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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

June 15, 2023

Completed

20 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed

12 days until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed

Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

June 15, 2023

Last Update Submit

April 25, 2024

Conditions

Parkinson Parkinson Disease Parkinson's Disease and Parkinsonism

Outcome Measures

Primary Outcomes (10)

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
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
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 Outcomes (8)

Fear of Falling Assessment
45 minutes
Cognition Assessment
45 minutes
Depression Assessment
45 minutes
Anxiety Assessment
45 minutes
Participation Assessment
45 minutes
+3 more secondary outcomes

Other Outcomes (1)

Qualitative Data
45 minutes

Study Arms (2)

Individuals without Parkinson's disease

People over 40 years old

Diagnostic Test: Virtual realityDiagnostic Test: ElectroencephalogramDiagnostic Test: ElectromyographyDiagnostic Test: Motion Capture systemDiagnostic Test: Polar H10 Heart SensorDiagnostic Test: Inertial measurement Unite

Parkinson Disease

People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale