NCT05890937

Brief Summary

Objectives: This study aimed to examine the impact of mental stress on balance systems in healthy adults. Study population \& Sample size: Participants were delimited to 178 students that enter oral and practical exams at different levels in Faculty of Physical Therapy, KafrEl-Sheikh University. Balance was measured using mini-SITCIB test before and after the exam. another 40 subject that have no exam were recruited to work as control group Study Design : it is a controlled trial. Methods : After obtaining the consent form, and demographics. The mobile application was opened, and a new experiment was created. Abdominal support was modified so it contains a pocket in its centre so the mobile can fit onto it. Participants were asked to conduct a mini-SITCIB test before and after the exam in experimental group and before and after 30 min in control group. The data was extracted and stored anonymously on the hard drive as CSV files.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

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

First Submitted

Initial submission to the registry

May 15, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

April 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

May 15, 2023

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Jerk in X,Y,Z

    Captured by accelerometer readings

    2 weeks

  • Swaying in X,Y,Z

    Captured by Gyroscope readings

    2 weeks

Study Arms (2)

Mental stress group

EXPERIMENTAL

they were expected to take their exams just after the assessment and before measuring for the second time

Diagnostic Test: Oral and practical exam

Control group

NO INTERVENTION

they were expected to take nothing for 30 min just after the assessment and before measuring for the second time

Interventions

Oral and practical exam that performed at the end of the semester

Mental stress group

Eligibility Criteria

Age17 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BMI between 20 and 30
  • free of any diseases

You may not qualify if:

  • any trauma within last 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh university

Kafrelsheikh, Egypt

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 6, 2023

Study Start

December 20, 2023

Primary Completion

February 20, 2025

Study Completion

February 20, 2025

Last Updated

April 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations