martin@uv.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Gait Rehabilitation With Motor Imagery in People With Parkinson's Disease
ClinicalTrials.gov ID: NCT04788693
Acronym / sponsor ID: GAITimagery / 1557673
Conditions: Parkinson Disease
Keywords: Gait rehabilitation, Motor imagery, Biomechanics of gait, Parkinson's disease
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 74 participants (estimated)
Lead sponsor: University of ValenciaUniversity, hospital or other
Collaborators: Asociación Parkinson Valencia
Study start: Sep 2025 (estimated)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 9 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background:

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:

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Motor imagery and gait training group	Experimental	Other: Physical rehabilitation of gait with motor imageryGait 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.
Gait training group without motor imagery	Active comparator	Other: Physical rehabilitation of gait without motor imageryGait 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical rehabilitation of gait with motor imageryAlso: GAITimagery programPhysical 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	Motor imagery and gait training group
Physical rehabilitation of gait without motor imageryAlso: Gait physiotherapy programPhysical 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	Gait training group without motor imagery

Primary outcome

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).

26 secondary outcomes

Gait speed variability
Time frame: 6 weeks
Maximum gait speed
Time frame: 6 weeks
Stance time
Time frame: 6 weeks
Weight-acceptance Ground Reaction Force (Newton, N; Weight%)
Time frame: 6 weeks
Midstance Ground Reaction Force (Newton, N; Weight%)
Time frame: 6 weeks
Push-off Ground Reaction Force (Newton, N; Weight%)
Time frame: 6 weeks
Breaking Ground Reaction Force (Newton, N; Weight%)
Time frame: 6 weeks
Propulsion Ground Reaction Force (Newton, N; Weight%)
Time frame: 6 weeks
Cadence (steps/min)
Time frame: 6 weeks
Stride length
Time frame: 6 weeks
Step length
Time frame: 6 weeks
Swing time
Time frame: 6 weeks
Double support time
Time frame: 6 weeks
Range of motion of lower limb joint (°)
Time frame: 6 weeks
Maximum ankle dorsiflexion during swing (°)
Time frame: 6 weeks
Maximum knee flexion during swing (°)
Time frame: 6 weeks
Maximum hip extension during stance (°)
Time frame: 6 weeks
Maximum hip flexion during swing (°)
Time frame: 6 weeks
Activities of daily life
Time frame: 6 weeks
Quality of Life perceived
Time frame: 6 weeks
Freezing of gait
Time frame: 6 weeks
Gait qualitative performance with TMT
Time frame: 6 weeks
Gait qualitative performance with DYPAGS
Time frame: 6 weeks
Balance qualitative performance with the TMT
Time frame: 6 weeks
Balance qualitative performance with the MiniBest
Time frame: 6 weeks
Mobility
Time frame: 6 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Background: PubMed 38189921Leocadi M, Canu E, Sarasso E, Gardoni A, Basaia S, Calderaro D, Castelnovo V, Volonte MA, Filippi M, Agosta F. Dual-task gait training improves cognition and resting-state functional connectivity in Parkinson's disease with postural instability and gait disorders. J Neurol. 2024 Apr;271(4):2031-2041. doi: 10.1007/s00415-023-12151-w. Epub 2024 Jan 8.
Background: PubMed 37774517Sarasso E, Gardoni A, Zenere L, Canu E, Basaia S, Pelosin E, Volonte MA, Filippi M, Agosta F. Action observation and motor imagery improve motor imagery abilities in patients with Parkinson's disease - A functional MRI study. Parkinsonism Relat Disord. 2023 Nov;116:105858. doi: 10.1016/j.parkreldis.2023.105858. Epub 2023 Sep 22.
Background: PubMed 34286884Sarasso E, Agosta F, Piramide N, Gardoni A, Canu E, Leocadi M, Castelnovo V, Basaia S, Tettamanti A, Volonte MA, Filippi M. Action Observation and Motor Imagery Improve Dual Task in Parkinson's Disease: A Clinical/fMRI Study. Mov Disord. 2021 Nov;36(11):2569-2582. doi: 10.1002/mds.28717. Epub 2021 Jul 19.
Background: PubMed 35488213Kashif M, Ahmad A, Bandpei MAM, Gilani SA, Hanif A, Iram H. Combined effects of virtual reality techniques and motor imagery on balance, motor function and activities of daily living in patients with Parkinson's disease: a randomized controlled trial. BMC Geriatr. 2022 Apr 30;22(1):381. doi: 10.1186/s12877-022-03035-1.
Background: PubMed 33333508Kashif M, Ahmad A, Bandpei MAM, Gillani SA, Hanif A, Iram H. Effects of Virtual Reality with Motor Imagery Techniques in Patients with Parkinson's Disease: Study Protocol for a Randomized Controlled Trial. Neurodegener Dis. 2020;20(2-3):90-96. doi: 10.1159/000511916. Epub 2020 Dec 17.
Background: PubMed 35247729Tinaz S, Kamel S, Aravala SS, Elfil M, Bayoumi A, Patel A, Scheinost D, Sinha R, Hampson M. Neurofeedback-guided kinesthetic motor imagery training in Parkinson's disease: Randomized trial. Neuroimage Clin. 2022;34:102980. doi: 10.1016/j.nicl.2022.102980. Epub 2022 Mar 2.
Background: PubMed 26484518Santiago 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.
Background: PubMed 31327026Scarpina 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.
Background: PubMed 21402327Braun 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.
Background: PubMed 27777809Bek 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.
Background: PubMed 30470657Bek 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.
Background: PubMed 27375451Subramanian 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.
Individual participant dataSharing planned: No. All measured and recorded data will be shared through the publications made and through their supplementary material.

Related trials for Parkinson Disease

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Constanza San Martín, PhD. contact

963864768

constanza.martin@uv.es

Luz Sánchez, PhD. contact

963983853

M.Luz.Sanchez@uv.es

Constanza San Martín, PhD. principal investigator

Associate Lecturer professor at the Department of Physiotherapy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Constanza San Martín, PhD. (963864768, constanza.martin@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait velocity at the post-training time (primary time point) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788693, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.