Psychometric Properties of a Mobile Application

Spinal Cord Injuries Clinical Trial

— IMITO  

Official title:

Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402398
• Other study ID #: RECHMPL19_0280
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Current methods to assess superficial size and area of pressure ulcers are either time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or necessitating to touch the patient's skin (using commun rulers).

A free smartphone application (for IOS or Android) has recently been developed to measures skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A photograph is taken with the smartphone, the limits of the lesion is then drawn with the health carers' finger on the phone's screen. The application computes the length, width and surface of the ulcer.

This technique has not yet been validated, although it has been used to measure various types of skin lesions.

The objective of this study is to validate this measurement technique on a sample of pressure ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by comparison to the currently most frequently used techniques (Transparency Tracings and ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.

imitoMeasure is a new smartphone application to measure wounds size. The present study assesses validity of the measure against common measures (ruler-based and transparency tracings), and the inter- and intra-rater reliability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 20, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• complete or incomplete spinal cord injury, all delays or aetiologies

• presence of one or more pressure ulcers stade II to IV

• adults

Exclusion criteria:

• refusal to participate

• local infection

Related Conditions & MeSH terms

• Spinal Cord Injuries

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure	Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure	immediately upon first assessment of patients
Secondary	Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure	Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure	immediately upon first assessment of patients
Secondary	inter-rater and intra-rater validity of imitoMeasure	inter-rater and intra-rater validity of imitoMeasure	immediately upon first assessment of patients
Secondary	Correlation of imitoMeasure of length and width of ulcers to ruler-based measures	Correlation of imitoMeasure of length and width of ulcers to ruler-based measures	immediately upon first assessment of patients