AgingNCT06940245
Use of Virtual Reality for the Assessment of Attentional and Reaction Abilities for Fall Risk Evaluation
An observational study of Aging and Fall Risk Factors, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Fall Risk Factors, Sleep
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2025to 30 Jul 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Motor and Cognitive Abilities in Relation to Fall Risk: Use of Virtual Reality for the Assessment of Attentional and Reaction Capacities
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days ± 3 days after the familiarization day
Secondary outcomes (17)
Virtual reality (VR-Brain Tracker)
Evaluation to assess visual attention through the Multiple Object Tracking paradigm.
Measured: 10 days ± 3 days after the familiarization day
Strength asessment
Handgrip Test (Kg) Flexors and Extensors of thigh muscles (Kg)
Measured: 10 days ± 3 days after the familiarization day
Balance test
balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)
Measured: 10 days ± 3 days after the familiarization day
Sleep assessment
Objective assessment of sleep quantity and quality using the MotionWatch 8® (CamTec, USA), and sleep diary.
Measured: sleep monitoring duration: 10 days ± 3 days after the familiarization day
Sleep Hygene Index
Questionnaire to assess the sleep hygene
Measured: 10 days ± 3 days after the familiarization day
Body Impedence Assessment
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.
Measured: T1
Virtual reality (CNS Sprint)
To assess the response time (ms)
Measured: 10 days ± 3 days after the familiarization day
Virtual reality (Visual efficiency)
To assess the visual field
Measured: 10 days ± 3 days after the familiarization day
The Pittsburgh Sleep Quality Index
Questionnaire to assess sleep quality
Measured: 10 days ± 3 days after the familiarization day
Morningness-Eveningness Questionnaire
Questionnaire to assess the chronotype
Measured: 10 days ± 3 days after the familiarization day
Karolinska Sleepiness Scale
Scale to assess the sleepiness
Measured: 10 days ± 3 days after the familiarization day
Tiredness Severity Scale
Scale to assess the tiredness
Measured: 10 days ± 3 days after the familiarization day
SARC-F
A QUESTIONNAIRE FOR SCREENING THE RISK OF SARCOPENIA
Measured: 10 days ± 3 days after the familiarization day
International Physical Activity Questionnaire
Questionnaire to assess the physical activity
Measured: 10 days ± 3 days after the familiarization day
BORG-CR10 scale
EFFORT PERCEPTION SCALE
Measured: 10 days ± 3 days after the familiarization day
Mini Nutritional Assessment
QUESTIONNAIRE TO ASSESS THE RISK OF MALNUTRITION
Measured: 10 days ± 3 days after the familiarization day
Nutritional diary
Keeping a food diary helps collect accurate data on participants' eating habits for scientific analysis.
Measured: 10 days ± 3 days after the familiarization day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940245
- Sponsor's protocol ID
- VR&RISKofFALL
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor and Cognitive Abilities in Relation to Fall Risk: Use of Virtual Reality for the Assessment of Attentional and Reaction Capacities
- ClinicalTrials.gov ID
- NCT06940245
- Acronym / sponsor ID
- VR&RISKofFALL
- Conditions
- Aging, Fall Risk Factors, Sleep
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
17 secondary outcomes
Virtual reality (VR-Brain Tracker)
Time frame: 10 days ± 3 days after the familiarization day
Strength asessment
Time frame: 10 days ± 3 days after the familiarization day
Balance test
Time frame: 10 days ± 3 days after the familiarization day
Sleep assessment
Time frame: sleep monitoring duration: 10 days ± 3 days after the familiarization day
Sleep Hygene Index
Time frame: 10 days ± 3 days after the familiarization day
Body Impedence Assessment
Time frame: T1
Virtual reality (CNS Sprint)
Time frame: 10 days ± 3 days after the familiarization day
Virtual reality (Visual efficiency)
Time frame: 10 days ± 3 days after the familiarization day
The Pittsburgh Sleep Quality Index
Time frame: 10 days ± 3 days after the familiarization day
Morningness-Eveningness Questionnaire
Time frame: 10 days ± 3 days after the familiarization day
Karolinska Sleepiness Scale
Time frame: 10 days ± 3 days after the familiarization day
Tiredness Severity Scale
Time frame: 10 days ± 3 days after the familiarization day
SARC-F
Time frame: 10 days ± 3 days after the familiarization day
International Physical Activity Questionnaire
Time frame: 10 days ± 3 days after the familiarization day
BORG-CR10 scale
Time frame: 10 days ± 3 days after the familiarization day
Mini Nutritional Assessment
Time frame: 10 days ± 3 days after the familiarization day
Nutritional diary
Time frame: 10 days ± 3 days after the familiarization day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Fall Risk Factors, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 - second chair stand test (time frame: 10 days ± 3 days after the familiarization day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.