scholarly journals Protocol for rapid onset of mobilisation in patients with traumatic spinal cord injury (PROMPT-SCI) study: a single-arm proof-of-concept trial of early in-bed leg cycling following acute traumatic spinal cord injury

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e049884
Author(s):  
Jean-Marc Mac-Thiong ◽  
Andreane Richard-Denis ◽  
Yvan Petit ◽  
Francis Bernard ◽  
Dorothy Barthélemy ◽  
...  

IntroductionActivity-based therapy (ABT) is an important aspect of rehabilitation following traumatic spinal cord injury (SCI). Unfortunately, it has never been adapted to acute care despite compelling preclinical evidence showing that it is safe and effective for promoting neurological recovery when started within days after SCI. This article provides the protocol for a study that will determine the feasibility and explore potential benefits of early ABT in the form of in-bed leg cycling initiated within 48 hours after the end of spinal surgery for SCI.Methods and analysisPROMPT-SCI (protocol for rapid onset of mobilisation in patients with traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older with a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L2 undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30 min continuous sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours of the end of spinal surgery. The feasibility outcomes are: (1) absence of serious adverse events associated with cycling, (2) completion of 1 full session within 48 hours of spinal surgery for 90% of participants and (3) completion of 11 sessions for 80% of participants. Patient outcomes 6 weeks and 6 months after the injury will be measured using neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared with a matched historical cohort that has not undergone in-bed cycling using McNemar and Student’s t-tests for binary and continuous outcomes, respectively.Ethics and disseminationPROMPT-SCI is approved by the Research Ethics Board of the CIUSSS NIM. Recruitment began in April 2021. Dissemination strategies include publications in scientific journals and presentations at conferences.Trial registration numberNCT04699474.

2020 ◽  
Author(s):  
T Jogia ◽  
T Lübstorf ◽  
E Jacobson ◽  
E Scriven ◽  
S Atresh ◽  
...  

ABSTRACTBackgroundAcute traumatic spinal cord injury (SCI) induces a systemic immune response involving circulating white blood cells (WBC). How this response is influenced by overall trauma severity, the neurological level of injury and/or correlates with patient outcomes is poorly understood. The objective of this study was to identify relationships between early changes in circulating WBCs, injury characteristics, and long-term patient outcomes in individuals with traumatic SCI.MethodsWe retrospectively analysed data from n=161 SCI patients admitted to Brisbane’s Princess Alexandra Hospital (exploration cohort). Logistic regression models in conjunction with receiver-operator characteristic (ROC) analyses were used to assess the strength of specific links between the WBC response, respiratory infection incidence and neurological outcomes (American Spinal Injury Association Impairment Scale (AIS) grade conversion). An independent validation cohort from the Trauma Hospital Berlin, Germany (n=49) was then probed to assess the robustness of effects and to disentangle centre effects.ResultsWe find that the extent of acute neutrophilia in human SCI patients is positively correlated with New Injury Severity Scores (NISS) but inversely with the neurological outcome (AIS grade). Multivariate analysis demonstrated that acute SCI-induced neutrophilia is an independent predictor of AIS grade conversion failure, with an odds ratio (OR) of 4.16 and ROC area under curve (AUC) of 0.82 (p<0.0001). SCI-induced lymphopenia was separately identified as an independent predictor of better recovery (OR = 24.15; ROC AUC = 0.85, p<0.0001). Acute neutrophilia and increased neutrophil-lymphocyte ratios were otherwise significantly associated with respiratory infection presentation in both patient cohorts.ConclusionsOur findings demonstrate the prognostic value of modelling early circulating neutrophil and lymphocyte counts with patient characteristics for predicting the longer-term recovery after SCI.


2018 ◽  
Vol 1 (2) ◽  
pp. 34
Author(s):  
Mochamad Targib Alatas

Early surgical treatment for traumatic spinal cord injury (SCI) patients has been proven to yield better improvement on neurological state, and widely practiced among surgeons in this field. However, it is not always affordable in every clinical setting. It is undeniable that surgery for chronic SCI has more challenges as the malunion of vertebral bones might have initiated, thus requires more complex operating techniques. In this case series, we report 7 patients with traumatic SCI whose surgical intervention is delayed due to several reasons. Initial motoric scores vary from 0 to 3, all have their interval periods supervised between outpatient clinic visits. On follow up they demonstrate significant neurological development defined by at least 2 grades motoric score improvement. Physical rehabilitation also began before surgery was conducted. These results should encourage surgeons to keep striving for the patient’s best interest, even when the injury has taken place weeks or even months before surgery is feasible because clinical improvement for these patients is not impossible. 


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