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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06400576
Other study ID # SPP
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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