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

NCT ID: NCT06390553

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional Parkinson Rehabilitation

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Task-Oriented Virtual Reality Application with Crowd Simulation

Intervention Type: DEVICE

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

Conventional Parkinson Rehabilitation

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

Conventional Parkinson Rehabilitation

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Ertuğrul Demirdel

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ertuğrul DEMİRDEL, Assoc. Prof.

Role: STUDY_DIRECTOR

Ankara Yildirim Beyazıt University

Özge BARUT ÇELİK, MSc.

Role: STUDY_CHAIR

Kirsehir Ahi Evran University

Figen TUNCAY, Prof.

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran University

Öner BARUT, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, Maltepe, Turkey (Türkiye)

Kirsehir Ahi Evran University

Kirşehi̇r, Merkez, Turkey (Türkiye)

Ankara Yildirim Beyazit University

Ankara, Çubuk, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ertuğrul DEMİRDEL, Assoc. Prof.

Role: CONTACT

edemirdel@aybu.edu.tr

+903129061928

Özge BARUT ÇELİK, MSc.

Role: CONTACT

ozgebarut@ahievran.edu.tr

+905527521401

Facility Contacts

ÖNER BARUT, Asst. Prof.

Role: primary

onerbarut@gazi.edu.tr

+903125823277

ÖZGE BARUT ÇELİK, MSc

Role: primary

ozgebarut@ahievran.edu.tr

+905527521401

ERTUĞRUL ERTUĞRUL, Assoc. Prof.

Role: primary

edemirdel@aybu.edu.tr

+903129061928

Other Identifiers

AnkaraYBÜ-VR

Identifier Type: -

Identifier Source: org_study_id