Traumatic Brain InjuryCPMversusHONCT05906056
Continuous Passive Motion Versus Heterotopic Ossification
A study testing Continuous Passive Motion (CPM), Conventional physiotherapy (PT) and Zoledronic Acid Injection in people with Traumatic Brain Injury and Spinal Cord Injuries, run by University of Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Traumatic Brain Injury, Spinal Cord Injuries, Stroke
- What is being tested?
- Continuous Passive Motion (CPM), Conventional physiotherapy (PT) and Zoledronic Acid Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 12 May 2023to 25 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.
- A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)
- A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)
- Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.
Who cannot join
- Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
- HO detected in another location than the hip or knee joint.
- Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
- Patients not reacting to painful stimuli
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Department of Physical and Rehabilitation Medicine
Ioannina, Epirus, 45110
About this study
Official title: Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
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.
Read the 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
- Being tested
- Continuous Passive Motion (CPM), Conventional physiotherapy (PT), Zoledronic Acid Injection
- Keywords
- Ossification, Heterotopic, continuous passive motion (CPM), zoledronic acid, range of motion (ROM), PROPHYLAXIS
- Medical subject headings
- Brain Injuries, Traumatic, Spinal Cord Injuries, Stroke, Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Passive Motion (CPM)Device
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)
Conventional physiotherapy (PT)Other
Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)
Zoledronic Acid InjectionDrug
one dose of intravenous zoledronic acid will be administered
| Study group | Role | What they receive |
|---|---|---|
| Continuous passive motion (CPM) | Experimental | 10 ICU patients receiving CPM at HO joints that continuously stretches slowly the joint passively at a constant velocity in a painless range and for a substantial amount of time until there is evidence both laboratory (bone alkaline phosphatase) and radiographically (CT), that osteogenesis has entered a quiescent state. Conventional PT will also be performed.
Plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made. Receives: Device: Continuous Passive Motion (CPM); Other: Conventional physiotherapy (PT); Drug: Zoledronic Acid Injection |
| Physiotherapy (PT) | Active comparator | 10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made. Receives: Other: Conventional physiotherapy (PT); Drug: Zoledronic Acid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM lost during the trial
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
Measured: According to the literature it is estimated to last approx. 70 days
HO appearance on CT
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.
Measured: According to the literature it is estimated to last approx. 70 days
Secondary outcomes (1)
Patient's Glasgow Coma Scale (GCS)
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.
Measured: According to the literature it is estimated to last approx. 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 May 2023
- Primary completion25 Apr 2026 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906056
- Sponsor's protocol ID
- CPMUIoannina
- Acronym
- CPMversusHO
- Status last verified
- Dec 2024
- First submitted
- 8 May 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12872776Vasileiadis 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.
PubMed 34310347Vasileiadis 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.
PubMed 35512120Genet F, Chehensse C, Jourdan C, Lautridou C, Denormandie P, Schnitzler A. Impact of the operative delay and the degree of neurologic sequelae on recurrence of excised heterotopic ossification in patients with traumatic brain injury. J Head Trauma Rehabil. 2012 Nov-Dec;27(6):443-8. doi: 10.1097/HTR.0b013e31822b54ba.
PubMed 22495100van Kampen PJ, Martina JD, Vos PE, Hoedemaekers CW, Hendricks HT. Potential risk factors for developing heterotopic ossification in patients with severe traumatic brain injury. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):384-91. doi: 10.1097/HTR.0b013e3181f78a59.
PubMed 21321512Citak 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.
PubMed 22614800Shehab D, Elgazzar AH, Collier BD. Heterotopic ossification. J Nucl Med. 2002 Mar;43(3):346-53.
PubMed 11884494Holguin PH, Rico AA, Garcia JP, Del Rio JL. Elbow anchylosis due to postburn heterotopic ossification. J Burn Care Rehabil. 1996 Mar-Apr;17(2):150-4. doi: 10.1097/00004630-199603000-00009.
PubMed 8675505Linan 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.
PubMed 11475483Stover SL, Hataway CJ, Zeiger HE. Heterotopic ossification in spinal cord-injured patients. Arch Phys Med Rehabil. 1975 May;56(5):199-204.
PubMed 806274
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
- ClinicalTrials.gov ID
- NCT05906056
- Acronym / sponsor ID
- CPMversusHO / CPMUIoannina
- Conditions
- Traumatic Brain Injury, Spinal Cord Injuries, Stroke
- Keywords
- Ossification, Heterotopic, continuous passive motion (CPM), zoledronic acid, range of motion (ROM), PROPHYLAXIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Continuous passive motion (CPM) | Experimental | Device: Continuous Passive Motion (CPM), Other: Conventional physiotherapy (PT), Drug: Zoledronic Acid Injection10 ICU patients receiving CPM at HO joints that continuously stretches slowly the joint passively at a constant velocity in a painless range and for a substantial amount of time until there is evidence both laboratory (bone alkaline phosphatase) and radiographically (CT), that osteogenesis has entered a quiescent state. Conventional PT will also be performed. Plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made. |
| Physiotherapy (PT) | Active comparator | Other: Conventional physiotherapy (PT), Drug: Zoledronic Acid Injection10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.
- A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)
- A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)
- Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.
Key exclusion criteria (4 listed)
- Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
- HO detected in another location than the hip or knee joint.
- Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
- Patients not reacting to painful stimuli
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Continuous passive motion (CPM) |
| Conventional physiotherapy (PT)Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU) | Other | Continuous passive motion (CPM), Physiotherapy (PT) |
| Zoledronic Acid Injectionone dose of intravenous zoledronic acid will be administered | Drug | Continuous passive motion (CPM), Physiotherapy (PT) |
Primary outcome
ROM lost during the trial
Time frame: 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
Time frame: 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.
1 secondary outcome
Patient's Glasgow Coma Scale (GCS)
Time frame: According to the literature it is estimated to last approx. 70 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 12872776Scalzitti 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.
- Background: PubMed 34310347Vasileiadis 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.
- Background: PubMed 35512120Vasileiadis 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.
- Background: PubMed 22495100Genet F, Chehensse C, Jourdan C, Lautridou C, Denormandie P, Schnitzler A. Impact of the operative delay and the degree of neurologic sequelae on recurrence of excised heterotopic ossification in patients with traumatic brain injury. J Head Trauma Rehabil. 2012 Nov-Dec;27(6):443-8. doi: 10.1097/HTR.0b013e31822b54ba.
- Background: PubMed 21321512van Kampen PJ, Martina JD, Vos PE, Hoedemaekers CW, Hendricks HT. Potential risk factors for developing heterotopic ossification in patients with severe traumatic brain injury. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):384-91. doi: 10.1097/HTR.0b013e3181f78a59.
- Background: PubMed 22614800Citak 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.
- Background: PubMed 11884494Shehab D, Elgazzar AH, Collier BD. Heterotopic ossification. J Nucl Med. 2002 Mar;43(3):346-53.
- Background: PubMed 8675505Holguin PH, Rico AA, Garcia JP, Del Rio JL. Elbow anchylosis due to postburn heterotopic ossification. J Burn Care Rehabil. 1996 Mar-Apr;17(2):150-4. doi: 10.1097/00004630-199603000-00009.
- Background: PubMed 11475483Linan 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.
- Background: PubMed 806274Stover SL, Hataway CJ, Zeiger HE. Heterotopic ossification in spinal cord-injured patients. Arch Phys Med Rehabil. 1975 May;56(5):199-204.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Passive Motion (CPM), Conventional physiotherapy (PT) and Zoledronic Acid Injection in people with Traumatic Brain Injury and Spinal Cord Injuries, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avraam Ploumis, MD, PhD (+ 30 693 2080701, aploumis@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROM lost during the trial (time frame: According to the literature it is estimated to last approx. 70 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906056, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.