Department of Physical and Rehabilitation Medicine
Ioannina, Epirus, 45110, Greece
Location status: Recruiting
NCT Number: NCT05906056
The investigators hypothesize that Heterotopic Ossification (HO) formation can be suppressed if the application of a Continuous Passive Motion (CPM) device can be performed for a substantial amount of time. The investigators will use the following study design: a pilot study with 10 ICU patients receiving CPM and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. The comparison between the treatment and referent groups of the outcomes will prove the prophylactic power of CPM against HO.
Interested in participating?
Request Info15 year–70 year
All sexes
Interventional
Not applicable
Ioannina, Epirus, 45110, Greece
Location status: Recruiting
The aim of this study is to formally evaluate whether the investigators can indeed prevent HO by the timely and painless use of CPM in neurogenic intensive care unit (ICU) patients with stabilized medical conditions, suffering from neurological insults either traumatic brain injury (TBI), stroke, or Spinal Cord Injury (SCI). The investigators hypothesize that HO formation can be suppressed if CPM can be performed for a substantial amount of time. The investigators will perform a pilot study with 10 ICU patients receiving CPM and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study. The primary outcomes will be the CT appearance of HO in the hip or knee joint and the degree of ROM limitation in the given joint at baseline and at the end of the clinical trial. A secondary outcome that will be measured, will be the Glasgow Coma Scale (GCS) at the beginning and at the end of the CPM program. The comparison between the treatment and referent groups in terms of these outcomes will prove the prophylactic power of CPM against HO.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CPM uses machines to move a joint passively i.e. without the patient exerting any effort. A motorized device moves the joint repetitively to a set of degrees and movement speed, determined by the caregiver either a medical doctor (physiatrist or orthopedic surgeon) or a physiotherapist. Its action preserves the joint's range of motion (ROM)
Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)
one dose of intravenous zoledronic acid will be administered
Time frame: According to the literature it is estimated to last approx. 70 days
The difference in ROM between the measurements at baseline and at the end of the The program will last until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state. prophylactic program
Time frame: According to the literature it is estimated to last approx. 70 days
Based on Brooker HO classification method (between I and IV with IV being bridging bone and joint ankylosis), the difference in CT appearance at baseline and at the end of the program will serve as a descriptive tool. Until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state.
Time frame: According to the literature it is estimated to last approx. 70 days
Calculation of GCS (range 0-15 with 15 being the normal) at the beginning and at the end of the CPM program.Until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state.
Contact information is provided by the study sponsor or research team.
Avraam Ploumis, MD, PhD
CONTACT
George I Vasileiadis, MD, PhD
CONTACT
University of Ioannina
Other
Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
Acronym: CPMversusHO
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