|- candidate number||8700|
|- NTR Number||NTR2629|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2010|
|- Secondary IDs||335020004 ZonMw|
|- Public Title||Fracturerehabilitation.|
|- Scientific Title||Fracturehealing in major trauma patients (telemonitoring with a pressuresensor in the shoe), Feetb@ck.|
|- hypothesis||The aim of this programm is to stimulate people to follow the medical instructions and therefore to optimise the rehabilitation process and the bonehealing.
In this project a prototypes was fabricated and will be used in twenty patients with a specific type of lower extremity fracture to investigate the use of the technical device.
|- Healt Condition(s) or Problem(s) studied||Fracture , Lower extremity, Caregiver burden, Pressure parameters|
|- Inclusion criteria||Fracture of the lower extremity.|
|- Exclusion criteria||1. Not able to communicate in Dutch;|
2. Not instructable;
3. Without an address.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-sep-2011|
|- Target number of participants||30|
|- Interventions||With a special communication device and an in-shoe pressure sensor beneath the foot, data will be collected and sent to a central database. Pressure data provides information about the amount of steps, the axial pressure beneath the leg, and caregivers are able to provide feedback to the patients. Usual care is subjective 'time writing', but with this method objective data are available about load.|
|- Primary outcome||1. Bouts of axial dynamic loading;|
2. Number of dynamic loadings;
3. Average amplitude;
4. Duration per unit of time.
|- Secondary outcome||1. Convenience;|
For these measurements questionnaires are used.
|- Timepoints||During twelve weeks real-time monitoring.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Charlotte Gardeniers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. H.R. Holtslag|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Evalan BV|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Feetb@ck supports fracture rehabilitation by collecting pressure measurements and transform them into specific parameters, easy to use for health care givers. Real-time monitoring is possible by using a communication device and an in-shoe plantar pressure measurement sensor. Data is collected and stored at a central database. Information about the amount of steps and axial pressure are helpful for caregivers to give feedback to the patients by phone. With this objective method it is easier to show the patient load and load.|
In this project prototypes are made and will be used by 20 different patients with a lower leg fracture. The aim is to test the applicability of this concept. Using a website makes it possible for patients as well as care-givers to follow the patient. It might be possible to give insight into their activity level and to compare it with people of their age and gender. The advantage for the patient is that they don't have to travel to the hospital.
The multidisciplinary projectteam has already performed some research in this field of fracture rehabilitation and we are eager to share the results with others.
|- Main changes (audit trail)|
|- RECORD||24-nov-2010 - 27-dec-2010|