NCT05696925

Brief Summary

Parkinson's disease is degenerative, progressive, and chronic. It is considered potentially disabling, in view of the motor alterations, such as bradykinesia, rigidity, and tremor in the upper limbs, and non-motor alterations, such as cognitive ones involving attention, concentration and memory difficulties. Thus, neurorehabilitation modalities, such as motor imagery and action observation, have been used. The aim of this research is to investigate the effects of motor imagery and action observation on upper limb motor and cognitive changes in Parkinson's disease. This is a randomized controlled trial type study. The population of the study involves people with Parkinson's disease in stages 1-3 on the Hoehn and Yahr scale, aged 20 to 80 years, who must be on stable medication, have no cognitive impairment with risk of dementia, be able to imagine motor activities and have upper limb motor impairment. The study groups will be: a) motor imagery, observation of action and motor execution; b) motor imagery and motor execution; c) observation of action and motor execution; d) motor imagery and motor execution and exoskeleton; e) observation of action and motor execution and exoskeleton. The interventions of all groups will be an intensive approach of 10 continuous sessions, with a two-day break in the middle of the intervention, totaling two weeks, with each session lasting 40 minutes a day. The data collection steps for the study will involve the pre-test, the interventions, the immediate post-test, and the test after a four-week period without intervention. The instruments that will be used for the evaluations will be: a) part of the Unified Parkinson's Disease Rating Scale (UPDRS-III); b) Test D'évaluation Des Membres Supérieurs Des Personnes Âgées (TEMPA); c) 9-Hole Peg Test to assess upper extremity function; d) Parkinson's Disease Cognitive Assessment Scale; e) Canadian Occupational Performance Measure to identify performance and satisfaction in performing activities in the areas of self-care, productivity, and leisure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 18, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

October 18, 2022

Last Update Submit

April 22, 2025

Conditions

Keywords

Parkinson DiseaseMotor ImageryAction ObservationUpper LimbCognition

Outcome Measures

Primary Outcomes (1)

  • Parkinson's Disease-Cognitive Rating Scale

    The Parkinson's Disease Cognitive Rating Scale (PD-CRS) arises from the need for a more comprehensive approach to the cognitive assessment of front-subcortical and cortical functions impaired throughout PD. In PD-CRS there are nine functions assessed, seven involving the "frontal-subcortical": sustained attention, working memory, the immediate and delayed evocation of verbal memory (word list), alternating verbal fluency, verbal fluency of actions, and spontaneous clock drawing; and two involving the "posterior cortical": naming twenty figures by visual confrontation, added to copying the clock drawing. The administration time is approximately 20 minutes, and training is available in the public domain. The total score of the PD-CRS is 134 points, with the ideal cutoff score being 81 points, and a score less than or equal to 64 points indicates PD with dementia.

    Pre Test: one day before the intervention; Pos Test: one day after the intervention.

Secondary Outcomes (4)

  • Unified Parkinson's Disease Rating Scale of the Movement Disorders Society

    Pre Test: one day before the intervention; Pos Test: one day after the intervention (last session).

  • Test TEMPA

    Pre Test: one day before the intervention; Pos Test: one day after the intervention (last session).

  • 9-Hole Peg Test

    Pre Test: one day before the intervention; Pos Test: one day after the intervention.

  • Canadian Occupational Performance Measure

    Pre Test: one day before the intervention; Pos Test: one day after the intervention (last session).

Study Arms (5)

motor imagery, observation of the action, and execution of the action (GE1)

EXPERIMENTAL

in the sitting position, the participant will watch the recorded video to observe the action, for two minutes. Soon after, they will close their eyes, and receive the description of the action, through recorded audio of the same action, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 60 minutes of intervention.

Other: Motor ImageryOther: Action ObservationOther: Execution of the Action

motor imagery and execution of the action (GE2)

EXPERIMENTAL

in the sitting position, the participant will close his eyes and will receive the description of the action, through recorded audio, to imagine it, for two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 40 minutes of intervention.

Other: Motor ImageryOther: Execution of the Action

action observation and action execution (GE3)

EXPERIMENTAL

in the sitting position, the participant will watch the recorded video to perform the action observation, which will last two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action observed previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 40 minutes of intervention.

Other: Action ObservationOther: Execution of the Action

motor imagery, execution of the action, and exoskeleton (GE4)

EXPERIMENTAL

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes. Then, the participant will close his eyes and will receive the description of the action, through recorded audio, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

Other: Motor ImageryOther: ExoskeletonsOther: Execution of the Action

observation of the action, execution of the action, and exoskeleton (GE5)

EXPERIMENTAL

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes. Then, the participant will watch the recorded video to observe the action, for two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action observed previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

Other: Action ObservationOther: ExoskeletonsOther: Execution of the Action

Interventions

Motor imagery (MI) is a cognitive process that involves the ability to perform an action mentally, without the need to perform the movement itself. The perspective that the person uses to imagine can be: internal perspective (first person - imagines himself/herself), which relates to the person's view of the content of the images or to his/her kinesthetic sensation - the person imagines the movement being performed, as if feeling the movement of the action; or external perspective (third person - imagines another person), which relates to the visual imagination of scenes outside the person.

motor imagery and execution of the action (GE2)motor imagery, execution of the action, and exoskeleton (GE4)motor imagery, observation of the action, and execution of the action (GE1)

Action observation consists of watching another person acting, or doing a motor task, on video or in real-time.

action observation and action execution (GE3)motor imagery, observation of the action, and execution of the action (GE1)observation of the action, execution of the action, and exoskeleton (GE5)

The term Brain-Machine Interface (BMI) refers to systems that capture brain activity signals, translating them into computer commands to control external devices, with the robotic exoskeletons. The electrodes are positioned on the skull cap.

Also known as: Brain-Machine Interface
motor imagery, execution of the action, and exoskeleton (GE4)observation of the action, execution of the action, and exoskeleton (GE5)

In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined or observed previously.

action observation and action execution (GE3)motor imagery and execution of the action (GE2)motor imagery, execution of the action, and exoskeleton (GE4)motor imagery, observation of the action, and execution of the action (GE1)observation of the action, execution of the action, and exoskeleton (GE5)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have a diagnosis of Parkinson's disease and be in stage 1-3, consistent with a mild and moderate disability;
  • be aged between 20 years old to 80 years old;
  • be on stable use of medication;
  • no dementia;
  • be minimally capable of imagining motor activities;
  • present motor alteration in the dominant upper limb;
  • have signed the Informed Consent Form.

You may not qualify if:

  • not present additional central nervous system disorders or other conditions that may affect upper and lower extremity function;
  • present with other uncontrolled chronic conditions that may interfere with the participant's safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFCSPA

Porto Alegre, Brazil

Location

Related Publications (1)

  • Estivalet KM, Pettenuzzo TSA, Mazzilli NL, Ferreira LF, Cechetti F. The use of brain-machine interface, motor imagery, and action observation in the rehabilitation of individuals with Parkinson's disease: A protocol study for a randomized clinical trial. PLoS One. 2025 Apr 7;20(4):e0315148. doi: 10.1371/journal.pone.0315148. eCollection 2025.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exoskeleton DeviceBrain-Computer Interfaces

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and SuppliesElectrical Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Ph.D Fernanda Cechetti

Study Record Dates

First Submitted

October 18, 2022

First Posted

January 25, 2023

Study Start

February 1, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations