Smartphone and Posture Control In Healthy Adolescents | NCT04775342

Studies
Smartphone and Posture Control In Healthy Adolescents

NCT04775342

Sponsor

Cairo University

Status

Completed

Last Update Posted

May 24, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Balance

Interventions

smartphone

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2021Actual

Primary Completion Date

Jul 2, 2021Actual

Completion Date

Nov 27, 2021Actual

First Submitted Date

Feb 25, 2021

First Submission Date that Met QC Criteria

Feb 26, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2022

Last Update Posted Date

May 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study to determine if smartphone use affect posture control in adolescents.

Detailed Description

It is within subject repeated measure study to determine if touch screen use affect posture control in healthy adolescents.

200 normal adolescents between 14 and 18 years old will be included.

1st they will be assessed for posture control to determine normal values for their ages, then each child will be given smartphone to play a game while the sound is muted for 15 min then their balance will be re-assessed, finally they will use the phone for another 15 min but the children will use headphone piece this time then re-assess balance.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 group		1 group will be assessed then will be given smartphone to use and assessed	Device: smartphone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
smartphone	Device	modern technology	1 group	touch screen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
center of pressure	a metric for measuring changes in posture control	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children age from 14 to 18 years old.
Both genders will be included.
Normal Body mass index (BMI) for age.
Children using smartphone for at least 1 year.

Exclusion Criteria:

Obese children.
children with vestibular or visual problems.
Children with neurological disorders.
Children with congenital deformities or musculoskeletal disorders.
Children with cognitive impairment.
Injuries or inflammatory conditions involving the extremities.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Normal Adolescents

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amira M Eltohamy	professor at Cairo university	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Esraa Abd Elaziz Anter Abd Elaziz		Cairo			Egypt