High Resolution IR Imaging for Diagnosis in the Acute Limping Child - ThermLimp

NCT03312348 | Completed Results

• 1 other identifier: SCH-13-067C
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

A variety of different diseases may cause a limp in a child, and in younger children it is particularly challenging to isolate the area affected. Children of this age group are unable to identify a specific region of pain, so clinical examination and parental interpretation is the only method of localising the area of discomfort. Potential problems that may affect children include inflammation, fractures, infection, juvenile arthritis or movement in the growth plate in the hip, among other diseases. Aside from an obvious source of injury, it is challenging for a clinician to distinguish between these different potential causes or the area of the problem without repeated visits, non-specific blood tests and the use of x-ray imaging: a form of radiation that carries with it a small risk of carcinogenic effect. Once a region of the lower limb is identified, an x-ray image of the affected area is often taken; however, it is not possible to image the entire leg, so the importance of the initial examination by a clinician is evident. The aim of this research project is to assess the potential of high resolution infrared (IR) imaging technology in the identification of a focus for the cause of a limping child. The IR camera used for imaging is able to observe an entire limb, so the need to localise an area for imaging would be removed. In addition, if successful, infrared imaging could reduce the number of children exposed to x-ray radiation unnecessarily, whilst stream-lining medical practice by reducing the time to make a diagnosis along with unnecessary visits and tests. The investigators aim to explore whether non-invasive IR thermographic camera imaging assists with the clinical diagnosis in children presenting with an acute limp. This study represents a pilot evaluation as a test of concept.

Conditions

Limping

Outcome Measures

Primary Outcomes (1)

• Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child

  Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25

  10 minutes

Study Arms (1)

Infrared Imaging undertaken

EXPERIMENTAL

Infrared imaging of Region Of Interest in study participants

Device: Infrared imaging

Interventions

Infrared imaging DEVICE

Infrared image image acquisition of study participants

Infrared Imaging undertaken

Eligibility Criteria

• Age: 9 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Children with multiple injuries (e.g. those involved in serious car accidents), or those who have difficulty understanding the nature of the study (e.g. non-native English speakers, those with disabilities impairing their understanding of the study etc.) will be excluded. Patients/carers in whom consent has not been obtained or refused will also be excluded.
• Children who attend the ED with safeguarding concerns or in whom child protection suspicions arise during the consultation will be excluded. These children have a separate assessment process which would be significantly different to the study cohort.

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Shammi Ramlakhan - Chief Investigator
• Organization: Sheffield Children's NHS Trust

shammi.ramlakhan@sch.nhs.uk

+44 1142262331

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 30, 2016
• Last Updated: January 22, 2021
• Results First Posted: April 24, 2019

Record last verified: 2021-01