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

April 15, 2025 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
10 days ± 3 days after the familiarization day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
10 days ± 3 days after the familiarization day
Strength asessment
Time Frame: 10 days ± 3 days after the familiarization day
Handgrip Test (Kg) Flexors and Extensors of thigh muscles (Kg)
10 days ± 3 days after the familiarization day
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)
10 days ± 3 days after the familiarization day
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.
sleep monitoring duration: 10 days ± 3 days after the familiarization day
Sleep Hygene Index
Time Frame: 10 days ± 3 days after the familiarization day
Questionnaire to assess the sleep hygene
10 days ± 3 days after the familiarization day
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.
T1
Virtual reality (CNS Sprint)
Time Frame: 10 days ± 3 days after the familiarization day
To assess the response time (ms)
10 days ± 3 days after the familiarization day
Virtual reality (Visual efficiency)
Time Frame: 10 days ± 3 days after the familiarization day
To assess the visual field
10 days ± 3 days after the familiarization day
The Pittsburgh Sleep Quality Index
Time Frame: 10 days ± 3 days after the familiarization day
Questionnaire to assess sleep quality
10 days ± 3 days after the familiarization day
Morningness-Eveningness Questionnaire
Time Frame: 10 days ± 3 days after the familiarization day
Questionnaire to assess the chronotype
10 days ± 3 days after the familiarization day
Karolinska Sleepiness Scale
Time Frame: 10 days ± 3 days after the familiarization day
Scale to assess the sleepiness
10 days ± 3 days after the familiarization day
Tiredness Severity Scale
Time Frame: 10 days ± 3 days after the familiarization day
Scale to assess the tiredness
10 days ± 3 days after the familiarization day
SARC-F
Time Frame: 10 days ± 3 days after the familiarization day
A QUESTIONNAIRE FOR SCREENING THE RISK OF SARCOPENIA
10 days ± 3 days after the familiarization day
International Physical Activity Questionnaire
Time Frame: 10 days ± 3 days after the familiarization day
Questionnaire to assess the physical activity
10 days ± 3 days after the familiarization day
BORG-CR10 scale
Time Frame: 10 days ± 3 days after the familiarization day
EFFORT PERCEPTION SCALE
10 days ± 3 days after the familiarization day
Mini Nutritional Assessment
Time Frame: 10 days ± 3 days after the familiarization day
QUESTIONNAIRE TO ASSESS THE RISK OF MALNUTRITION
10 days ± 3 days after the familiarization day
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.
10 days ± 3 days after the familiarization day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VR&RISKofFALL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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