The Reliability And Validity Of A Smartphone App | NCT05819242

Studies
The Reliability And Validity Of A Smartphone App

NCT05819242

Sponsor

Kirsehir Ahi Evran Universitesi

Status

Completed

Last Update Posted

Oct 6, 2023Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis
Carpal Tunnel Syndrome

Interventions

Angulus

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

Oct 2023

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 7, 2023Actual

Primary Completion Date

Oct 5, 2023Actual

Completion Date

Oct 5, 2023Actual

First Submitted Date

Apr 6, 2023

First Submission Date that Met QC Criteria

Apr 6, 2023

First Posted Date

Apr 19, 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

Oct 5, 2023

Last Update Posted Date

Oct 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ömer Faruk ÖZÇELEP, Researcher, Kirsehir Ahi Evran UniversitesiPrincipal Investigator

Lead Sponsor

Kirsehir Ahi Evran UniversitesiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 goal of this observational study is to validate a smartphone app called Angulus. The main question it aims to answer is:

• Is an Angulus App valid and reliable system for masuring hand and wrist range of motion?

Participants will be evaluated by goniometers which is a gold standart for range of motion assessment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Adults			Diagnostic Test: Angulus
Rheumatoid Arthritis			Diagnostic Test: Angulus
Carpal Tunnel Syndrome			Diagnostic Test: Angulus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Angulus	Diagnostic Test	Smartphone app	Carpal Tunnel Syndrome Healthy Adults Rheumatoid Arthritis

Measure	Description	Time Frame
Range of Motions		15 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a history of previous traumatic hand or wrist injury in the upper extremity,
pain in the hand and wrist during evaluation
orthopedic, neurologic, or rheumatologic disease

Exclusion Criteria:

not to understand the command that the therapist give

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahi Evran University		Kırşehir			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided