Early and Intensive Motor Training for people with spinal cord injuries (the SCI-MT Trial): protocol of the process evaluation.

INTRODUCTION: People with spinal cord injury receive physical rehabilitation to promote neurological recovery. Physical rehabilitation commences as soon as possible when a person is medically stable. One key component of physical rehabilitation is motor training. There is initial evidence to suggest that motor training can enhance neurological recovery if it is provided soon after injury and in a high dosage. The Early and Intensive Motor Training Trial is a pragmatic randomised controlled trial to determine whether 10 weeks of intensive motor training enhances neurological recovery for people with spinal cord injury. This pragmatic randomised controlled trial will recruit 220 participants from 15 spinal injury units in Australia, Scotland, Italy, Norway, England, Belgium and the Netherlands. This protocol paper describes the process evaluation that will run alongside the Early and Intensive Motor Training Trial. This process evaluation will help to explain the trial results and explore the potential facilitators and barriers to the possible future rollout of the trial intervention. METHODS AND ANALYSIS: The UK Medical Research Council process evaluation framework and the Implementation Research Logic Model will be used to explain the trial outcomes and inform future implementation. Key components of the context, implementation and mechanism of impact, as well as the essential elements of the intervention and outcomes, will be identified and analysed. Qualitative and quantitative data will be collected and triangulated with the results of the Early and Intensive Motor Training Trial to strengthen the findings of this process evaluation. ETHICS AND DISSEMINATION: Ethical approval for the Early and Intensive Motor Training Trial and process evaluation has been obtained from the Human Research Ethics Committee at the Northern Sydney Local Health District (New South Wales) in Australia (project identifier: 2020/ETH02540). All participants are required to provide written consent after being informed about the trial and the process evaluation. The results of this process evaluation will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trial Registry (ACTRN12621000091808); Universal Trial Number (U1111-1264-1689).

Early and intensive motor training to enhance neurological recovery in people with spinal cord injury: trial protocol.

STUDY DESIGN: Protocol for a multi-centre randomised controlled trial (the SCI-MT trial). OBJECTIVES: To determine whether 10 weeks of intensive motor training enhances neurological recovery in people with recent spinal cord injury (SCI). SETTING: Fifteen spinal injury units in Australia, Scotland, England, Italy, Netherlands, Norway, and Belgium. METHODS: A pragmatic randomised controlled trial will be undertaken. Two hundred and twenty people with recent SCI (onset in the preceding 10 weeks, American Spinal Injuries Association Impairment Scale (AIS) A lesion with motor function more than three levels below the motor level on one or both sides, or an AIS C or D lesion) will be randomised to receive either usual care plus intensive motor training (12 h of motor training per week for 10 weeks) or usual care alone. The primary outcome is neurological recovery at 10 weeks, measured with the Total Motor Score from the International Standards for Neurological Classification of SCI. Secondary outcomes include global measures of motor function, ability to walk, quality of life, participants' perceptions about ability to perform self-selected goals, length of hospital stay and participants' impressions of therapeutic benefit at 10 weeks and 6 months. A cost-effectiveness study and process evaluation will be run alongside the trial. The first participant was randomised in June 2021 and the trial is due for completion in 2025. CONCLUSIONS: The findings of the SCI-MT Trial will guide recommendations about the type and dose of inpatient therapy that optimises neurological recovery in people with SCI. TRIAL REGISTRATION: ACTRN12621000091808 (1.2.2021).

Early clinical predictors of pneumonia in critically ill spinal cord injured individuals: a retrospective cohort study.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: Pneumonia is the dominant complication following traumatic spinal cord injury (SCI) and profoundly impacts morbidity by prolonging length of stay and worsening neurological outcome. The aims of this study were to determine the key predictors of clinically important pneumonia (CIP); and to examine the impact of CIP on resource utilisation in critically ill acute traumatic SCI individuals between 2010 and 2015. SETTING: Alfred and Austin Hospitals (Melbourne, Australia). METHODS: Data were extracted from the medical records of 93 cases of acute traumatic SCI resulting in ISNCSCI C3-L1 level of injury requiring admission to the intensive care unit and aged between 15 and 70 years. Patients with life-threatening injuries, not requiring spinal surgery, palliated within 7 days of injury, diagnosis of traumatic central cord syndrome or with poor general health, were excluded. RESULTS: A total of 33 episodes of CIP were observed. Median time to CIP diagnosis was 65 h (IQR: 42-93) and median time to spinal surgery was 22 h (IQR: 12-32). Four key predictors were identified; male gender (OR: 18.3, CI: 1.9-174.9, p = 0.001), motor complete injury (OR: 10.1, CI: 1.1-92.1, p = 0.011), presence of chest trauma (OR: 4.5, CI: 1.4-14.4, p = 0.007) and delayed intubation (HR: 6.8, CI: 1.6-28.6, p = 0.009). CONCLUSIONS: This study identifies four key predictors involved in elevated pneumonia risk; male gender, motor complete injury, presence of chest trauma and delayed intubation, enabling the future synthesis of a pneumonia prediction tool for use in the acute postinjury period.

Early Spinal Surgery Following Thoracolumbar Spinal Cord Injury: Process of Care From Trauma to Theater.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: The aims of this study were to (1) determine the timing of surgery for traumatic thoracolumbar spinal cord injury (TLSCI) between 2010 and 2014 and (2) identify major delays in the process of care from accident scene to surgery. SUMMARY OF BACKGROUND DATA: Early spinal surgery may promote neurological recovery and reduce acute complications after TLSCI; however, it is difficult to achieve due to logistical issues and the frequent presence of other nonlife-threatening injuries. METHODS: Data were extracted from the medical records of 46 cases of acute traumatic TLSCI (AIS level T1-L1) aged between 15 and 70 years. Patients with life-threatening injuries, not requiring spinal surgery or with poor general health, were excluded. RESULTS: The median time to surgery was 27 hours [interquartile range (IQR): 20-43 hours] and improved from 27 hours in 2010 to 22 hours in 2014. Cases admitted via a pre-surgical hospital had a longer median time to surgery than direct surgical hospital admissions (28 vs. 24 hours, respectively). The median time from completion of radiological investigations to surgery was 18 hours, suggesting that theater access and organization of a surgical team were the major factors contributing to surgical delay. Number of vertebral levels fractured (≥5) and upper thoracic level of injury (T1-8) were also found to be associated with surgical delay. CONCLUSION: Earlier spinal surgery in TLSCI would be facilitated by direct surgical hospital admission and improved access to the operating theater and surgical teams. LEVEL OF EVIDENCE: 3.

Early Rapid Neurological Assessment for Acute Spinal Cord Injury Trials.

Clinical trials evaluating early therapies after spinal cord injury (SCI) are challenging because of the absence of a rapid assessment. The aim of this study was to determine whether the severity and level of SCI could be established from a brief neurological assessment capable of being used in an emergency setting. A brief assessment called the SPinal Emergency Evaluation of Deficits (SPEED) was developed and retrospectively evaluated in a cohort of 118 patients with SCI. Foot motor and sensory function was used to indicate injury severity. C3 dermatome sensation, handgrip strength and location of spinal pain were used to indicate the level of injury. With regard to injury severity, a high proportion of patients (94%) with no foot movement at the time of injury were initially diagnosed as motor complete (American Spinal Injury Association Impairment Scale [AIS] grade A-B), whereas all patients with foot movement were identified as motor incomplete (AIS grade C-D). This was reflected by a good correlation (rs = 0.79) and agreement (κ = 0.85) between the SPEED motor score and the acute hospital assessment. With respect to injury level, the majority of cases with cervical SCI (92%) had no or weak handgrip at the time of paramedic assessment, whereas all cases with thoracolumbar SCI had a strong handgrip. The location of spinal pain was also in accordance with the level of spinal injury. The SPEED assessment appears capable of accurately determining the severity and level of cervical SCI in the first hours post-injury. A neurological assessment that can be performed rapidly after injury is important for clinical trials of early therapy and to identify patients most likely to benefit from intervention.

Early Decompression following Cervical Spinal Cord Injury: Examining the Process of Care from Accident Scene to Surgery.

Early decompression may improve neurological outcome after spinal cord injury (SCI), but is often difficult to achieve because of logistical issues. The aims of this study were to 1) determine the time to decompression in cases of isolated cervical SCI in Australia and New Zealand and 2) determine where substantial delays occur as patients move from the accident scene to surgery. Data were extracted from medical records of patients aged 15-70 years with C3-T1 traumatic SCI between 2010 and 2013. A total of 192 patients were included. The median time from accident scene to decompression was 21 h, with the fastest times associated with closed reduction (6 h). A significant decrease in the time to decompression occurred from 2010 (31 h) to 2013 (19 h, p = 0.008). Patients undergoing direct surgical hospital admission had a significantly lower time to decompression, compared with patients undergoing pre-surgical hospital admission (12 h vs. 26 h, p < 0.0001). Medical stabilization and radiological investigation appeared not to influence the timing of surgery. The time taken to organize the operating theater following surgical hospital admission was a further factor delaying decompression (12.5 h). There was a relationship between the timing of decompression and the proportion of patients demonstrating substantial recovery (2-3 American Spinal Injury Association Impairment Scale grades). In conclusion, the time of cervical spine decompression markedly improved over the study period. Neurological recovery appeared to be promoted by rapid decompression. Direct surgical hospital admission, rapid organization of theater, and where possible, use of closed reduction, are likely to be effective strategies to reduce the time to decompression.