NCT04788693

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

March 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
4.5 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

March 1, 2021

Last Update Submit

October 8, 2024

Conditions

Keywords

Gait rehabilitationMotor imageryBiomechanics of gaitParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 weeks

Secondary Outcomes (26)

  • Gait speed variability

    6 weeks

  • Maximum gait speed

    6 weeks

  • Stance time

    6 weeks

  • Weight-acceptance Ground Reaction Force (Newton, N; Weight%)

    6 weeks

  • Midstance Ground Reaction Force (Newton, N; Weight%)

    6 weeks

  • +21 more secondary outcomes

Study Arms (2)

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.

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.

Other: Physical rehabilitation of gait without motor imagery

Interventions

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.

Also known as: GAITimagery program
Motor imagery and gait training group

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.

Also known as: Gait physiotherapy program
Gait training group without motor imagery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (14)

  • 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.

    PMID: 38189921BACKGROUND
  • 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.

    PMID: 37774517BACKGROUND
  • 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.

    PMID: 34286884BACKGROUND
  • 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.

    PMID: 35488213BACKGROUND
  • 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.

    PMID: 33333508BACKGROUND
  • 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.

    PMID: 35247729BACKGROUND
  • 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.

    PMID: 26484518BACKGROUND
  • 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.

    PMID: 31327026BACKGROUND
  • 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.

    PMID: 21402327BACKGROUND
  • 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.

    PMID: 27777809BACKGROUND
  • 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.

    PMID: 30470657BACKGROUND
  • 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.

    PMID: 27375451BACKGROUND
  • 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.

    PMID: 36052889BACKGROUND
  • 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.

    PMID: 17172556BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Constanza San Martín, PhD.

    Associate Lecturer professor at the Department of Physiotherapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Constanza San Martín, PhD.

CONTACT

Luz Sánchez, PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Lecturer professor at the Department of Physiotherapy

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 9, 2021

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

All measured and recorded data will be shared through the publications made and through their supplementary material.

Locations