Virtual Reality and Fear of Falling in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931692
• Other study ID #: P.T/ NEUR /3/2023/46
• Status: Recruiting
• Start date: July 17, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: Ahram Canadian University
• Contact: Yasmine S Gomaa, Ph.d
• Phone: +201001590520
• Email: yasmeen_gomaa[@]pt.kfs.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders

Intervention

Diagnostic Test:
• Virtual reality
Virtual environment that triggers fear of falling
• Electroencephalogram
Detect brain waves in response to fear of falling
• Electromyography
Measures muscle activity and response to fear of falling
• Motion Capture system
Measures postural and gait responses to fear of falling
• Polar H10 Heart Sensor
Heart rate monitor
• Inertial measurement Unite
Measure Postural sway

Locations

Country	Name	City	State
Egypt	Human Mechatronics Lab, Ain Shams Virtual Hospital, Ain Shams University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ahram Canadian University	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Data	Interviews with participants and a focus group for research assistants will explore perceived barriers and facilitators, including feasibility, acceptability, usability, and safety, for implementing the assessment. Face-to-face semi-structured interviews for participants will take place at Ain Shams University Hospital, while an online meeting will be arranged for the focus group.	45 minutes
Primary	Movement Control	Movement control throughout the movement scenario will be assessed using a Qualisys motion capture system (MCS).	5 minutes
Primary	Balance Assessment	Force platforms will measure the center of pressure (COP) displacement during the movement scenario.	5 minutes
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Fear of Falling Assessment	Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I).	45 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Balance confidence	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.	10 minutes
Secondary	Combined Balance assessment	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.	15 minutes