Clinical trial NCT06940245: Use of Virtual Reality for the Assessment of Attentional and Reaction Abilities for Fall Risk Evaluation
Official title: Motor and Cognitive Abilities in Relation to Fall Risk: Use of Virtual Reality for the Assessment of Attentional and Reaction Capacities
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aging
Fall Risk Factors
Sleep
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 30 - second chair stand test
timeFrame: 10 days ± 3 days after the familiarization day
Secondary outcomes:
measure: Virtual reality (VR-Brain Tracker)
timeFrame: 10 days ± 3 days after the familiarization day
measure: Strength asessment
timeFrame: 10 days ± 3 days after the familiarization day
measure: Balance test
timeFrame: 10 days ± 3 days after the familiarization day
measure: Sleep assessment
timeFrame: sleep monitoring duration: 10 days ± 3 days after the familiarization day
measure: Sleep Hygene Index
timeFrame: 10 days ± 3 days after the familiarization day
measure: Body Impedence Assessment
timeFrame: T1
measure: Virtual reality (CNS Sprint)
timeFrame: 10 days ± 3 days after the familiarization day
measure: Virtual reality (Visual efficiency)
timeFrame: 10 days ± 3 days after the familiarization day
measure: The Pittsburgh Sleep Quality Index
timeFrame: 10 days ± 3 days after the familiarization day
measure: Morningness-Eveningness Questionnaire
timeFrame: 10 days ± 3 days after the familiarization day
measure: Karolinska Sleepiness Scale
timeFrame: 10 days ± 3 days after the familiarization day
measure: Tiredness Severity Scale
timeFrame: 10 days ± 3 days after the familiarization day
measure: SARC-F
timeFrame: 10 days ± 3 days after the familiarization day
measure: International Physical Activity Questionnaire
timeFrame: 10 days ± 3 days after the familiarization day
measure: BORG-CR10 scale
timeFrame: 10 days ± 3 days after the familiarization day
measure: Mini Nutritional Assessment
timeFrame: 10 days ± 3 days after the familiarization day
measure: Nutritional diary
timeFrame: 10 days ± 3 days after the familiarization day
Other outcomes:
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