- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154356
Action Observation and Motor Imagery Therapy in Parkinson's Disease
Effect of Action Observation and Motor Imagery Therapy on Balance, Functional Status and Quality of Life in Parkinson's Disease, Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Detailed Description
Parkinson's disease (PD) is a neurodegenerative disease with a chronic and progressive course. Freezing phenomena, gait disorders, and balance problems are common in PD. Gait and balance disorders and motor freezing attacks that occur as a result of PD increase the risk of falling, leading to a decrease in functional independence and quality of life. The main goal of Parkinson's rehabilitation is to ensure the maximum functional status and independence in daily living activities and to increase their quality of life.
In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yurdagul Bahran Mustu, MD.
- Phone Number: +90 506 209 76 72
- Email: yurdagulbahran@gmail.com
Study Contact Backup
- Name: Aynur Basaran, MD, Prof.
- Email: aynurbasaran@gmail.com
Study Locations
-
-
Karaman
-
Karaman, Karaman, Turkey (Türkiye), 70200
- Recruiting
- Karaman Training and Research Hospital
-
Contact:
- Yurdagul Bahran Mustu, MD.
- Phone Number: +90 338 226 3228
- Email: yurdagulbahran@gmail.com
-
Contact:
- Aynur Basaran, MD, Prof.
- Phone Number: +90 338 226 3225
- Email: aynurbasaran@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with a diagnosis of Parkinson's Disease
- Hoehn and Yahr Stage 1-3
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Action observation and motor imagery therapy for rehabilitation
Action observation and motor imagery therapy for rehabilitation in Parkinson's Disease in addition to conventional rehabilitation programs.
|
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. |
|
Sham Comparator: Sham action observation and motor imagery therapy for rehabilitation
Sham comparator for action observation and motor imagery therapy for rehabilitation in Parkinson's Disease in addition to conventional rehabilitation programs.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference in the scores of the Five Times Sit to Stand Test between pre- and post-rehabilitation assessments
Time Frame: 6 weeks
|
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
|
|
The difference in the scores of the Berg Balance Scale between pre- and post-rehabilitation assessments
Time Frame: 6 weeks
|
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
Time Frame: 6 weeks
|
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
Time Frame: 6 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference in the scores of the Parkinson's Disease Questionnaire between pre- and post-rehabilitation assessments
Time Frame: 6 weeks
|
Univariate statistical analyses will be performed to calculate differences in the scores of the Parkinson's Disease Questionnaire (PDQ-39) between pre- and post-rehabilitation assessments. Parkinson's Disease Questionnaire consists of a total of 39 items and eight subgroups. In the survey, each item is scored between 0 and 4. Lower scores indicate better quality of life. |
6 weeks
|
|
The difference in the scores of the Freezing of Gait Questionnaire between pre- and post-rehabilitation assessments
Time Frame: 6 weeks
|
Univariate statistical analyses will be performed to calculate differences in the scores of the Freezing of Gait Questionnaire between pre- and post-rehabilitation assessments. Freezing of Gait Questionnaire consists of six questions. Each question has a 5-point scale, where 0 means an absence of symptoms and 4 represents the worst stage. The total score on the Freezing of Gait Questionnaire ranges from 0 to 24 points. The higher the score is, the more the Freezing of Gait is pronounced. |
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yurdagul Bahran Mustu, MD., Karaman Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Aftercare
- Continuity of Patient Care
- Rehabilitation
Other Study ID Numbers
- 09-2023/03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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