Continuous Passive Motion Versus Heterotopic Ossification
Recruiting now · Not applicable
Conditions studied: Traumatic Brain Injury, Spinal Cord Injuries, Stroke
In brief
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.
Key facts
- Study ID
- NCT05906056
- Run by
- University of Ioannina
- People needed
- 20
- Starts
- 2023-05-12
- Expected to finish
- 2027-03-25
- Last updated by the study team
- 2024-12-06
Who can join
Age: 15 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.
- A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)
- A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)
- Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.
You may not qualify if…
- Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
- HO detected in another location than the hip or knee joint.
- Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
- Patients not reacting to painful stimuli
Where it is running
- Department of Physical and Rehabilitation Medicine — Ioannina, Epirus, Greece (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.