Clinical trial NCT06390553: Effect of Virtual Reality on Freezing Phenomenon, Balance, Functional Mobility, Participation in Parkinson's Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Freezing of Gait
Keywords: virtual reality
rehabilitation
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Freezing Phenomenon
timeFrame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
measure: Balance
timeFrame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
measure: Functional Mobility
timeFrame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
measure: Quality of Life Assessment
timeFrame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
measure: Participation
timeFrame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Secondary outcomes:
measure: Executive functions
timeFrame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
measure: The activity-specific balance confidence scale
timeFrame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Maltepe
city: Kirşehi̇r
country: Turkey
facility: Kirsehir Ahi Evran University
state: Merkez
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
state: Çubuk
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Ertuğrul DEMİRDEL, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Kirsehir Ahi Evran University
name: Özge BARUT ÇELİK, MSc.
role: STUDY_CHAIR
affiliation: Kirsehir Ahi Evran University
name: Figen TUNCAY, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Öner BARUT, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: