BalanceDEPIENCT06682754
Detection of Balance in the Elderly Under the Influence of Stress
A study testing Stress in people with Balance, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 27 Nov 2024to Jul 2026
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young adults (ages 18-39).
- Older adults (≥65).
- Voluntarily participate in the study.
- Not meeting the exclusion criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Alcalá
Alcalá de Henares
Susana N Núñez, PhD. Associate Professor, 0034918852524, susana.nunez@uah.es
About this study
Official title: Use of Balance Detection Devices for Elderly People Under the Influence of Stress (DEPIE)
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.
Read more
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.
- Conditions
- Balance
- Being tested
- Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StressOther
All participants will perform a baseline test in which they will first be asked to visualize low-arousal IAPS images for three minutes while seated in a chair, and then get up, walk to a table with two bottles, transfer liquid from one bottle to the other, return to the starting chair and sit down again. Subsequently, they will perform an experimental test, where they will repeat the same movements as in the baseline test after visualizing high-arousal IAPS images for three minutes. In addition, IAPS images will continue to be projected in the background while participants perform the described motor tasks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All participants will perform a baseline and an experimental test. There will be a group of young people and a group of older people, but all participants will perform the same intervention Receives: Other: Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressures on the floor
They will be measured by a sensorised blanket that will give information on weight distribution and movement behaviour
Measured: 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
Triaxial accelerometry: acceleration and deceleration in object handling
The maximum acceleration value during the handling activity of two bottles shall be measured with sensors installed on the bottles.
Measured: 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
RMS value of the EMG signal
The root mean square (RMS) value of the EMG signal reflects the level of muscle activation during activity.
Measured: 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
EMG: Synchronisation of activation between muscle groups
It will assess in milliseconds the ability of the muscles to work in a synchronised manner.
Measured: 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
EMG: Activation ratio between upper and lower body muscles
RMS ratio between different muscles
Measured: 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
EMG: Median Frequency (MDF)
In the frequency domain, this median frequency of the EMG signal will be calculated.
Measured: 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
Balance
It will be assessed by Timed Up and Go Test (TUG) and Functional Reach Test (FRT)
Measured: Before the baseline test and after the experimental test
Secondary outcomes (3)
Heart Rate Variability
It will be explored for measures of autonomic nervous system activation
Measured: 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 explored for measures of autonomic nervous system activation
Measured: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test
Analog Visual Scale
It will assess the feeling of unease after performing the baseline test and the experimental test respectively. The scale consists of a line from 0 (= totally relaxed) to 10 (=the most uneasy or restless feeling you have ever felt), which participants have to mark according to their feelings at that moment. Higher scores will correspond to a greater sense of unease.
Measured: Immediately after the baseline test and the experimental test respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start27 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Castilla-La Mancha Health Service
- Responsible party
- Principal investigator, Susana Nunez Nagy, University of Alcala
- Investigators
- Susana N Núñez, PhD. Associate Professor, Principal investigator, University of AlcaláBernardo A Alarcos, PhD. Full Professor, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682754
- Sponsor's protocol ID
- CEIP/2023/5/110
- Acronym
- DEPIE
- Status last verified
- Aug 2025
- First submitted
- 31 Oct 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Membership of GITES; Alarcos B, Diaz-Pulido B, Fernandez O, Fernandez-Guinea S, Garcia Herraiz A, Lendinez-Chica MDM, Martinez Muela J, Nunez-Nagy S, Perez-Martin Y, Rodriguez-Costa I, Rubio Gonzalez GM, Trapero-Asenjo S, Velasco JR. Detection of balance in the elderly under the influence of stress (DEPIE): A cross-sectional study protocol. PLoS One. 2026 Jan 27;21(1):e0341744. doi: 10.1371/journal.pone.0341744. eCollection 2026.
PubMed 41592138
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Balance Detection Devices for Elderly People Under the Influence of Stress (DEPIE)
- ClinicalTrials.gov ID
- NCT06682754
- Acronym / sponsor ID
- DEPIE / CEIP/2023/5/110
- Conditions
- Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- European Union, Castilla-La Mancha Health Service
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Nov 2024 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: StressAll participants will perform a baseline and an experimental test. There will be a group of young people and a group of older people, but all participants will perform the same intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Young adults (ages 18-39).
- Older adults (≥65).
- Voluntarily participate in the study.
- Not meeting the exclusion criteria
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StressAll participants will perform a baseline test in which they will first be asked to visualize low-arousal IAPS images for three minutes while seated in a chair, and then get up, walk to a table with two bottles, transfer liquid from one bottle to the other, return to the starting chair and sit down again. Subsequently, they will perform an experimental test, where they will repeat the same movements as in the baseline test after visualizing high-arousal IAPS images for three minutes. In addition, IAPS images will continue to be projected in the background while participants perform the described motor tasks. | Other | Experimental |
Primary outcome
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)
3 secondary outcomes
Heart Rate Variability
Time frame: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test
Respiratory Rate
Time frame: It will be assessed during the visualization of IAPS images both during the baseline test and during the experimental test
Analog Visual Scale
Time frame: Immediately after the baseline test and the experimental test respectively
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 7 Aug 2025.
- Derived from this study: PubMed 41592138Membership of GITES; Alarcos B, Diaz-Pulido B, Fernandez O, Fernandez-Guinea S, Garcia Herraiz A, Lendinez-Chica MDM, Martinez Muela J, Nunez-Nagy S, Perez-Martin Y, Rodriguez-Costa I, Rubio Gonzalez GM, Trapero-Asenjo S, Velasco JR. Detection of balance in the elderly under the influence of stress (DEPIE): A cross-sectional study protocol. PLoS One. 2026 Jan 27;21(1):e0341744. doi: 10.1371/journal.pone.0341744. eCollection 2026.
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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.
Susana N Núñez, PhD. Associate Professor principal investigator
University of Alcalá
Bernardo A Alarcos, PhD. Full Professor principal investigator
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress in people with Balance, run by University of Alcala at 1 site in Spain.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Susana N Núñez, PhD. Associate Professor (0034918852524, susana.nunez@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682754, which also lists 1 linked publication.
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 7 Aug 2025.