Spinal Cord InjuriesIMITONCT04402398
Psychometric Properties of a Mobile Application
An observational study of Spinal Cord Injuries, run by University Hospital, Montpellier at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 20 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients, providing consent for study, with complete or incomplete spinal cord injury, with pressure ulcers requiring hospital follow-up (lesion stade II to IV), followed at Centre Mutualiste Propara, rehabilitation centre, Montpellier, France
Who may be able to join
- complete or incomplete spinal cord injury, all delays or aetiologies
- presence of one or more pressure ulcers stade II to IV
- adults
Who cannot join
- refusal to participate
- local infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)
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.
Read more
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.
- Conditions
- Spinal Cord Injuries
- Keywords
- Pressure ulcer, validity of measures
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure
Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure
Measured: immediately upon first assessment of patients
Secondary outcomes (3)
Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure
Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure
Measured: immediately upon first assessment of patients
inter-rater and intra-rater validity of imitoMeasure
inter-rater and intra-rater validity of imitoMeasure
Measured: immediately upon first assessment of patients
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
Measured: immediately upon first assessment of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 May 2019
- Primary completion1 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LAFFONT, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402398
- Sponsor's protocol ID
- RECHMPL19_0280
- Acronym
- IMITO
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Do Khac A, Jourdan C, Fazilleau S, Palayer C, Laffont I, Dupeyron A, Verdun S, Gelis A. mHealth App for Pressure Ulcer Wound Assessment in Patients With Spinal Cord Injury: Clinical Validation Study. JMIR Mhealth Uhealth. 2021 Feb 23;9(2):e26443. doi: 10.2196/26443.
PubMed 33620327
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)
- ClinicalTrials.gov ID
- NCT04402398
- Acronym / sponsor ID
- IMITO / RECHMPL19_0280
- Conditions
- Spinal Cord Injuries
- Keywords
- Pressure ulcer, validity of measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients, providing consent for study, with complete or incomplete spinal cord injury, with pressure ulcers requiring hospital follow-up (lesion stade II to IV), followed at Centre Mutualiste Propara, rehabilitation centre, Montpellier, France
Key inclusion criteria (3 listed)
- complete or incomplete spinal cord injury, all delays or aetiologies
- presence of one or more pressure ulcers stade II to IV
- adults
Key exclusion criteria (2 listed)
- refusal to participate
- local infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure
Time frame: immediately upon first assessment of patients
Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure
3 secondary outcomes
Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure
Time frame: immediately upon first assessment of patients
inter-rater and intra-rater validity of imitoMeasure
Time frame: immediately upon first assessment of patients
Correlation of imitoMeasure of length and width of ulcers to ruler-based measures
Time frame: immediately upon first assessment of patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Derived from this study: PubMed 33620327Do Khac A, Jourdan C, Fazilleau S, Palayer C, Laffont I, Dupeyron A, Verdun S, Gelis A. mHealth App for Pressure Ulcer Wound Assessment in Patients With Spinal Cord Injury: Clinical Validation Study. JMIR Mhealth Uhealth. 2021 Feb 23;9(2):e26443. doi: 10.2196/26443.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Spinal Cord Injuries
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle LAFFONT study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure (time frame: immediately upon first assessment of patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.