Effect of Virtual Reality on Freezing Phenomenon, Balance, Functional Mobility, Participation in Parkinson's Patients

Effect of Task-Oriented Virtual Reality Access With Crowd Simulation on Freezing Phenomenon, Balance, Functional Mobility, Participation and Quality of Life in Parkinson's Patients

This study was planned to investigate the use and results of virtual reality applications with specially prepared software for the rehabilitation of freezing phenomenon, which increases the falling anxiety of individuals with Parkinson's disease and causes social isolation. Individuals over the age of 50 who have been diagnosed with idiopathic Parkinson's disease by a specialist neurologist will be included in the study; Individuals evaluated in terms of balance, functional mobility, freezing phenomenon, participation, and cognitive status will be randomly divided into two groups receiving conventional treatment and additional virtual reality. After the preliminary evaluation, they will receive 8 weeks of treatment 4 days a week and will be evaluated after the treatment and 3 months after the treatment. In addition to the improvements that will emerge as a result of the treatments within the scope of the study, it is expected that the virtual reality application created with crowd simulation will provide more effective results in improving the parameters. Knowing the effects of exercises in crowds, which cannot be performed in the clinic, in the treatment of Parkinson's disease patients, whose freezing and freezing-related symptoms are aggravated, especially in crowded environments, will make significant contributions to the field.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease; Freezing of Gait
• Intervention / Treatment: Procedure: Conventional Parkinson Rehabilitation; Device: Task-Oriented Virtual Reality Application with Crowd Simulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ertuğrul DEMİRDEL, Assoc. Prof.; Phone Number: +903129061928; Email: edemirdel@aybu.edu.tr
• Study Contact Backup: Name: Özge BARUT ÇELİK, MSc.; Phone Number: +905527521401; Email: ozgebarut@ahievran.edu.tr

Study Locations

• Turkey
  • Maltepe
    • Ankara, Maltepe, Turkey, 06570
      • Gazi University
      • Contact: ÖNER BARUT, Asst. Prof.; Phone Number: +903125823277; Email: onerbarut@gazi.edu.tr
      • Principal Investigator: ÖNER BARUT, Asst. Prof
  • Merkez
    • Kirşehi̇r, Merkez, Turkey, 40100
      • Kirsehir Ahi Evran University
      • Contact: ÖZGE BARUT ÇELİK, MSc; Phone Number: +905527521401; Email: ozgebarut@ahievran.edu.tr
      • Principal Investigator: Özge BARUT ÇELİK, MSc.
      • Sub-Investigator: Figen TUNCAY, Prof.
  • Çubuk
    • Ankara, Çubuk, Turkey, 06760
      • Ankara Yildirim Beyazit University
      • Contact: ERTUĞRUL ERTUĞRUL, Assoc. Prof.; Phone Number: +903129061928; Email: edemirdel@aybu.edu.tr
      • Principal Investigator: ERTUĞRUL ERTUĞRUL, Assoc. Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being diagnosed with Parkinson's disease by a qualified neurologist (diagnosed with idiopathic PD according to UK Brain Bank criteria
• Being between 1-2.5 stages according to the Hoehn and Yahr Staging Scale
• Volunteering to participate in the study
• 50 years of age or older
• Standardized Mini Mental Test score greater than 24
• Patients experiencing an on-off period are in the "on" period
• Not using deep brain stimulation or drug pump
• Ability to walk independently on level ground (Functional Ambulation 3 and above according to classification)
• Having a score of (≥2) on item 3 of the freezing while walking scale

Exclusion Criteria:

• Being any neurological or psychiatric disease other than Parkinson's disease
• Cardiovascular, vestibular or musculoskeletal disease
• Dyskinetic movements
• Having vision problems that cannot be corrected with glasses or lenses
• Hearing problems that cannot be corrected with a hearing aid
• Using an assistive device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional group; Patients in the conventional treatment group will be given 15 minutes of walking training in addition to the 45 minutes of conventional Parkinson's rehabilitation program. Patients in the conventional treatment group will be trained in flexibility (lumbar extensors, hip flexors, hamstrings, pectorals), balance (weight transfer, static balance with stress loading) coordination (rotational and bilateral activities), respiratory (thoracic expansion, respiratory control), strength (hip circumference, abdomen, back extensors), stabilization, posture (chin tuck, scapular adduction) exercises will be given and the number of repetitions will be adjusted according to patient performance. Walking training to be given to the conventional group will include walking in different directions, walking with arm swing, walking over blocks, stopping and restarting walking, and changing direction activities.	Procedure: Conventional Parkinson Rehabilitation; Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.
Experimental: Virtual reality group; Patients in the virtual reality group will be given a 45-minute conventional Parkinson's rehabilitation program similar to those in the conventional group, followed by 15 minutes of virtual reality walking training. Patients in the virtual reality group will be trained in flexibility (lumbar extensors, hip flexors, hamstrings, pectorals), balance (weight transfer, static balance with stress loading) coordination (rotational and bilateral activities), Respiratory (thoracic expansion, respiratory control), strength (hip circumference, abdomen, back extensors) stabilization, posture (chin tuck, scapular adduction) exercises will be given and the number of repetitions will be adjusted according to patient performance. Virtual reality applications increase the sense of reality in the individual with enriched virtual environments where sensory inputs are increased and provide the opportunity to perform activity training with a rich variety of tasks.	Procedure: Conventional Parkinson Rehabilitation; Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.; Device: Task-Oriented Virtual Reality Application with Crowd Simulation; Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freezing Phenomenon	The presence and severity of freezing in patients will be evaluated with the Freezing of Gait Questionnaire. It consists of six items and each item is evaluated with a 5-point Likert scale. In the scale, which was adapted into Turkish by Candan et al., the score range is 0-24 and high scores indicate that the condition associated with frostbite is poor.	Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Balance	The balance of the patients will be evaluated with the Biodex Balance System. Postural stability and fall risk will be evaluated.	Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Functional Mobility	The Timed Get Up and Go Test (TUG) will be used to assess functional mobility. The TUG, which includes walking and turning functions, has been shown to be highly reliable and valid for individuals with Parkinson's disease). The person to be tested sits on a chair at normal height. With the command "Go", the person is asked to get up from the chair and walk 3 m forward at a normal walking speed and then return and sit back on the chair. It is usually administered twice and the average time is recorded. The person is allowed to use an assistive device (if available) and this is noted.	Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Quality of Life Assessment	Quality of life will be assessed with Parkinson's Disease Questionnaire (PDQ-8) developed specifically for individuals with Parkinson's disease. This validated questionnaire consists of eight questions to assess mobility, activities of daily living, emotional well-being, disease stigma, social support, cognition, communication and physical discomfort . In the questionnaire, the status of the person in the last month is questioned. The total score is between 0 and 100, with lower scores indicating better perceived health status due to the disease.	Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Participation	In order to evaluate social participation in the study, home participation (grocery shopping, meal preparation, daily household chores, money management, etc.), social participation (hobby, going out of the house, etc.), productivity (school, work, volunteer activities, etc.), electronic A scale consisting of 43 social networks (internet use, social communication, mobile phone use, etc.), 4 subunits and a total of 18 questions will be used.	Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive functions	The Trail Making Test (TMT) will be used to assess executive functions. The TMT measures executive functions such as working memory, complex attention, planning and set switching and requires visual-spatial processing and motor skills. TMT , A and B It consists of two parts. Part A of the TMT, which is an executive function test, evaluates the processing speed based on visual scanning ability, while part B evaluates the ability to change the setup between stimulus sets and to follow the sequentiality. Cangöz et al. determined the standardized values of the test for people over 50 years of age.	Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
The activity-specific balance confidence scale	The activity-specific balance confidence scale will be used to assess the level of confidence the individual feels when performing balance-related activities of daily living. In the questionnaire consisting of 16 questions, the level of confidence felt ranges from 0% (completely insecure) to 100% (completely safe). The score obtained is divided by 16 to obtain a total score. 0-49 points indicate low functional level, 50-80 points indicate medium functional level and 81-100 points indicate high functional level. Scores below 67% indicate a fall risk in elderly individuals.	Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University
• Investigators: Study Director: Ertuğrul DEMİRDEL, Assoc. Prof., Ankara Yildirim Beyazıt University; Study Chair: Özge BARUT ÇELİK, MSc., Kirsehir Ahi Evran University; Principal Investigator: Figen TUNCAY, Prof., Kirsehir Ahi Evran University; Principal Investigator: Öner BARUT, Asst. Prof., Gazi University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; virtual reality
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: AnkaraYBÜ-VR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No