NCT06400576

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

April 29, 2024

Last Update Submit

October 23, 2024

Conditions

Keywords

Postural oscillationHeadphone useMessagingBalanceGaitFoot Pressure DistrubitionSmartphone addictionDaily activites

Outcome Measures

Primary Outcomes (12)

  • Baropodometer assessments- Static pressure distribution

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (4)

  • Forward Head Posture

    At Baseline

  • New York Posture Assesment

    At Baseline

  • International Physical Activity Questionnaire

    At Baseline

  • The Cognitive Flexibility Inventory

    At Baseline

Study Arms (1)

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

Interventions

Asessment of participants' static balance and pressure distrubiton, posturographic balance and dynamic balance whilst using headphones and messaging.

Also known as: FreeMed Baropodometric Device
Headphone and Smartphone Usage Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy young people who are volunteering to participate the study.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hatice Cetin

Ankara, 06800, Turkey (Türkiye)

Location

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Hatice Cetin

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist, Prof

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 6, 2024

Study Start

April 25, 2024

Primary Completion

July 28, 2024

Study Completion

October 23, 2024

Last Updated

October 24, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations