Smartphone & Headphone Effects on Baropodometric Parameters

October 23, 2024 updated by: HATİCE ÇETİN, Hacettepe University

Effects of Smartphone and Headphone Usage on Baropodometric Parameters in Healthy Individuals

The goal of this observational study is to observe baropodometric parameters such as postural sway and foot pressure distrubiton in healthy young participants between the ages of 18-35. The main questions it aims to answer are:

  • How does headphone usage affect baropodometric parameters in healthy young individuals?
  • How does texting affect baropodometric parameters in healthy young individuals?
  • How does headphone usage while texting affect baropodometric parameters in healthy young individuals?

Participants will:

  • Only be evaluated once.
  • Stand on the Baropodometric device platform while standing, texting, listening to music, texting while listening to music for the static and posturographic balance evaluation.
  • Walk on the baropdometric device platform while standing, texting, listening to music, texting while listening to music for dynamic evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During our daily lives, the individuals perform many functions simultaneously. Two devices that modern technology has brought us are headphones and mobile phones, both of which are commonly used. Studies have shown that posture oscillation changes during walking while using a phone, but same studies also stated that more comprehensive studies are needed. There is no study in the literature that examines postural oscillation and foot pressure distribution while listening to music with headphones and messaging. The aim of this observational study is to evaluate the postural oscillation and foot pressure distribution during headphone use and messaging in healthy participants aged 18-35. The sample size of 35 participants was determined based on a similar study example using G-Power analysis. Participants will be assesed at Hacettepe University, Faculty of Physical Therapy and Rehabilitation. Participants will be selected based on eligibility criteria, and there will be only one group in the study; therefore, randomization will not be performed. Participants enrolled in the study will be evaluated using the FreeMED force platform (Sensor Medica, Italy). The platform itself is 40x40 cm in size and comes with two plates, each one meter long. When all components are assembled, a continuous surface of 2.4 meters is obtained. Participants will participate in static, posturographic, and dynamic evaluations. In each evaluation, participants will first stand still, then put on headphones and listen to music at 80 decibels with a tempo of 130 bpm, then type a message, and finally type a message while listening to music. Static evaluation will provide information about foot pressure distribution; posturographic evaluation will include Romberg tests with eyes open, eyes closed, standing on one foot, and standing on two feet; and dynamic evaluation will assess participants' walking phases and speed. The statistical analysis of the study will be performed using SPSS 23.0 software.

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 (Actual)

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.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University
      • Ankara, Turkey, 06800
        • Hatice Cetin

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

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy young people who are volunteering to participate the study.

Description

Inclusion Criteria:

  • Agreeing to participate in the study voluntarily,
  • Being between the ages of 18-35

Exclusion Criteria:

  • Not agreeing to participate in the study voluntarily.
  • Having a congenital spinal cord anomaly
  • Existing neurological, orthopedic, inflammatory, cardiovascular, rheumatological, vestibular problems
  • Having a surgical history of the spinal region

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Headphone and Smartphone Usage Group
The group where participants listen to music while messaging and also where these activities are evaluated separately. The only group in the study.
Other: Headphone and Smartphone Intervention
Asessment of participants' static balance and pressure distrubiton, posturographic balance and dynamic balance whilst using headphones and messaging.
Other Names:
  • FreeMed Baropodometric Device

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
Baropodometer assessments- Static pressure distribution
Time Frame: through study intervention, an average of 15 minutes
Pressure distribution will be assessed with FreeMed baropodometric platform and the recording measurement unit will be percentages.
through study intervention, an average of 15 minutes
Baropodometer assessments- Posturographic center of gravity
Time Frame: through study intervention, an average of 15 minutes
Center of gravity will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
through study intervention, an average of 15 minutes
Baropodometer assessments- Posturographic oscillations
Time Frame: through study intervention, an average of 15 minutes
Oscillations will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
through study intervention, an average of 15 minutes
Baropodometer assesments - Posturographic Sway Length
Time Frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
through study intervention, an average of 15 minutes
Baropodometer assesments - Posturographic Displacement Towards X and Y axis
Time Frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
through study intervention, an average of 15 minutes
Baropodometer assessments- Posturographic average sway velocity
Time Frame: through study intervention, an average of 15 minutes
Sway velocity will be assessed with FreeMed baropodometric platform and the recording measurement unit will be degrees.
through study intervention, an average of 15 minutes
Baropodometer assessments- Dynamic average surface
Time Frame: through study intervention, an average of 15 minutes
Average surface will be assessed with FreeMed baropodometric platform and the recording measurement unit will be cm.
through study intervention, an average of 15 minutes
Baropodometer assessments- Dynamic average speed
Time Frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters/second.
through study intervention, an average of 15 minutes
Baropodometer assesments - Dynamic Gait Phase Durations
Time Frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be percentages
through study intervention, an average of 15 minutes
Feet Loading Pattern - Dynamic Longitudinal Arc
Time Frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
through study intervention, an average of 15 minutes
Feet Loading Pattern - Forefoot Reatfoot Load
Time Frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
through study intervention, an average of 15 minutes
Feet Loading Pattern - Medial Lateral Load
Time Frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
through study intervention, an average of 15 minutes

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
The Cognitive Flexibility Inventory
Time Frame: At Baseline
The Cognitive Flexibility Inventory is a 20-item self-report measure to monitor how often individuals engaged in cognitive behavioural thought challenging interventions. The total score ranges between 20 and 140, where higher scores indicate more cognitive flexibility.
At Baseline
Forward Head Posture
Time Frame: At Baseline
It will be assessed with a digital inclinometer, the measurement unit will be in degrees.
At Baseline
New York Posture Assesment
Time Frame: At Baseline
This form will assess participants' postural alignment. Total scores range from 13 to 65, with results categorized as: 'excellent' (above 45), 'good' (40-44), 'fair' (30-39), 'poor' (20-29), and 'very poor'.
At Baseline
International Physical Activity Questionnaire
Time Frame: At Baseline
This form will assess participants' physical fitness and well-being. Based on MET minutes per week, the results are categorized into three activity levels: inactive, minimally active and very active.
At Baseline

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.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hatice Cetin, Hacettepe University

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 (Actual)

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 25, 2024

Primary Completion (Actual)

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 28, 2024

Study Completion (Actual)

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.
October 23, 2024

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 29, 2024

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.
May 2, 2024

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.
May 6, 2024

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.
October 24, 2024

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.
October 23, 2024

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.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • SPP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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