An interventional study of Infrared imaging in Limping, sponsored by Sheffield Children's NHS Foundation Trust. Completed. Open to participants aged 9 Months to 16 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Sheffield Children's NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's enrollment of 30 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Sheffield Children's NHS Foundation Trust is the lead sponsor of 53 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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.
Infrared imaging of Region Of Interest in study participants
Device: Infrared imaging
Infrared image image acquisition of study participants
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
Time frame: 10 minutes
| Milestone | Infrared Imaging Undertaken |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25
| Participants | Infrared Imaging Undertaken |
|---|---|
| Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child | 30 |
Collected over Adverse event data was requested for 6 months after recruitment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infrared Imaging Undertaken | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Infrared Imaging Undertaken |
|---|---|
| <=18 years | 30 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Infrared Imaging Undertaken |
|---|---|
| Mean | 5.2 ± 3.0 |
| Sex: Female, Male(Participants) | Infrared Imaging Undertaken |
|---|---|
| Female | 10 |
| Male | 20 |
| Race and Ethnicity Not Collected(Participants) | Infrared Imaging Undertaken |
|---|
| Region of Enrollment(Participants) | Infrared Imaging Undertaken |
|---|---|
| United Kingdom | 30 |
No study locations are listed for this record.
Ran from Jan 2016 to primary completion in Jun 2016, 5 months.
Results were first posted in Apr 2019, 2 years 10 months after primary completion.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's 5 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Sheffield Children's NHS Foundation Trust