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

NCT06390553 | Not Yet Recruiting

• 1 other identifier: AnkaraYBÜ-VR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson's Disease; Freezing of Gait

Keywords

virtual reality; rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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 Arms (2)

Conventional group

ACTIVE COMPARATOR

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

Virtual reality group

EXPERIMENTAL

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.

Device: Task-Oriented Virtual Reality Application with Crowd Simulation; Procedure: Conventional Parkinson Rehabilitation

Interventions

Task-Oriented Virtual Reality Application with Crowd Simulation DEVICE

Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.

Virtual reality group

Conventional Parkinson Rehabilitation PROCEDURE

Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.

Conventional group; Virtual reality group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (3)

Gazi University

Ankara, Maltepe, 06570, Turkey (Türkiye)

Location

Kirsehir Ahi Evran University

Kirşehi̇r, Merkez, 40100, Turkey (Türkiye)

Location

Ankara Yildirim Beyazit University

Ankara, Çubuk, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ertuğrul DEMİRDEL, Assoc. Prof.

  Ankara Yildirim Beyazıt University

  STUDY DIRECTOR

• Özge BARUT ÇELİK, MSc.

  Kirsehir Ahi Evran University

  STUDY CHAIR

• Figen TUNCAY, Prof.

  Kirsehir Ahi Evran University

  PRINCIPAL INVESTIGATOR

• Öner BARUT, Asst. Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ertuğrul DEMİRDEL, Assoc. Prof.

CONTACT

+903129061928; edemirdel@aybu.edu.tr

Özge BARUT ÇELİK, MSc.

CONTACT

+905527521401; ozgebarut@ahievran.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 30, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

TU (3)