NCT06154356

Brief Summary

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in Parkinson's disease (PD). Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind. The aim of this clinical trial is to test whether the application of AO and MI treatment in PD in addition to conventional rehabilitation programs has an additional effect on Balance, Functional Status and Quality of Life.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Dec 2023

Typical duration for not_applicable

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 Progress97%
Dec 2023Jun 2026

First Submitted

Initial submission to the registry

November 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

December 14, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

November 23, 2023

Last Update Submit

December 4, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • The difference in the scores of the Berg Balance Scale between pre- and post-rehabilitation assessments

    Univariate statistical analyses will be performed to calculate differences in the scores of the Berg Balance Scale between pre- and post-rehabilitation assessments. Berg Balance Scale consists of 14 items. Total score ranges from 0 to 56. Higher scores indicate better balance.

    6 weeks

  • The difference in the scores of the The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale pre- and post-rehabilitation assessments

    Univariate statistical analyses will be performed to calculate differences in the scores of the The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale between pre- and post-rehabilitation assessments. The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) consists of four sections: Part 1: non-motor experiences of daily living, Part 2: motor experiences of daily living, Part 3: motor examination, Part 4: motor complications. It consists of a total of 50 questions. In this study, sections II (motor experiences of daily living) and III (motor examination) will be used. Each item is is scored between 0 and 4. Higher values indicate that the patient's condition is worse.

    6 weeks

  • The difference in the scores of the Timed Up and Go Test between pre- and post-rehabilitation assessments

    Univariate statistical analyses will be performed to calculate differences in the scores of the Timed Up and Go Test between pre- and post-rehabilitation assessments

    6 weeks

  • The difference in the scores of the Five Times Sit to Stand Test between pre- and post-rehabilitation assessments

    Univariate statistical analyses will be performed to calculate differences in the scores of the Five Times Sit to Stand Test between pre- and post-rehabilitation assessments

    6 weeks

Secondary Outcomes (2)

  • The difference in the scores of the Parkinson's Disease Questionnaire between pre- and post-rehabilitation assessments

    6 weeks

  • The difference in the scores of the Freezing of Gait Questionnaire between pre- and post-rehabilitation assessments

    6 weeks

Study Arms (2)

Action observation and motor imagery therapy for rehabilitation

EXPERIMENTAL

Action observation and motor imagery therapy for rehabilitation in Parkinson's Disease in addition to conventional rehabilitation programs.

Other: Action observation and motor imagery therapy for rehabilitation

Sham action observation and motor imagery therapy for rehabilitation

SHAM COMPARATOR

Sham comparator for action observation and motor imagery therapy for rehabilitation in Parkinson's Disease in addition to conventional rehabilitation programs.

Other: Sham action observation and motor imagery therapy for rehabilitation

Interventions

Action observation; Patients will watch some exercises accompanied by music from a previously prepared video for 10 minutes. Exercises include 8-10 repetitions of abduction-adduction, horizontal abduction-adduction, flexion-extension and supination-pronation movements for the upper extremity, and stepping, forward-backward stepping, side stepping and ankle dorsiflexion movements for the lower extremity. Motor imagery training; Patients will be asked to visualize the actions they watched in their minds for 10 minutes. Then the patients will watch the video again and will be asked to perform the exercises while watching.

Action observation and motor imagery therapy for rehabilitation

Sham action observation; Patients will watch a video consisting of static nature photographs for 10 minutes with the same music. Sham motor imaginary; Patients will think about the video they watched for 10 minutes. Then, they will watch another video in which the exercises are performed only once, and they will be asked to do the exercises. They will be given enough time to do 8-10 repetitions.

Sham action observation and motor imagery therapy for rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of Parkinson's Disease
  • Hoehn and Yahr Stage 1-3

You may not qualify if:

  • Patients with cognitive dysfunction (those who cannot follow simple verbal instructions)
  • Patients with severe hearing problems
  • Patients with severe vision problems
  • Patients with additional musculoskeletal system pathology that will affect physical performance (such as amputation, severe joint mobility limitation, peripheral nerve damage)
  • Patients with uncontrolled hypertension and diabetes mellitus
  • Patients with a history of symptomatic lung disease (such as asthma, chronic obstructive pulmonary disease, emphysema)
  • Patients with a history of symptomatic cardiac disease (such as coronary artery disease, arrhythmia, heart failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Karaman, 70200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yurdagul Bahran Mustu, MD.

    Karaman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yurdagul Bahran Mustu, MD.

CONTACT

Aynur Basaran, MD, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Principal investigator

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 4, 2023

Study Start

December 14, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations