Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ROM lost during the trial
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
CT will not reveal the group of patient's origin to the reader
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 Tc
- •(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.
排除标准
- •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
研究组 & 干预措施
Continuous passive motion (CPM)
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.
干预措施: Continuous Passive Motion (CPM) (Device)
Continuous passive motion (CPM)
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.
干预措施: Conventional physiotherapy (PT) (Other)
Continuous passive motion (CPM)
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.
干预措施: Zoledronic Acid Injection (Drug)
Physiotherapy (PT)
10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.
干预措施: Conventional physiotherapy (PT) (Other)
Physiotherapy (PT)
10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.
干预措施: Zoledronic Acid Injection (Drug)
结局指标
主要结局
ROM lost during the trial
时间窗: 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
时间窗: 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.
次要结局
- Patient's Glasgow Coma Scale (GCS)(According to the literature it is estimated to last approx. 70 days)
研究者
Avraam Ploumis
Professor of Phyical and Rehabilitation Medicine
University of Ioannina