Spinal Cord Injuries, Stroke, Traumatic Brain Injury
Conditions
Keywords
Ossification, Heterotopic, continuous passive motion (CPM), zoledronic acid, range of motion (ROM), PROPHYLAXIS
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.
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.
Interventions
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)
OTHERConventional physiotherapy (PT)
Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)
one dose of intravenous zoledronic acid will be administered
Sponsors
University of Ioannina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
CT will not reveal the group of patient's origin to the reader
Intervention model description
randomized control trial
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ROM lost during the trial | According to the literature it is estimated to last approx. 70 days | The difference in ROM between the measurements at baseline and at the end of the The program will last until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state. prophylactic program |
| HO appearance on CT | According to the literature it is estimated to last approx. 70 days | Based on Brooker HO classification method (between I and IV with IV being bridging bone and joint ankylosis), the difference in CT appearance at baseline and at the end of the program will serve as a descriptive tool. Until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Glasgow Coma Scale (GCS) | According to the literature it is estimated to last approx. 70 days | Calculation of GCS (range 0-15 with 15 being the normal) at the beginning and at the end of the CPM program.Until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state. |
Countries
Greece
Contacts
Primary ContactAvraam Ploumis, MD, PhD
Backup ContactGeorge I Vasileiadis, MD, PhD
Outcome results
None listed