Virtual Reality and Fear of Falling in Parkinson's Disease

Study Overview
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Brief Summary
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Background: Falls are common in elderly individuals and those with neurological conditions like Parkinson's disease. Parkinson's disease causes postural instability and mobility issues that lead to falls and reduced quality of life. The fear of falling (FoF), a natural response to unstable balance, can exacerbate postural control problems. However, evaluating FoF relies primarily on subjective self-reports due to a lack of objective assessment methods. Objectives: This mixed-methods feasibility study aims to develop an objective method for assessing fear of falling during motion and walking using virtual reality. This protocol examines a range of FoF-related responses, including cognitive, neuromuscular, and postural stability factors. Methods: Parkinson's disease patients and healthy controls will complete questionnaires, movement tasks, and walking assessments in real and virtual environments where FoF can be elicited using virtual reality (VR) technology. Data from center-of-pressure measurements, electromyography, heart rate monitoring, motion capture, and usability metrics will evaluate the method's acceptability and safety. Semi-structured interviews will gather participants' and researchers' experiences of the protocol. Discussion: This method may allow accurate assessment of how FoF impacts movement by measuring cognitive, neuromuscular, and postural responses during gait and motion. Virtual environments reproduce real-life scenarios that trigger FoF. Rigorously assessing FoF with this approach could demonstrate its ability to quantify the effects of FoF on movement. Conclusions: This protocol aims to improve FoF assessment by evaluating multiple responses during movement in virtual environments. It addresses current measures' limitations. A feasibility study will identify areas for improvement specific to Parkinson's disease. Successful validation could transform how FoF is evaluated and managed.

Official Title
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Virtual Reality in Examining the Effect of Fear of Falling on Postural Stability in Healthy Adults and Individuals With Parkinson's Disease

Conditions
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Parkinson, Parkinson Disease, Parkinson's Disease and Parkinsonism

Intervention / Treatment
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* Diagnostic Test: Virtual reality
* Diagnostic Test: Electroencephalogram
* Diagnostic Test: Electromyography
* Diagnostic Test: Motion Capture system
* Diagnostic Test: Polar H10 Heart Sensor
* Diagnostic Test: Inertial measurement Unite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years old. Participants diagnosed with Parkinson's disease by a neurologist, regardless the type. Modified Hoehn and Yahr stages I to III. Able to follow instructions and understand questions. Able to walk independently and without walking aids. People who experience excessive fear of falling and fear of movement. Able to communicate verbally. Stable use of Parkinson's Disease or other comorbidities medications. Exclusion Criteria: Impaired vision and hearing. Unstable medical condition. Co-existing neurological or orthopedic conditions that may limit mobility and affect participation. Dizziness, vertigo, headache, and motion-sickness. Cognition impairments. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Adults<br>Adults over 18 years old | Diagnostic Test: Virtual reality<br>* Virtual environment that triggers fear of falling<br>Diagnostic Test: Electroencephalogram<br>* Detect brain waves in response to fear of falling<br>Diagnostic Test: Electromyography<br>* Measures muscle activity and response to fear of falling<br>Diagnostic Test: Motion Capture system<br>* Measures postural and gait responses to fear of falling<br>Diagnostic Test: Polar H10 Heart Sensor<br>* Heart rate monitor<br>Diagnostic Test: Inertial measurement Unite<br>* Measure Postural sway<br>|
| Parkinson Disease<br>adults with Parkinson's Disease at stage I to III Hoehn and Yahr scale | Diagnostic Test: Virtual reality<br>* Virtual environment that triggers fear of falling<br>Diagnostic Test: Electroencephalogram<br>* Detect brain waves in response to fear of falling<br>Diagnostic Test: Electromyography<br>* Measures muscle activity and response to fear of falling<br>Diagnostic Test: Motion Capture system<br>* Measures postural and gait responses to fear of falling<br>Diagnostic Test: Polar H10 Heart Sensor<br>* Heart rate monitor<br>Diagnostic Test: Inertial measurement Unite<br>* Measure Postural sway<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Control | Movement control throughout the movement scenario will be assessed using a Qualisys motion capture system (MCS). | 5 minutes | 
| Balance Assessment | Force platforms will measure the center of pressure (COP) displacement during the movement scenario. | 5 minutes | 
| Postural Sway | A postural Inertial Measurement Unit (IMU) will be placed over the projected center of mass located at the 4th lumbar vertebra to evaluate postural sway. | 5 minutes | 
| EEG Monitoring | The electroencephalogram (EEG) will be used to monitor the neuromuscular system's reaction to fear throughout the movement scenario. power in alpha and beta frequency bands will be recorded. | 5 minutes | 
| EMG Monitoring | The electromyography (EMG) will be employed to monitor the neuromuscular system's reaction to fear throughout the movement scenario. Muscle activation of lower limb muscles such as tibialis anterior and quadriceps will be recorded by surface EMG. | 5 minutes | 
| Heart Rate Monitoring | The unit of measurement for heart rate monitoring is typically beats per minute (BPM). The Polar H10 heart rate sensor will be used in to measure the electrical signals produced by the heart and provides continuous and accurate heart rate readings in BPM. | 5 minutes | 
| Heart Rate Variability Monitoring | The Polar H10 heart rate sensor will provide Heart Rate Variability (HRV) measurements using its RR recording feature. Specifically, the Polar H10 sensor can calculate the root mean square of successive differences (RMSSD) and the standard deviation of normal-to-normal intervals (SDNN) as measures of HRV. | 5 minutes | 
| Suitability Evaluation | the Suitability Evaluation Questionnaire (SEQ) is the SEQ Suitability Evaluation Questionnaire for Virtual Rehabilitation Systems. The range of scores is 0 to 100, with higher scores indicating a better outcome. The SEQ is scored by summing the responses to the 14 items. The items are scored on a 7-point Likert scale, with 1 = strongly disagree and 7 = strongly agree. The total score can range from 0 to 98. A higher score on the SEQ indicates that the VR system is perceived as being more user-friendly, enjoyable, and safe. This suggests that the patient is more likely to use the VR system and to benefit from it. | 30 minutes | 
| Sense of Presence | The iGroup Presence Questionnaire (IPQ) has a range of scores is 0 to 6, with higher scores indicating a better outcome. The IPQ is scored by summing the responses to the 14 items. The items are scored on a 7-point Likert scale, with 1 = disagree strongly and 7 = agree strongly. The total score can range from 0 to 98. A higher score on the IPQ indicates that the user feels more present in the Virtual environment (VE). This suggests that the VE is more immersive and engaging, and that the user is more likely to be absorbed in the experience. | 30 minutes | 
| Effort | The Borg Rated Perceived Exertion (RPE) scale will record effort during the session. The Borg Rated Perceived Exertion (RPE) Scale: Range 0-10, higher scores indicate greater perceived exertion. | 30 minutes | 
| Fear Experience Assessment | Full scale name: Falls Efficacy Scale - International (FES-I). Range of scores: 0 to 100. The FES-I is a 16-item self-report questionnaire that measures the fear of falling in older adults. The items are scored on a 4-point Likert scale, with 1 = not at all concerned and 4 = very concerned. The total score can range from 0 to 64. A higher score on the FES-I indicates that the individual has a greater fear of falling. This can have a negative impact on their quality of life, as they may avoid activities that they enjoy or need to do, such as going out shopping or walking around the neighborhood. | 30 minutes | 
| Adverse events | any adverse events during the procedure and after effects will be documented. Number of participants reporting adverse events as per study protocol | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Falling Assessment | Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I). | 45 minutes | 
| Cognition Assessment | Montreal Cognitive Assessment (MoCA) is a brief, 30-item cognitive screening test that is used to assess a person's cognitive abilities. Montreal Cognitive Assessment has a minimum value of 0 and maximum value of 3 with Higher score indicates better outcome. A score of 26 or higher is considered normal, while a score of 25 or lower may indicate cognitive impairment. | 45 minutes | 
| Depression Assessment | Hamilton Depression Rating Scale (HAM-D) will be used to assess depression level. Minimum value is 0 and the maximum value is 52. Lower scores indicate better outcome. The HAM-D is a 17-item clinician-rated scale that is used to assess the severity of depression. The scale was developed by Max Hamilton in 1960 and has been used in a wide range of studies to assess depression. The HAM-D covers a range of symptoms of depression, including depressed mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each item is scored on a 5-point scale, with 0 = absent and 4 = severe. The total score can range from 0 to 52, with a higher score indicating more severe depression. | 45 minutes | 
| Anxiety Assessment | Hamilton Anxiety Rating Scale will be used to assess level of anxiety. the Minimum value is 0 and Maximum value is 56. Lower score indicates better outcome. It is a 14-item clinician-rated scale that is used to assess the severity of anxiety. The scale was developed by Max Hamilton in 1959 and has been used in a wide range of studies to assess anxiety. It covers a range of symptoms of anxiety, including anxious mood, tension, fears, insomnia, intellectual, somatic (muscular), somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic symptoms, and behavior at interview. Each item is scored on a 4-point scale, with 0 = absent and 4 = severe. The total score can range from 0 to 56, with a higher score indicating more severe anxiety. | 45 minutes | 
| Participation Assessment | Participation levels will be assessed using the World Health Organization Disability Assessment Schedule 2.0. the Minimum value is 0 and Maximum value is 100. Lower score indicates better outcome. The WHODAS 2.0 is a 12-item self-report questionnaire that is used to assess the impact of a health condition on an individual's functioning. The items are scored on a 5-point scale, with 0 = no difficulty and 4 = extreme difficulty. The total score can range from 0 to 100, with a lower score indicating less disability. The WHODAS 2.0 covers six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. The scale was developed by the World Health Organization (WHO) and is based on the International Classification of Functioning, Disability and Health (ICF). | 45 minutes | 
| Health-related Quality of Life Assessment | Health-related quality of life will be evaluated using the Parkinson's Disease Questionnaire 39 (PDQ-39). Parkinson's Disease Questionnaire 39 has a Minimum value of 0 and Maximum value of 100. Lower score indicates better outcome. The PDQ-39 is a 39-item self-report questionnaire that is used to assess the impact of Parkinson's disease (PD) on an individual's quality of life. The items are scored on a 5-point scale, with 0 = no problem and 4 = severe problem. The total score can range from 0 to 100, with a lower score indicating better quality of life. | 45 minutes |