Tests a motion device to prevent abnormal bone growth after brain or spinal injury
Tests a moving device to prevent bone growth in ICU patients with injuries.
Plain-language title generated from the registry record
Registry title: Continuous Passive Motion Versus Heterotopic Ossification
Key facts
- Where
- Ioannina, GreeceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 70 years old?
Source: NCT05906056, who can take part
Where in Greece
- Department of Physical and Rehabilitation MedicineIoannina, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Ioannina
- Trial code
- NCT05906056
- Record updated
- 6 December 2024
- Original description
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.Read full original descriptionShow less
Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
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.
Inclusion: 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.
Exclusion: Life-threatening conditions that render Continuous passive motion (CPM) application difficult; Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level; HO detected in another location than the hip or knee joint; Patients not reacting to painful stimuli.