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

NCT ID: NCT06940245

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-20
• Study Completion Date: 2027-07-30

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.

Conditions

Aging; Fall Risk Factors; Sleep

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

VR&RISKofFALL

Identifier Type: -

Identifier Source: org_study_id