Use of Virtual Reality for the Assessment of Attentional and Reaction Abilities for Fall Risk Evaluation

Motor and Cognitive Abilities in Relation to Fall Risk: Use of Virtual Reality for the Assessment of Attentional and Reaction Capacities

Aging is a condition characterized by a general decline in physical and cognitive performance, however its effects on various functions are still controversial. These changes lead to an increased risk of injuries, particularly due to falls. According to the World Health Organization (WHO) report, 28-35% of individuals aged over 65 experience a fall each year, and this percentage increases with age. For this reason, preventing falls among the elderly is undeniably one of the most critical public health issues in today's aging society. Nowadays, it is widely demonstrated that the loss of muscle strength and mass, along with decreased balance, significantly increases the risk of falls. However, with aging, numerous other changes occur that contribute to an increased risk of falls, such as a decline in cognitive function, including attention, reaction capabilities and memory, as well as other factors that worsen the quality of life, such as insufficient sleep or nutrition. According to WHO estimates, by 2030, the number of injuries due to falls will double. Therefore, it is of great importance to understand and analyze the factors contributing to falls among older adults in everyday life. For this reason, the principal aim of this study was to evaluate the correlation between the fall index and the Visual Attention, Reaction Time and visual field using the technologies of Virtual Reality (VR). Since aging brigs changes in different aspect, the secondary objectives aim to study the correlation also with i) sleep quantity and quality parameters, ii) risk of malnutrition, and iii) physical condition, muscle conditions and strength in order to have a comprehensive understanding of the factors that most contribute to the risk of falls. In addition to these objectives, the correlation between acute sleep deprivation and the risk of falls will also be analyzed, in order to understand how inadequate sleep quantity can impact injuries in the elderly.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep; Aging; Fall Risk Factors

• Study Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A minimum of 100 subjects aged 60 years or older will be recruited, but recruitment will continue until enough subjects are identified to reach the predetermined number for the second study. The subjects are chosen on the basis of the following inclusion and exclusion criteria

Description

Inclusion Criteria:

• Male or female, of any ethnicity;
• Age ≥ 60 years;
• Cognitively intact;
• Autonomous ambulation;
• Signed and accepted informed consent to participate in all procedures required for the study.

Exclusion Criteria:

• Body Mass Index > 40.0;
• History of epileptic episodes;
• Bone fractures in the last 6 months;
• Previous surgical treatments for orthopedic conditions performed in the six months prior to study inclusion;
• Use of medications that affect motor coordination, balance, and bone and muscle metabolism;
• Conditions that, despite autonomous ambulation, influence fall risk (e.g., orthopedic, rheumatologic, or neurological conditions);
• Carriers of pacemakers and mechanical implants.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 - second chair stand test	to assess the leg strength and endurance in older adults. Being in a specific sitting position on a chair, the test consists of getting up and sitting down as many times as possible in 30 seconds	10 days ± 3 days after the familiarization day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virtual reality (VR-Brain Tracker)	Evaluation to assess visual attention through the Multiple Object Tracking paradigm.	10 days ± 3 days after the familiarization day
Strength asessment	Handgrip Test (Kg) Flexors and Extensors of thigh muscles (Kg)	10 days ± 3 days after the familiarization day
Balance test	balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)	10 days ± 3 days after the familiarization day
Sleep assessment	Objective assessment of sleep quantity and quality using the MotionWatch 8® (CamTec, USA), and sleep diary.	sleep monitoring duration: 10 days ± 3 days after the familiarization day
Sleep Hygene Index	Questionnaire to assess the sleep hygene	10 days ± 3 days after the familiarization day
Body Impedence Assessment	to assess body composition by measuring the resistance of electrical flow through the body. It helps estimate parameters like body fat percentage, muscle mass, and water content. BIA is commonly used in health and fitness settings to monitor changes in body composition, guide nutritional and fitness plans, and assess overall health.	T1
Virtual reality (CNS Sprint)	To assess the response time (ms)	10 days ± 3 days after the familiarization day
Virtual reality (Visual efficiency)	To assess the visual field	10 days ± 3 days after the familiarization day
The Pittsburgh Sleep Quality Index	Questionnaire to assess sleep quality	10 days ± 3 days after the familiarization day
Morningness-Eveningness Questionnaire	Questionnaire to assess the chronotype	10 days ± 3 days after the familiarization day
Karolinska Sleepiness Scale	Scale to assess the sleepiness	10 days ± 3 days after the familiarization day
Tiredness Severity Scale	Scale to assess the tiredness	10 days ± 3 days after the familiarization day
SARC-F	A QUESTIONNAIRE FOR SCREENING THE RISK OF SARCOPENIA	10 days ± 3 days after the familiarization day
International Physical Activity Questionnaire	Questionnaire to assess the physical activity	10 days ± 3 days after the familiarization day
BORG-CR10 scale	EFFORT PERCEPTION SCALE	10 days ± 3 days after the familiarization day
Mini Nutritional Assessment	QUESTIONNAIRE TO ASSESS THE RISK OF MALNUTRITION	10 days ± 3 days after the familiarization day
Nutritional diary	Keeping a food diary helps collect accurate data on participants' eating habits for scientific analysis.	10 days ± 3 days after the familiarization day

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: VR&RISKofFALL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No