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Clinical Trials/NCT06682754
NCT06682754
Recruiting
N/A

Use of Balance Detection Devices for Elderly People Under the Influence of Stress (DEPIE)

University of Alcala1 site in 1 country60 target enrollmentNovember 27, 2024
ConditionsBalance

Overview

Phase
N/A
Intervention
Not specified
Conditions
Balance
Sponsor
University of Alcala
Enrollment
60
Locations
1
Primary Endpoint
Pressures on the floor
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

The aging process involves physiological changes in organs and tissues that can evolve towards fragility and increased risk of falls. Falls, which can be one of the adverse results of frailty in older people, are the second leading cause of death worldwide. When an elderly person falls, it entails not only hospitalization, immobilization, and the consequent deterioration, but also usually causes fear of falling again, which can also lead to the onset of disability. The inherent aging process can be linked to the deterioration of postural control and balance, posing serious health problems. In falls in the elderly, both sensorimotor and cognitive functions are affected, the functioning of which is degraded to a greater extent by anxiety and stress. Nowadays, more extensive, and more precise research is needed in the study of the interactions between cognition, stress, and postural control in the context of postural instability and falls in older adults.

The purpose of the DEPIE Project is to detect whether neuromuscular changes that occur when exposed to stressful situations can affect the postural and motor control of the elderly.

To this end, all participants will undergo the same intervention. Firstly, they will all take a baseline cognitive and physical assessment. Afterwards, they will take the experimental session, which will consist of a baseline test and an experimental test. During the baseline test, participants will visualize International Affective Picture System (IAPS) images of low arousal and during the experimental test of high arousal. Finally, physical assessment tests will be repeated.

Young and older adults will be tested. Additionally, sub-analyses will be conducted within the elderly group differentiating the degree of cognitive impairment and functional dependence.

The primary outcome measures will be surface electromyography, pressures on the floor, activity on manipulation, and balance.

The secondary outcome measures will be heart rate variability, respiratory rate and the visual analogue scale on unease after visualisation of the images.

Registry
clinicaltrials.gov
Start Date
November 27, 2024
End Date
July 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Alcala
Responsible Party
Principal Investigator
Principal Investigator

Susana Nunez Nagy

PhD. Associate Professor.

University of Alcala

Eligibility Criteria

Inclusion Criteria

  • Young adults (ages 18-39).
  • Older adults (≥65).
  • Voluntarily participate in the study.
  • Not meeting the exclusion criteria

Exclusion Criteria

  • Any disease, injury, or previous trauma that contraindicates muscular exertion, balance exercises, and/or walking.
  • Any physical or mental illness that contraindicates exposure to stimuli generating emotional stress, such as severe depression or severe psychosis
  • Difficulties in understanding study information and providing informed consent

Outcomes

Primary Outcomes

Pressures on the floor

Time Frame: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test

They will be measured by a sensorised blanket that will give information on weight distribution and movement behaviour

Triaxial accelerometry: acceleration and deceleration in object handling

Time Frame: It will be assessed while performing the bottle manipulation movement (during which liquid has to be transferred from one bottle to another), both during the baseline test and during the experimental test

The maximum acceleration value during the handling activity of two bottles shall be measured with sensors installed on the bottles.

RMS value of the EMG signal

Time Frame: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test

The root mean square (RMS) value of the EMG signal reflects the level of muscle activation during activity.

EMG: Synchronisation of activation between muscle groups

Time Frame: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test

It will assess in milliseconds the ability of the muscles to work in a synchronised manner.

EMG: Activation ratio between upper and lower body muscles

Time Frame: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test

RMS ratio between different muscles

EMG: Median Frequency (MDF)

Time Frame: It will be assessed while performing the movements of getting up from the chair, walking, manipulating the bottles, returning to the chair and sitting down, both during the baseline test and during the experimental test

In the frequency domain, this median frequency of the EMG signal will be calculated.

Balance

Time Frame: Before the baseline test and after the experimental test

It will be assessed by Timed Up and Go Test (TUG) and Functional Reach Test (FRT)

Secondary Outcomes

  • Heart Rate Variability(It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test)
  • Respiratory Rate(It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test)
  • Analog Visual Scale(Immediately after the baseline test and the experimental test respectively)

Study Sites (1)

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