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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06940245
Enrollment
100
Registered
2025-04-23
Start date
2025-04-20
Completion date
2027-07-30
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Fall Risk Factors, Sleep

Brief summary

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.

Interventions

None listed

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
30 - second chair stand test10 days ± 3 days after the familiarization dayto 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

Secondary

MeasureTime frameDescription
Strength asessment10 days ± 3 days after the familiarization dayHandgrip Test (Kg) Flexors and Extensors of thigh muscles (Kg)
Balance test10 days ± 3 days after the familiarization daybalance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)
Sleep assessmentsleep monitoring duration: 10 days ± 3 days after the familiarization dayObjective assessment of sleep quantity and quality using the MotionWatch 8® (CamTec, USA), and sleep diary.
Sleep Hygene Index10 days ± 3 days after the familiarization dayQuestionnaire to assess the sleep hygene
Body Impedence AssessmentT1to 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.
Virtual reality (CNS Sprint)10 days ± 3 days after the familiarization dayTo assess the response time (ms)
The Pittsburgh Sleep Quality Index10 days ± 3 days after the familiarization dayQuestionnaire to assess sleep quality
Morningness-Eveningness Questionnaire10 days ± 3 days after the familiarization dayQuestionnaire to assess the chronotype
Virtual reality (VR-Brain Tracker)10 days ± 3 days after the familiarization dayEvaluation to assess visual attention through the Multiple Object Tracking paradigm.
Karolinska Sleepiness Scale10 days ± 3 days after the familiarization dayScale to assess the sleepiness
Tiredness Severity Scale10 days ± 3 days after the familiarization dayScale to assess the tiredness
SARC-F10 days ± 3 days after the familiarization dayA QUESTIONNAIRE FOR SCREENING THE RISK OF SARCOPENIA
International Physical Activity Questionnaire10 days ± 3 days after the familiarization dayQuestionnaire to assess the physical activity
BORG-CR10 scale10 days ± 3 days after the familiarization dayEFFORT PERCEPTION SCALE
Mini Nutritional Assessment10 days ± 3 days after the familiarization dayQUESTIONNAIRE TO ASSESS THE RISK OF MALNUTRITION
Nutritional diary10 days ± 3 days after the familiarization dayKeeping a food diary helps collect accurate data on participants' eating habits for scientific analysis.
Virtual reality (Visual efficiency)10 days ± 3 days after the familiarization dayTo assess the visual field

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026