NCT05906056

Continuous Passive Motion Versus Heterotopic Ossification

Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Ioannina · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of this study is to formally evaluate whether the investigators can indeed prevent HO by the timely and painless use of CPM in neurogenic intensive care unit (ICU) patients with stabilized medical conditions, suffering from neurological insults either traumatic brain injury (TBI), stroke, or Spinal Cord Injury (SCI). The investigators hypothesize that HO formation can be suppressed if CPM can be performed for a substantial amount of time. The investigators will perform 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 primary outcomes will be the CT appearance of HO in the hip or knee joint and the degree of ROM limitation in the given joint at baseline and at the end of the clinical trial. A secondary outcome that will be measured, will be the Glasgow Coma Scale (GCS) at the beginning and at the end of the CPM program. The comparison between the treatment and referent groups in terms of these outcomes will prove the prophylactic power of CPM against HO.

Conditions

• Traumatic Brain Injury
• Spinal Cord Injuries
• Stroke

Interventions

Type	Name	Description
DEVICE	Continuous Passive Motion (CPM)	CPM uses machines to move a joint passively i.e. without the patient exerting any effort. A motorized device moves the joint repetitively to a set of degrees and movement speed, determined by the caregiver either a medical doctor (physiatrist or orthopedic surgeon) or a physiotherapist. Its action preserves the joint's range of motion (ROM)
OTHER	Conventional physiotherapy (PT)	Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)
DRUG	Zoledronic Acid Injection	one dose of intravenous zoledronic acid will be administered

Timeline

• Start date: 2023-05-12
• Primary completion: 2026-04-25
• Completion: 2027-03-25
• First posted: 2023-06-15
• Last updated: 2024-12-06

Locations

1 site across 1 country: Greece