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Clinical Trials/NCT05931692
NCT05931692
Recruiting
Not Applicable

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

Ahram Canadian University1 site in 1 country15 target enrollmentJuly 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson
Sponsor
Ahram Canadian University
Enrollment
15
Locations
1
Primary Endpoint
Movement Control
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2023
End Date
January 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yasmine Gomaa

Lecturer of Physcial Therapy for Neuromuscular Disorders

Ahram Canadian University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Movement Control

Time Frame: 5 minutes

Movement control throughout the movement scenario will be assessed using a Qualisys motion capture system (MCS).

Postural Sway

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 5 minutes

Force platforms will measure the center of pressure (COP) displacement during the movement scenario.

Secondary Outcomes

  • 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)

Study Sites (1)

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