An interventional study of Task-Oriented Virtual Reality Application with Crowd Simulation and Conventional Parkinson Rehabilitation in Parkinson's Disease and Freezing of Gait, sponsored by Ankara Yildirim Beyazıt University. Status unknown at 3 sites in Turkey (Türkiye). Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment
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.
4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
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
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
Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.
Patients will be treated 4 days a week for 8 weeks in accordance with their assigned group.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
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.
Time frame: 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.
Time frame: Day 1-Study Day Visit; 8-week Follow-up Visit; 3-month Follow-up Visit
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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