Validity and Reliability of the Smart Speed Device | NCT06072144

Studies
Validity and Reliability of the Smart Speed Device

NCT06072144

Sponsor

Afyonkarahisar Health Sciences University

Status

Completed

Last Update Posted

Jul 31, 2024Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Healthy Volunteers

Interventions

Validity and reliability study

Countries

Turkey (Türkiye)

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

Jul 2024

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

May 6, 2024Actual

Primary Completion Date

Jun 7, 2024Actual

Completion Date

Jul 24, 2024Actual

First Submitted Date

Sep 22, 2023

First Submission Date that Met QC Criteria

Oct 2, 2023

First Posted Date

Oct 10, 2023Actual

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

Jul 30, 2024

Last Update Posted Date

Jul 31, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emel Taşvuran Horata, Associate Professor, Afyonkarahisar Health Sciences UniversityPrincipal Investigator

Lead Sponsor

Afyonkarahisar Health Sciences UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The Smart Speed device developed at Zafer Teknopark in Turkey was developed to objectively assess reaction time. The aim of this study was to evaluate the validity and reliability of the Smart Speed device in comparison with BlazePod and Nelson Reaction Test.

Detailed Description

The capacity to perceive, analyze, and react to a signal is referred to as reaction time. Reaction time is influenced by many factors such as visual and auditory factors. It is also influenced by individual factors such as age, gender, body mass index, attention and fatigue. Having reaction time within normal limits is very important for maintaining activities of daily living. BlazePod is a valid and reliable device for the assessment of reaction time. The Nelson Reaction test is also a valid and reliable test frequently used in the clinic for the assessment of reaction time due to its simple and rapid application. The Smart Speed device developed at Zafer Teknopark in Turkey was developed to objectively assess reaction time. The aim of this study was to evaluate the validity and reliability of the Smart Speed device in comparison with BlazePod and Nelson Reaction Test.

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

37Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Validity and reliability study	Other	Test-retest method will be used to assess reliability. For this purpose, participants will be re-evaluated one week later with the Smart Speed device. For validity assessment, concurrent validity and agreement between measurements will be evaluated. Concurrent validity will be assessed by correlation analysis and agreement between measurements will be assessed by Bland Altman.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of reaction time	To determine the validity and reliability of the Smart Speed device in assessing reaction time	15 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Without having systemic disease
To be able to speak Turkish language

Exclusion Criteria:

Having a problem that affects physical performance

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

24 Years

Standard Ages

Adult

Study Population

Participants will be healthy young people between the ages of 18-24. All participants will be recruited from Afyonkarahisar Health Sciences University Physiotherapy and Rehabilitation Department.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emel TAŞVURAN HORATA, PhD	Afyonkarahisar Health Sciences University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fatma EKEN		Afyonkarahisar	Center	03030	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided