The Role of Virtual Reality in Examining the Effect of Fear of Falling (FOF) on Postural Stability in Individuals Without and With Parkinson's Disease in Egypt: A Mixed Methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Movement Control
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Movement Control
时间窗: 5 minutes
Movement control throughout the movement scenario will be assessed using a Qualisys motion capture system (MCS).
Postural Sway
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 5 minutes
Force platforms will measure the center of pressure (COP) displacement during the movement scenario.
次要结局
- Cognition Assessment(45 minutes)
- Balance confidence(10 minutes)
- Fear of Falling Assessment(45 minutes)
- Anxiety Assessment(45 minutes)
- Participation Assessment(45 minutes)
- Depression Assessment(45 minutes)
- Combined Balance assessment(15 minutes)
- Health-related Quality of Life Assessment(45 minutes)
研究者
Yasmine Gomaa
Lecturer of Physcial Therapy for Neuromuscular Disorders
Ahram Canadian University