NCT05906056Recruiting
Continuous Passive Motion Versus Heterotopic Ossification
Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 8 May 2023
- Start date
- 12 May 2023
- Primary completion date
- 25 Apr 2026
- Lead sponsor
- University of Ioannina
- Diseases
- Stroke
- NCT number
- NCT05906056
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 12 May 2023 to the primary completion date, 25 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
Lab values
- Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
Other
- HO detected in another location than the hip or knee joint.
- Patients not reacting to painful stimuli
Who the study is looking for
- 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.
Age in the registry: 15 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Physical and Rehabilitation Medicine Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.