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NCT Number: NCT06940245

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

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.

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Key information

Conditions

Aging Fall Risk Factors Sleep

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 30 - second chair stand test

    Time frame: 10 days ± 3 days after the familiarization day

    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

Secondary outcomes

  1. Virtual reality (VR-Brain Tracker)

    Time frame: 10 days ± 3 days after the familiarization day

    Evaluation to assess visual attention through the Multiple Object Tracking paradigm.

  2. Strength asessment

    Time frame: 10 days ± 3 days after the familiarization day

    Handgrip Test (Kg) Flexors and Extensors of thigh muscles (Kg)

  3. Balance test

    Time frame: 10 days ± 3 days after the familiarization day

    balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)

  4. Sleep assessment

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

    Objective assessment of sleep quantity and quality using the MotionWatch 8® (CamTec, USA), and sleep diary.

  5. Sleep Hygene Index

    Time frame: 10 days ± 3 days after the familiarization day

    Questionnaire to assess the sleep hygene

  6. Body Impedence Assessment

    Time frame: T1

    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.

  7. Virtual reality (CNS Sprint)

    Time frame: 10 days ± 3 days after the familiarization day

    To assess the response time (ms)

  8. Virtual reality (Visual efficiency)

    Time frame: 10 days ± 3 days after the familiarization day

    To assess the visual field

  9. The Pittsburgh Sleep Quality Index

    Time frame: 10 days ± 3 days after the familiarization day

    Questionnaire to assess sleep quality

  10. Morningness-Eveningness Questionnaire

    Time frame: 10 days ± 3 days after the familiarization day

    Questionnaire to assess the chronotype

  11. Karolinska Sleepiness Scale

    Time frame: 10 days ± 3 days after the familiarization day

    Scale to assess the sleepiness

  12. Tiredness Severity Scale

    Time frame: 10 days ± 3 days after the familiarization day

    Scale to assess the tiredness

  13. SARC-F

    Time frame: 10 days ± 3 days after the familiarization day

    A QUESTIONNAIRE FOR SCREENING THE RISK OF SARCOPENIA

  14. International Physical Activity Questionnaire

    Time frame: 10 days ± 3 days after the familiarization day

    Questionnaire to assess the physical activity

  15. BORG-CR10 scale

    Time frame: 10 days ± 3 days after the familiarization day

    EFFORT PERCEPTION SCALE

  16. Mini Nutritional Assessment

    Time frame: 10 days ± 3 days after the familiarization day

    QUESTIONNAIRE TO ASSESS THE RISK OF MALNUTRITION

  17. Nutritional diary

    Time frame: 10 days ± 3 days after the familiarization day

    Keeping a food diary helps collect accurate data on participants' eating habits for scientific analysis.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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