Parkinson's DiseaseNCT06390553
Effect of Virtual Reality on Freezing Phenomenon, Balance, Functional Mobility, Participation in Parkinson's Patients
A study testing Task-Oriented Virtual Reality Application with Crowd Simulation and Conventional Parkinson Rehabilitation in people with Parkinson's Disease and Freezing of Gait, run by Ankara Yildirim Beyazıt University at 3 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease, Freezing of Gait
- What is being tested?
- Task-Oriented Virtual Reality Application with Crowd Simulation and Conventional Parkinson Rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- Aug 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Gazi University
Ankara, Maltepe, 06570
ÖNER BARUT, Asst. Prof., +903125823277, onerbarut@gazi.edu.tr
ÖNER BARUT, Asst. Prof
Ankara Yildirim Beyazit University
Ankara, Çubuk, 06760
ERTUĞRUL ERTUĞRUL, Assoc. Prof., +903129061928, edemirdel@aybu.edu.tr
ERTUĞRUL ERTUĞRUL, Assoc. Prof
Kirsehir Ahi Evran University
Kirşehi̇r, Merkez, 40100
ÖZGE BARUT ÇELİK, MSc, +905527521401, ozgebarut@ahievran.edu.tr
Özge BARUT ÇELİK, MSc.
About this study
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
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
- Being tested
- Task-Oriented Virtual Reality Application with Crowd Simulation, Conventional Parkinson Rehabilitation
- Keywords
- virtual reality, rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-Oriented Virtual Reality Application with Crowd SimulationDevice
Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.
Conventional Parkinson RehabilitationProcedure or surgery
Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Task-Oriented Virtual Reality Application with Crowd Simulation; Procedure: Conventional Parkinson Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Secondary outcomes (2)
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.
Measured: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
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.
Measured: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertuğrul Demirdel, Ankara Yildirim Beyazıt University
- Investigators
- Ertuğrul DEMİRDEL, Assoc. Prof., Study director, Ankara Yildirim Beyazıt UniversityÖzge BARUT ÇELİK, MSc., Study chair, Kirsehir Ahi Evran UniversitesiFigen TUNCAY, Prof., Principal investigator, Kirsehir Ahi Evran UniversitesiÖner BARUT, Asst. Prof., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390553
- Sponsor's protocol ID
- AnkaraYBÜ-VR
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06390553
- Acronym / sponsor ID
- AnkaraYBÜ-VR
- Conditions
- Parkinson's Disease, Freezing of Gait
- Keywords
- virtual reality, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Procedure: Conventional Parkinson RehabilitationPatients 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. |
| Virtual reality group | Experimental | Device: Task-Oriented Virtual Reality Application with Crowd Simulation, Procedure: Conventional Parkinson RehabilitationPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-Oriented Virtual Reality Application with Crowd SimulationPatients will be treated 4 days a week for 8 weeks in accordance with their assigned group. | Device | Virtual reality group |
| Conventional Parkinson RehabilitationPatients will be treated 4 days a week for 8 weeks in accordance with their assigned group. | Procedure or surgery | Conventional group, Virtual reality group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Executive functions
Time frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
The activity-specific balance confidence scale
Time frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ertuğrul DEMİRDEL, Assoc. Prof. study director
Ankara Yildirim Beyazıt University
Özge BARUT ÇELİK, MSc. study chair
Kirsehir Ahi Evran Universitesi
Figen TUNCAY, Prof. principal investigator
Kirsehir Ahi Evran Universitesi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-Oriented Virtual Reality Application with Crowd Simulation and Conventional Parkinson Rehabilitation in people with Parkinson's Disease and Freezing of Gait, run by Ankara Yildirim Beyazıt University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ertuğrul DEMİRDEL, Assoc. Prof. (+903129061928, edemirdel@aybu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freezing Phenomenon (time frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.