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Temperature measurements in trauma patients with a fracture of the lower extremities in the rehabilitation phase.


- candidate number22775
- NTR NumberNTR5373
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-aug-2015
- Secondary IDs15-N-137a METC Heerlen
- Public TitleTemperature measurements in trauma patients with a fracture of the lower extremities in the rehabilitation phase.
- Scientific TitleMeasuring temperature at the height of the ankle in trauma patients with a fracture of the lower extremities.
- ACRONYMtempfracture
- hypothesisInvestigate whether it is possible to reliably measure the temperature of the lower extremities by means of a temperature sensor on both ankles of the rehabilitants and follow the temperature longitudinally through time. An increase in temperature at the height of the ankle is a sign of overload and requires adaptation of the rehabilitation program.
- Healt Condition(s) or Problem(s) studiedTrauma , Fracture , Lower extremity, Temperature
- Inclusion criteriaTrauma patients with fractures of the lower extremities, including pelvic fractures.
- Exclusion criteriaAmputation patients (thigh,leg,foot) and bilateral fracture of the lower extremities.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-okt-2015
- planned closingdate1-okt-2016
- Target number of participants20
- InterventionsOne sensor per leg will be placed at the height of the ankle of both legs on trauma patients who have had a fracture of the lower extremities.
- Primary outcomeThe difference in temperature measured between the affected and unaffected leg.
- Secondary outcomeComplication
- TimepointsAt the end of the day the temperature will be measured. If there is an increase in temperature and the patient is having complaints, the rehabilitation program will be adapted.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMsc Pishtiwan Kalmet
- CONTACT for SCIENTIFIC QUERIESMsc Pishtiwan Kalmet
- Sponsor/Initiator Netwerk Acute care Limburg Maastricht , Adelante Centre of Expertise in Rehabilitation and Audiology
- Funding
(Source(s) of Monetary or Material Support)
Netwerk Acute care Limburg Maastricht, Adelante Rehabilitation centre Hoensbroek
- Publications
- Brief summaryAt the moment of writing there is no information in the literature about the temperature in the affected limb in trauma patients with a fracture of the lower extremities. It is unknown if there is a variation in temperature over time in patients with a fracture of the lower extremities that have permissive weight bearing. Patients who have had a fracture of the lower extremities are at risk of overload during early mobilization. It is conceivable that pressure or overpressure causes a change of temperature in the affected limb. However, there are no known studies that substantiate this, most likely because there is currently no system that easily ambulatory measures the temperature. The ambulatory measurement of the temperature during the rehabilitation process could give more insight into the consequences of load or overload of the affected leg. To do this in the future we will develop an ambulatory measurement system consisting of a temperature sensor that can be worn around the ankle. Can we demonstrate differences in temperature of the part relative to contralateral side? Is this inflammatory response useful as feedback for patients and therapists to better individualize the weight bearing? This study is designed to see if it is possible to reliably measure the temperature of the skin at the height of the ankles during weight bearing. The study population is trauma patients with a fracture of the lower extremities that are clinically admitted in Adelante Rehabilitation Centre.
- Main changes (audit trail)
- RECORD20-aug-2015 - 28-okt-2015


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