Using Continuous Passive Motion to Prevent Heterotopic Ossification
Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
NA · University of Ioannina · NCT05906056
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 15 Years to 70 Years |
| Sex | All |
| Sponsor | University of Ioannina (other) |
| Locations | 1 site (Ioannina, Epirus) |
| Trial ID | NCT05906056 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ICU patients with stabilized conditions suffering from traumatic brain injury, stroke, or spinal cord injuries.
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.
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 performed: While the use of CPM has been explored in various contexts, this specific application for preventing HO in neurogenic ICU patients is relatively novel.
Eligibility criteria
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 this trial is running
Ioannina, Epirus
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Spinal Cord Injuries, Stroke, Ossification, Heterotopic, continuous passive motion, zoledronic acid, range of motion, PROPHYLAXIS