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

NCT06940245 | Not Yet Recruiting DMC

• 1 other identifier: VR&RISKofFALL
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Virtual reality (VR-Brain Tracker)

  10 days ± 3 days after the familiarization day

• Strength asessment

  10 days ± 3 days after the familiarization day

• Balance test

  10 days ± 3 days after the familiarization day

• Sleep assessment

  sleep monitoring duration: 10 days ± 3 days after the familiarization day

• Sleep Hygene Index

  10 days ± 3 days after the familiarization day

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Body Mass Index \> 40.0;
• History of epileptic episodes;
• Bone fractures in the last 6 months;
• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 23, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04