Clinique de l'Europe à Amiens
Amiens, 80090, France
NCT Number: NCT06242002
The goal of this clinical trial is to evaluate the monitoring using a sensor in patients who have undergone forefoot surgery, during the first 7 post-operative days.
The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button.
The main objective it aims to answer are:
* to evaluate the feasibility of post-operative monitoring using this tool * to evaluate the reliability of the tool
The investigators hope to determine if using this tool can be able to provide patients a "connected" personalized real-time monitoring for follow-up.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Amiens, 80090, France
Currently, patients undergoing forefoot surgery often do so in an outpatient setting and thus spend less and less time in the healthcare establishment in contact with the nursing staff, being increasingly left to themselves at home. The development of telemedicine with real-time information transfer can enable the monitoring of acute or chronic pathologies, thus allowing a link between the patient and the healthcare network, for more personalized monitoring.
Post-operative pain following forefoot surgery is now well controlled, allowing greater patient autonomy despite post-operative footwear. However, the patient's autonomy, locomotor and mobilization capacity are not known.
The investigators therefore propose monitoring the first 7 post-operative days using a sensor in patients who have undergone forefoot surgery. This 7-day period corresponds to the critical period of foot surgery with resumption of post-operative support, lifting of loco-regional anesthesia and return home. This monitoring will be done from discharge from the service until the first post-operative visit. The monitoring will be prospective with non-invasive measurements via an electronic sensor (already used for sporting activities, notably long-distance running). This will be a clinical practice study, with no modification to monitoring or current practices. The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button. The recorded parameters will be the number of steps, local temperature and GPS position of the patient. The data will be transmitted via an independent cellular network and to a secure space (username and password) accessible online.
The main objective will be to evaluate the feasibility of post-operative monitoring using this tool. The secondary objectives will be to evaluate the reliability of the tool, to evaluate the transmission of the GPS signal, and to collect the data.
Following this study, the investigators hope to be able to provide patients with real-time monitoring, via alerts received on the smartphone (e.g. icing instructions via the temperature sensor, instructions to reduce locomotor activity, etc.) .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgery is performed as usual for patients needing this medical procedure. At the end, the sensor is set up under the surgical dressing.
Time frame: Every 4 hours during 7 days
Collecting step count data on the server
Time frame: Every 4 hours during 7 days
Collecting local temperature data on the server
Time frame: Every 4 hours during 7 days
Collecting data on the distance traveled by the patient on the server, (in kilometers). Distance is measured by the global positioning system beacon of the sensor.
Time frame: day 8
Patients satisfaction will be evaluated by a questionnaire with 5 items. 4 items are "yes-no" questions, and the last one is a Likert scale of 5 levels (from "not at all satisfied" to "very satisfied").
Clinique de lEurope a Amiens
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05444192
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Glasgow, United Kingdom
View Trial DetailsNCT06086418
Ankle Disease, Ankle Injuries
Poznan, Poznań, Poland
View Trial DetailsNCT06300671
Balance Disorders, Foot Injuries
Beşiktaş, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT05323773
Ankle Injuries, Ankle Sprains
Gothenburg, Sweden
View Trial Details