Virtual Reality and Fear of Falling in Parkinson's Disease
- Conditions
- ParkinsonParkinson's Disease and ParkinsonismParkinson Disease
- Interventions
- Diagnostic Test: Virtual realityDiagnostic Test: ElectroencephalogramDiagnostic Test: ElectromyographyDiagnostic Test: Motion Capture systemDiagnostic Test: Polar H10 Heart SensorDiagnostic Test: Inertial measurement Unite
- Registration Number
- NCT05931692
- Lead Sponsor
- Ahram Canadian University
- Brief Summary
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: Individuals without and with Parkinson's disease 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- People ≥ 40 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson Disease Polar H10 Heart Sensor People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale Parkinson Disease Electroencephalogram People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale Parkinson Disease Motion Capture system People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale Parkinson Disease Inertial measurement Unite People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale Individuals without Parkinson's disease Inertial measurement Unite People over 40 years old Individuals without Parkinson's disease Electromyography People over 40 years old Individuals without Parkinson's disease Polar H10 Heart Sensor People over 40 years old Individuals without Parkinson's disease Electroencephalogram People over 40 years old Individuals without Parkinson's disease Virtual reality People over 40 years old Parkinson Disease Virtual reality People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale Parkinson Disease Electromyography People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale Individuals without Parkinson's disease Motion Capture system People over 40 years old
- Primary Outcome Measures
Name Time Method Movement Control 5 minutes Movement control throughout the movement scenario will be assessed using a Qualisys motion capture system (MCS).
Postural Sway 5 minutes 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.
EEG Monitoring 5 minutes 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.
EMG Monitoring 5 minutes 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.
Suitability Evaluation 30 minutes 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.
Adverse events 30 minutes any adverse events during the procedure and after effects will be documented. Number of participants reporting adverse events as per study protocol
Heart Rate Monitoring 5 minutes 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.
Sense of Presence 30 minutes 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.
Effort 30 minutes 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.
Balance Assessment 5 minutes Force platforms will measure the center of pressure (COP) displacement during the movement scenario.
- Secondary Outcome Measures
Name Time Method Cognition Assessment 45 minutes 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.
Balance confidence 10 minutes Balance confidence will be evaluated using Activity-specific Balance Confidence scale (ABC scale). Which is a self-administered scale to indicate the level of confidence the person has in doing the activity without losing his/her balance. The ABC is an 16 point scale and ratings should consist of whole numbers (0 to 100) for each item. Total the ratings and divide by 16 to get each subject's ABC score.
Fear of Falling Assessment 45 minutes Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I).
Anxiety Assessment 45 minutes 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.
Participation Assessment 45 minutes 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).
Depression Assessment 45 minutes 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.
Combined Balance assessment 15 minutes Mini Balance Evaluation System Test (mini-BESTest) will be used and it assesses 4 domains: Anticipatory postural adjustments, Reactive postural control, Sensory orientation, and Dynamic gait. The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" indicates the lowest level of function and "2" the highest level of function.
Health-related Quality of Life Assessment 45 minutes 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.
Trial Locations
- Locations (1)
Human Mechatronics Lab, Ain Shams Virtual Hospital, Ain Shams University
🇪🇬Cairo, Egypt