Using Continuous Passive Motion to Prevent Heterotopic Ossification
Official title: Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
Run by University of Ioannina · NCT05906056 · Data updated 2026-11-12
This study is trying out a special movement therapy to see if it helps prevent bone growth problems in ICU patients with brain or spinal injuries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years to 70 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Ioannina Academic / other |
| Locations | 1 site (Ioannina, Epirus) |
| Status | Recruiting |
| Started | May 12, 2023 |
| Main results expected | April 25, 2026 |
| Study ends | March 25, 2027 |
| Registry record updated | December 6, 2024 |
| Trial ID | NCT05906056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are ICU patients with stabilized conditions suffering from traumatic brain injury, stroke, or spinal cord injuries.
✕Probably not a fit
Patients with life-threatening conditions or those with HO in locations other than the hip or knee joint may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the effectiveness of Continuous Passive Motion (CPM) in preventing Heterotopic Ossification (HO) in ICU patients with neurological injuries such as traumatic brain injury, spinal cord injuries, or stroke. The study will involve 10 patients receiving CPM compared to 10 matched patients undergoing conventional physiotherapy. Primary outcomes will include the presence of HO in the hip or knee joint as assessed by CT scans and the degree of range of motion limitation. Additionally, the Glasgow Coma Scale will be measured to assess neurological status before and after the intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of Heterotopic Ossification in patients recovering from severe neurological injuries.
How similar studies have gone: While the use of CPM has been explored in various contexts, this specific application for preventing HO in neurogenic ICU patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury. 2. A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT) 3. A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.) 4. Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion. Exclusion Criteria: 1. Life-threatening conditions that render Continuous passive motion (CPM) application difficult. 2. HO detected in another location than the hip or knee joint. 3. Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level. 4. Patients not reacting to painful stimuli
Where it's running
-
Department of Physical and Rehabilitation Medicine
Ioannina, Epirus, Greece Recruiting
Study contacts
- Study coordinator: Avraam Ploumis, MD, PhD
- Email: aploumis@uoi.gr
- Phone: + 30 693 2080701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.