Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial: Initiating Early Acute Cycling Within the First Days After Spinal Cord Injury to Decrease Complications and Improve Neurofunctional Recovery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 主要终点
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
Spinal cord injuries (SCI) are among the most catastrophic survivable events experienced by human beings. Affected individuals remain with lifelong neurological impairment involving motor, sensory, bladder and bowel functions, which in turn impacts quality of life and independence. Currently, patients have no access to exercise therapy for weeks to months after the injury because clinicians remain fearful that early initiation of exercise therapy may be harmful to patients, and could lead to neurological deterioration. Patients are therefore mostly immobilized during the first weeks after the injury, and are at high risk of complications associated with immobility. In addition, there are compelling preclinical evidence showing that early exercise therapy is effective for promoting neurofunctional recovery. The PROMPT-SCI trial was the first to initiate early exercise therapy in the form of in-bed leg cycling within days after SCI. This trial has shown that it is safe and does not lead to neurological deterioration. However, in-bed leg cycling remains difficult to translate into the clinical environment of acute SCI, and its potential to decrease complications and improve neurofunctional recovery seems limited by the positioning in bed. The PROMPT-SCI II trial will therefore evaluate the potential of sitting leg cycling initiated within the first week of a SCI to decrease complications and improve neurofunctional recovery up to one year after the injury, in comparison to our prior data obtained with early in-bed cycling.
详细描述
BACKGROUND: A severe traumatic spinal cord injury (SCI) leads to permanent sensorimotor neurological deficits. During acute care, patients are mostly immobilized due to pain (from injuries and surgeries) and inherent paralysis from the SCI, resulting in complications such as pneumonia, pressure injuries, deconditioning, etc. There is also compelling preclinical evidence showing that early immobilization after SCI impairs the capacity of the nervous system to reorganize and promote neurological recovery. The PROMPT-SCI trial was the first to perform a clinical trial of early acute exercise therapy in the form of in-bed leg cycling starting within 5 days of a SCI, leading to these findings: 1) no adverse events associated with cycling, 2) decreased rates of complications, and 3) activation of paralyzed muscles triggered by cycling. Unfortunately, the PROMPT-SCI trial failed to demonstrate neurofunctional benefits similar to those observed in preclinical studies, potentially due to the short 2-week duration of the intervention, and to insufficient tactile and proprioceptive feedback in lower extremities with in-bed cycling, which could be circumvented by performing seated cycling throughout the entire acute care.
GOALS: This longitudinal cohort study will investigate the feasibility and clinical benefits of early acute seated cycling on neurofunctional recovery and complications. The hypotheses are:
H1: There will be no serious adverse events; 80% of participants will complete a first session within 5 days of the SCI and at least 80% of all planned sessions thereafter.
H2: Complication rates will be decreased for pneumonia, urinary tract infection and pressure injuries.
H3: Neurofunctional recovery will be improved 1 year after the SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 years or older with non-penetrating traumatic SCI
- •SCI severity AIS grade A (complete injury with no motor or sensory function below lesion), B (sensory but no motor function preserved) or C (motor function preserved with most key muscles unable to move against gravity)
- •NLI between C0 and L2; and spine surgery performed within 48 hours of SCI
排除标准
- •intubated and mechanically ventilated
- •conditions interfering with patient safety or ability to undergo cycling
- •body mass index 40 kg/m2 or less (to prevent "frog leg" position during cycling)
- •moderate or severe traumatic brain injury
- •hemodynamic instability
- •pelvic or lower extremity
- •injury with weight-bearing or mobilization restrictions
研究组 & 干预措施
activity-based therapy
leg cycling
干预措施: activity-based therapy (Procedure)
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
时间窗: perioperatively/periprocedurally
Adverse events including changes in blood pressure, heart rate, oxygen saturation, etc.
Complications
时间窗: perioperatively/periprocedurally
Acute complications including pneumonia, urinary tract infection, pressure injury, spasticity, etc.
次要结局
- Score from Item 14 of the Spinal Cord Independence Measure ranging from 0 to 8(1 year)
- Presence or absence of improvement in motor score by 5 points from baseline to 1 year(1 year)
- Presence or absence of improvement in sensory scores by 10 points from baseline to 1 year(1 year)
- Presence or absence of an improvement by one American Spinal Injury Association Impairment Scale grade from baseline to 1 year(1 year)
- Total score of Spinal Cord Independence Measure ranging from 0 to 100(1 year)
- Frequence of spasms from Penn Spasm Frequency Scale ranging from 0 to 4(1 year)
- Spasticity severity from Spinal Cord Assessment Tool for Spastic Reflexes ranging from 0 to 3(1 year)
- Presence or absence of neuropathic pain(1 year)
- Physical component score from Short-form 36 ranging from 0 to 100(1 year)
- Presence or absence of improvement by 2 neurological levels of injury from baseline to 1 year(1 year)
- Mental component score from Short-form 36 ranging from 0 to 100(1 year)
研究者
Jean-Marc Mac-Thiong
Professor of Surgery
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal