LimpingThermlimpNCT03312348
High Resolution IR Imaging for Diagnosis in the Acute Limping Child - ThermLimp
A study testing Infrared imaging in people with Limping, run by Sheffield Children's NHS Foundation Trust.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 months to 16 years
- Conditions the study is for
- Limping
- What is being tested?
- Infrared imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 9 months -16 years old who attend the Emergency Department (ED) of the Sheffield Children's Hospital for an acute (less than 48 hours) limp. Inclusion is subject to both the patient and carer having read (or being read to in very young children) the information sheets and both the patient and carer consenting to participate.
Who cannot join
- 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.
About this study
Official title: High Resolution Infrared Thermographic Imaging as a Diagnostic Aid for Acute Undifferentiated Limp in Children.
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
- Being tested
- Infrared imaging
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared imagingDevice
Infrared image image acquisition of study participants
| Study group | Role | What they receive |
|---|---|---|
| Infrared Imaging undertaken | Experimental | Infrared imaging of Region Of Interest in study participants Receives: Device: Infrared imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study startJan 2016
- Primary completionJun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LimpingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312348
- Sponsor's protocol ID
- SCH-13-067C
- Acronym
- Thermlimp
- Status last verified
- Jan 2021
- First submitted
- 12 Oct 2017
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Infrared Thermographic Imaging as a Diagnostic Aid for Acute Undifferentiated Limp in Children.
- ClinicalTrials.gov ID
- NCT03312348
- Acronym / sponsor ID
- Thermlimp / SCH-13-067C
- Conditions
- Limping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Posted 24 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infrared Imaging undertaken | Experimental | Device: Infrared imagingInfrared imaging of Region Of Interest in study participants |
Who may qualify
- Ages
- 9 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children age 9 months -16 years old who attend the Emergency Department (ED) of the Sheffield Children's Hospital for an acute (less than 48 hours) limp. Inclusion is subject to both the patient and carer having read (or being read to in very young children) the information sheets and both the patient and carer consenting to participate.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared imagingInfrared image image acquisition of study participants | Device | Infrared Imaging undertaken |
Primary outcome
Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child
Time frame: 10 minutes
Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared imaging in people with Limping, run by Sheffield Children's NHS Foundation Trust.
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 1 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.