NCT05906056 Continuous Passive Motion Versus Heterotopic Ossification
| NCT ID | NCT05906056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ioannina |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-05-12 |
| Primary Completion | 2026-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-05-12 with a primary completion date of 2026-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05906056 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 70 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05906056 currently recruiting?
Yes, NCT05906056 is actively recruiting participants. Contact the research team at aploumis@uoi.gr for enrollment information.
Where is the NCT05906056 trial being conducted?
This trial is being conducted at Ioannina, Greece.
Who is sponsoring the NCT05906056 clinical trial?
NCT05906056 is sponsored by University of Ioannina. The trial plans to enroll 20 participants.