NCT06522802

Brief Summary

A mask is a protective equipment that covers the mouth and nose and is routinely used in workplaces, public transport and other communal settings preventing harmful particles, dust, droplets, bacteria, viruses, fog, gas, smoke and steam from entering the respiratory system. However, wearing a mask may impair the visual field, potentially affecting balance and reaction time. The investigators' aim is to determine whether the use of masks affects people's balance and reactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

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

December 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 12, 2024

Last Update Submit

July 22, 2024

Conditions

Reaction TimeBalance

Outcome Measures

Primary Outcomes (1)

  • Functional reach test

    Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in in simple task. As we know that this test measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.

    baseline-5 hours later

Secondary Outcomes (2)

  • COP displacement

    baseline-5 hours later

  • BlazePod evaluation

    baseline-5 hours later

Study Arms (1)

Evaluation Arm

EXPERIMENTAL

Only one group evaluated

Diagnostic Test: balance tests, reaction time evaluation

Interventions

balance tests, reaction time evaluationDIAGNOSTIC_TEST

Only 3 tests were applied to participants

Evaluation Arm

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be healthy

You may not qualify if:

  • present or previous balance disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, MSc, PhD

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 26, 2024

Study Start

December 8, 2020

Primary Completion

May 30, 2021

Study Completion

January 10, 2022

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)