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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390553
• Other study ID #: AnkaraYBÜ-VR
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Ankara Yildirim Beyazit University
• Contact: Ertugrul DEMIRDEL, Assoc. Prof.
• Phone: +903129061928
• Email: edemirdel[@]aybu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Procedure:
• Conventional Parkinson Rehabilitation
Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara	Çubuk
Turkey	Gazi University	Ankara	Maltepe
Turkey	Kirsehir Ahi Evran University	Kirsehi?r	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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