NCT07193355

Brief Summary

Parkinson's disease (PD) is the second most common neurodegenerative disease, characterized pathologically by the progressive loss of dopaminergic neurons in the substantia nigra and clinically by the presence of motor symptoms such as bradykinesia, resting tremor, and/or rigidity. Among the motor deficits frequently observed in PD, patients are known to frequently report difficulties with manual dexterity.Typical features of balance deficits in PD include decreased sway, decreased base of support, rigidity, abnormal intersegmental coordination, and postural misalignment. Related somatosensory deficits in PD include problems orienting to and processing sensory and somatosensory information.Motor imagery (MI) is the imaginal execution of motor activities or the activation of specific muscles in the absence of any explicit feedback. This area of rehabilitation has been shown to be effective in improving and developing motor skills in many neurological conditions where patients exhibit motor recognition and execution impairments. MI can be applied at all stages of recovery from PD, is highly effective in movement-related pathologies, and can be performed independently.Studies evaluating the effect of mental imagery training on balance measures in PD are limited. One study evaluating the effect of combined MI-physical therapy versus physical therapy alone group treatment noted positive trends toward balance improvements in the combined group. In a case study of a single participant with PD, a 3-month neurocognitive rehabilitation program incorporating mental imagery over 20 sessions resulted in balance improvements and a reduced risk of falls in both the "OFF" and "ON" phases, as measured by the Tinetti Balance and Gait Assessment Scale.The aim of this study is to investigate the effects of motor imagery training on kinesiophobia, walking and balance in patients with Parkinson's disease.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

September 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

September 12, 2025

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mental Chronometry with Timed up Go Test and Gyko device

    Mental chronometry is a method considered more objective than questionnaires in the assessment of MI, measuring imagery time. In other words, it examines the time difference between the actual physical execution of a movement and the mental imagery of the same movement. In the calculated mental chronometry value, a value of zero indicates perfect synchrony between motor imagery and motor execution. Values above zero indicate that the task was performed faster during motor imagery than during motor execution, and values below zero indicate that the task was performed slower during motor imagery than during motor execution. Patients' actual walking times (MIT) and imagery times (MET) are recorded. The difference in time and the mental chronometry ratio are calculated, and the mental chronometry ratio is evaluated using the following formula.In our study, the timed up and go test (TUG) and the gyko test will be used as mental chronometry tests.

    first day of the assessment and after the end of the treatment protocol (in the 5th week of the assessment) .

  • Tampa Kinesiophobia Scale

    The Tampa Kinesiophobia Scale (TKS) is a 17-question checklist developed to measure fear of movement and re-injury. Items are scored on a 4-point Likert scale (1: Strongly disagree, 4: Strongly agree). A total score is calculated by reversing items 4, 8, 12, and 16. A person receives a total score between 17 and 68. A total score of 37 points or higher indicates a high level of kinesiophobia. As a participant's score increases, so does the severity of their kinesiophobia. The use of the total score is recommended in studies. A Turkish version of the scale was developed and its reliability study was conducted in 2011.

    first day of the assesment and the 5th week of the treatment protocol.

  • The Gyko Device

    This device, manufactured by Mikrogate and manufactured in Italy, is used as a portable inertial measurement unit for motion analysis and postural stability assessment. The displacement of the center of gravity is analyzed using a computer using a sensor placed on a sling. The patient is asked to walk for 30 seconds.

    baseline and the 5th week of the treatment protocol.

Secondary Outcomes (5)

  • The Kinesthetic and Visual Imagery Questionnaire (KVIQ)-short form

    first day of the assesment and 5th week of the treatment protocol.

  • Modified Hoehn & Yahr (m-HY) Scale

    first day of the assesment and the 5th week of the treatment protocol.

  • sosyodemographic form

    first day of the assesment and the 5th week of the treatment protocol.

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    first day of the assesment and the 5th week of the treatment protocol.

  • Mini Mental State Examination (MMSE)

    first day of the assesment and the 5th week of the treatment protocol.

Study Arms (2)

study group

EXPERIMENTAL

'Mental Imagery Application Protocol' will be applied to this group. The timed up and go test (TUG) and gyko test will be used as mental chronometry tests with the patients of parkinson diesase.Therefore, the walking mental imagery protocol will be applied to this group.

Other: Mental Imagery Application Protocol

control group

NO INTERVENTION

This group will have routin medical treatment.

Interventions

Before the GYKO test, the patient will be asked to perform mental imagery to visualize a 3-meter distance for five cycles, and the time will be recorded. The TKYT will be administered according to standard protocols. Mental Imagery Application Protocol: 1. Awareness: The therapist will show a video of a typical normal gait for an adult male or female without pathology and compare it with a video of the patient's own gait. 2. Problem Identification/Explanation In the EG, subjects will identify gait problems and compare their gait with their typical gait. They will then use the comparative information for feedback. 3. Progressive Relaxation 4. Mental Imagery of Gait 5. Physıcal Performance Of The gait This protocol will be implemented the day after the initial assessment and will be conducted in 12 training sessions of no more than 90 minutes, three times per week for 4 weeks.

study group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 40-75 diagnosed with idiopathic PD, with a Modified Hoehn \& Yahr (m-HY) scale stage ≤4, and a score of ≥22 on the Mini Mental State Examination for those with formal training and ≥18 for those without formal training;
  • Individuals with no other known neurological and/or systemic disease;
  • Individuals without any upper extremity contractures;

You may not qualify if:

  • Individuals with diagnosed and/or treated psychiatric illnesses;
  • Individuals who are taking neuroleptic medications or antidepressants;
  • Individuals with orthopedic conditions such as severe dyskinesia, carpal tunnel syndrome, tendon injuries, and finger amputations that interfere with manual dexterity tests; rheumatological conditions such as rheumatoid arthritis and osteoarthritis; and individuals with any neurological disease other than PD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü imam University

Kahramanmaraş, Onikişubat, 46100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

hatice adıgüzel tat, Associate Proffessor

CONTACT

hatice Adiguzel tat, Associate Proffessor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 25, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

September 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations