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Clinical Trials/NCT06390553
NCT06390553
Not yet recruiting
Not Applicable

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

Ankara Yildirim Beyazıt University3 sites in 1 country20 target enrollmentAugust 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Ankara Yildirim Beyazıt University
Enrollment
20
Locations
3
Primary Endpoint
Freezing Phenomenon
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2024
End Date
April 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ankara Yildirim Beyazıt University
Responsible Party
Principal Investigator
Principal Investigator

Ertuğrul Demirdel

Assoc. Prof.

Ankara Yildirim Beyazıt University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Freezing Phenomenon

Time Frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit

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.

Functional Mobility

Time Frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit

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.

Balance

Time Frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit

The balance of the patients will be evaluated with the Biodex Balance System. Postural stability and fall risk will be evaluated.

Participation

Time Frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit

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.

Quality of Life Assessment

Time Frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit

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.

Secondary Outcomes

  • Executive functions(Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit)
  • The activity-specific balance confidence scale(Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit)

Study Sites (3)

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