Clinical trial NCT05931692: Virtual Reality and Fear of Falling in Parkinson's Disease
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson
Parkinson Disease
Parkinson's Disease and Parkinsonism
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2023-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups of participants, who age 40 or older, will be involved in this study. Each group will have from 10 to 30 participants. The first group will include a group of individuals without Parkinson's disease and the second group will include people with Parkinson's disease, both will be screened for eligibility. Participants who meet the inclusion criteria will go through the planned assessment procedure.

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.


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.

Primary outcomes:
measure: Movement Control
timeFrame: 5 minutes
measure: Balance Assessment
timeFrame: 5 minutes
measure: Postural Sway
timeFrame: 5 minutes
measure: EEG Monitoring
timeFrame: 5 minutes
measure: EMG Monitoring
timeFrame: 5 minutes
measure: Heart Rate Monitoring
timeFrame: 5 minutes
measure: Suitability Evaluation
timeFrame: 30 minutes
measure: Sense of Presence
timeFrame: 30 minutes
measure: Effort
timeFrame: 30 minutes
measure: Adverse events
timeFrame: 30 minutes
Secondary outcomes:
measure: Fear of Falling Assessment
timeFrame: 45 minutes
measure: Cognition Assessment
timeFrame: 45 minutes
measure: Depression Assessment
timeFrame: 45 minutes
measure: Anxiety Assessment
timeFrame: 45 minutes
measure: Participation Assessment
timeFrame: 45 minutes
measure: Health-related Quality of Life Assessment
timeFrame: 45 minutes
measure: Balance confidence
timeFrame: 10 minutes
measure: Combined Balance assessment
timeFrame: 15 minutes
Other outcomes:
measure: Qualitative Data
timeFrame: 45 minutes
Locations:
city: Cairo
country: Egypt
facility: Human Mechatronics Lab, Ain Shams Virtual Hospital, Ain Shams University
Study officials:
affiliation: Kafrelsheikh University
name: Yasmine S Gomaa, Ph.d
role: PRINCIPAL_INVESTIGATOR
References: