Clinical trial NCT05906056: Continuous Passive Motion Versus Heterotopic Ossification
Official title: Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Spinal Cord Injuries
Stroke
Keywords: Ossification, Heterotopic
continuous passive motion (CPM)
zoledronic acid
range of motion (ROM)
PROPHYLAXIS
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: ROM lost during the trial
timeFrame: According to the literature it is estimated to last approx. 70 days
measure: HO appearance on CT
timeFrame: According to the literature it is estimated to last approx. 70 days
Secondary outcomes:
measure: Patient's Glasgow Coma Scale (GCS)
timeFrame: According to the literature it is estimated to last approx. 70 days
Other outcomes:
Locations:
city: Ioánnina
country: Greece
facility: Department of Physical and Rehabilitation Medicine
state: Epirus
Study officials:
References:
citation: Scalzitti DA. Because of the risk of developing heterotopic ossification, are passive range of motion exercises contraindicated following traumatic injuries? Phys Ther. 2003 Jul;83(7):659-7. No abstract available.
citation: Vasileiadis GI, Varvarousis DN, Manolis I, Ploumis A. The Impact of Continuous Passive Motion on Heterotopic Ossification Maturation. Am J Phys Med Rehabil. 2021 Dec 1;100(12):e194-e197. doi: 10.1097/PHM.0000000000001852.
citation: Vasileiadis GI, Balta AA, Zerva A, Kontogiannopoulos V, Varvarousis DN, Dimakopoulos G, Ploumis A. Role of Kinesiotherapy in the Prevention of Heterotopic Ossification: A Systematic Review. Am J Phys Med Rehabil. 2023 Feb 1;102(2):110-119. doi: 10.1097/PHM.0000000000002043. Epub 2022 Apr 28.
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citation: Citak M, Suero EM, Backhaus M, Aach M, Godry H, Meindl R, Schildhauer TA. Risk factors for heterotopic ossification in patients with spinal cord injury: a case-control study of 264 patients. Spine (Phila Pa 1976). 2012 Nov 1;37(23):1953-7. doi: 10.1097/BRS.0b013e31825ee81b.
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citation: Linan E, O'Dell MW, Pierce JM. Continuous passive motion in the management of heterotopic ossification in a brain injured patient. Am J Phys Med Rehabil. 2001 Aug;80(8):614-7. doi: 10.1097/00002060-200108000-00013.
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