Smartphone & Headphone Effects on Baropodometric Parameters

Postural; Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400576
• Other study ID #: SPP
• Status: Recruiting
• Start date: April 25, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Hacettepe University
• Contact: Hatice Cetin
• Phone: 03123052565
• Email: haticebitirim[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

During our daily lives, we 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 statet 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Dual Task
• Postural; Defect
• Smartphone Addiction

Intervention

Other:
• Headphone and Smartphone Intervention
Asessment of participants' static balance and pressure distrubiton, posturographic balance and dynamic balance whilst using headphones and messaging.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara
Turkey	Hatice Cetin	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Forward Head Posture	It will be assesed with a digital inclinometer, the measurement unit will be in degrees.	At Baseline
Secondary	New York Posture Assesment	This form will asses participants' postural alignment.	At Baseline
Secondary	International Physical Activity Questionnaire	This form will asses participants' physical fitness and well-being.	At Baseline
Secondary	The Cognitive Flexibility Inventory	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