Validity and Reliability of the PhysioMaster Application... | NCT06830928

Studies
Validity and Reliability of the PhysioMaster Application in Measuring Wrist Range of Motion (ROM) Among Healthy Adults

NCT06830928

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Feb 17, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

PhysioMaster Application in Measuring Wrist Range of Motion (ROM)

Interventions

Not provided

Countries

Not provided

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2025Estimated

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Feb 12, 2025

First Submission Date that Met QC Criteria

Feb 12, 2025

First Posted Date

Feb 17, 2025Actual

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

Feb 12, 2025

Last Update Posted Date

Feb 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zeinab Abd el fattah Ali, Assistant Professor of physical therapy for surgery, Faculty of physical therapy, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Universal Goniometer (UG) is a well-established tool for measuring joint range of motion (ROM). However, it presents limitations, including dependence on examiner skill, which can introduce error. With advances in digital technology, smartphone-based applications, such as PhysioMaster, now offer an alternative approach that potentially reduces human error and increases measurement precision

Detailed Description

Measuring Wrist ROM Using the electronic Goniometer

The following protocol will be implemented to measure wrist ROM for the enrolled female participants:

Wrist Flexion-Extension Testing Position: Elbow flexed at 90 degrees, with the wrist positioned over the edge of a table and the forearm in full pronation.

Goniometer Axis: Lateral placement over the triquetrum. Stationary Arm: Aligned with the lateral midline of the ulna, directed toward the olecranon process.

Moving Arm: Aligned with the lateral midline of the 5th metacarpal. Wrist Radial-Ulnar Deviation Testing Position: Elbow flexed at 90 degrees, wrist positioned over the edge of a table with the forearm in full pronation.

Goniometer Axis: Positioned over the dorsal capitate. Stationary Arm: Aligned with the dorsal midline of the forearm. Moving Arm: Positioned parallel to the longitudinal axis of the third metacarpal (Surangsrirat et al., 2022).

Measurement using the smartphone inclinometer-based application For measurements using the smartphone inclinometer application, the smartphone was placed on the participant's wrist, with elbows and upper arms positioned against a wall and flat along their torsos for each movement. This standardized setup ensured consistent smartphone positioning across all ROM measurements .

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wrist rane of motion	This study employed the digital Goniometer to measure wrist Range of Motion (ROM) in terms of extension, flexion, radial deviation, and ulnar deviation. Additionally, a smartphone inclinometer-based application, PhysioMaster, was used as a comparative tool, compatible with both Android and iOS systems	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- A sample of 30 female participants, aged 19 to 50 years, was selected for this study. Inclusion criteria required participants to be within this age range

Exclusion Criteria:

any wrist pain, rheumatoid conditions, trauma, prior hand surgeries, deformities in either hand, or pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

A sample of 30 female participants, aged 19 to 50 years, was selected for this study. Inclusion criteria required participants to be within this age range and free from any wrist pain, rheumatoid conditions, trauma, prior hand surgeries, deformities in either hand, or pregnancy

Sampling Method

Probability Sample