Virtual Reality and Fear of Falling in Parkinson's Disease
NCT ID: NCT05931692
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2023-07-17
2026-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Individuals without Parkinson's disease
People over 40 years old
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
Parkinson Disease
People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Ahram Canadian University
OTHER
Responsible Party
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Yasmine Gomaa
Lecturer of Physcial Therapy for Neuromuscular Disorders
Principal Investigators
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Yasmine S Gomaa, Ph.d
Role: PRINCIPAL_INVESTIGATOR
Kafrelsheikh University
Locations
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Human Mechatronics Lab, Ain Shams Virtual Hospital, Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Gomaa YS, Awad MI, Emara T, Elbokl A, Al-Yahya E, ElMeligie MM. 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 protocol. BMJ Open. 2024 May 1;14(5):e080592. doi: 10.1136/bmjopen-2023-080592.
Other Identifiers
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P.T/ NEUR /3/2023/46
Identifier Type: -
Identifier Source: org_study_id
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