Action Observation and Motor Imagery Therapy in Parkinson's Disease

Sponsor
Karamanoğlu Mehmetbey University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06154356
Collaborator
Karaman Training and Research Hospital (Other)
54
1
2
12.1
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Action observation and motor imagery therapy for rehabilitation
  • Other: Sham action observation and motor imagery therapy for rehabilitation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized controlled studyProspective randomized controlled study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Action Observation and Motor Imagery Therapy on Balance, Functional Status and Quality of Life in Parkinson's Disease, Randomized Controlled Trial
Anticipated Study Start Date :
Nov 30, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Other: Action observation and motor imagery therapy for rehabilitation
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.

Other: Sham 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.

Outcome Measures

Primary Outcome Measures

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

  2. The difference in the scores of the Unified Parkinson's Disease Rating Scale (UPDRS) between pre- and post-rehabilitation assessments [6 weeks]

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

  3. The difference in the scores of the Timed Up and Go Test (TUG) between pre- and post-rehabilitation assessments [6 weeks]

    Univariate statistical analyses will be performed to calculate differences in the scores of the TUG test between pre- and post-rehabilitation assessments

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

Secondary Outcome Measures

  1. The difference in the scores of the Parkinson's Disease Questionnaire (PDQ-39) between pre- and post-rehabilitation assessments [6 weeks]

    Univariate statistical analyses will be performed to calculate differences in the scores of the PDQ-39 between pre- and post-rehabilitation assessments

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

  3. The difference in the scores of the Hoehn and Yahr scale between pre- and post-rehabilitation assessments [6 weeks]

    Univariate statistical analyses will be performed to calculate differences in the scores of the Parkinson's Hoehn and Yahr Staging between pre- and post-rehabilitation assessments

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karaman Training and Research Hospital Karaman Turkey 70200

Sponsors and Collaborators

  • Karamanoğlu Mehmetbey University
  • Karaman Training and Research Hospital

Investigators

  • Principal Investigator: Yurdagul Bahran Mustu, MD., Karaman Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yurdagül Bahran Muştu, MD, Karamanoğlu Mehmetbey University
ClinicalTrials.gov Identifier:
NCT06154356
Other Study ID Numbers:
  • E-11095095-050.01.04-154055
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023