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).

Australian arm of the International Spinal Cord Injury (Aus-InSCI) Community Survey: 2. Understanding the lived experience in people with spinal cord injury.

STUDY DESIGN: Cross-sectional survey. OBJECTIVES: To identify common problems across key domains of functioning, health and wellbeing, as well as evaluate self-reported quality of life (QoL) by people with SCI, examining differences by age, gender, injury characteristics and level of mobility. SETTING: Data from four state-wide SCI clinical services, one government insurance agency and three not-for-profit consumer organisations. METHODS: Participants were 18 years or over with SCI and at least 12 months post-injury, recruited between Mar'18 and Jan'19. The Aus-InSCI questionnaire comprised 193 questions, including socio-demographics, SCI characteristics, body functions and structures, activities and participation, environmental and personal factors, and appraisal of health and well-being. General linear model was used to examine differences in functioning and QoL. RESULTS: Participants (mean age 57 years, range 19-94 years) with tetraplegia and/or complete injuries had more health problems, activity/participation problems and environmental barriers. However, self-rated overall QoL did not differ for injury level or completeness. Participants with more recent injuries exhibited lower independence levels, more mental health problems and poorer satisfaction with self and their living conditions. Major activity/participation problems related to intimate relationships and accessing public transportation. Less than half of the working age population were engaged in paid work. The top two environmental barriers frequently related to accessing public places or homes and unfavourable climatic conditions. CONCLUSIONS: This large, comprehensive community survey draws a detailed picture of the lived experience of people with SCI in Australia, identifying priority needs, gaps in services and barriers to achieving a full and satisfying life.

A prospective cohort study investigating contributors to mild cognitive impairment in adults with spinal cord injury: study protocol.

BACKGROUND: Studies report rates of mild cognitive impairment (MCI) in spinal cord injury (SCI) range between 10 and 60%. This broad estimate of MCI in SCI is most likely a result of: (i) inconsistent operationalization of MCI; (ii) heterogeneity among individuals with SCI; (iii) failure to account for MCI subtypes, thereby adding to the heterogeneity of samples; and, (iv) poor control for traumatic brain injury (TBI) that obscures differentiation of MCI attributable to TBI versus other factors. There is a paucity of longitudinal studies following the course of MCI in SCI, and none that account for multiple predictors of MCI, including interactions among predictors. METHODS: An inception cohort longitudinal study will assess approximately 100 individuals aged 17-80 years with acute SCI, with measures taken at three timepoints (baseline, 3 months post-baseline, and 12 months post-injury). Data relevant to medical care received within the first 24-48 h of presentation to the emergency department will be analysed, as will measures of cognition, injury characteristics, medical history, personal factors, psychological status, psychosocial functioning, and quality of life. Latent class mixture modelling will determine trajectories for the primary outcome of interest, cognitive functioning and its subtypes, and secondary outcomes of interest such as depression. Multiple regression analyses will identify predictors of MCI and its subtypes. DISCUSSION: The prospective design will reveal change in cognitive functioning across time and unveil different outcome trajectories; thus addressing the lack of knowledge on trajectories of MCI and MCI subtypes in SCI. Through subtyping MCI, we hope to yield groups of cognitively impaired individuals with SCI that are potentially more homogenous and thereby stable and predictable. This is the first study to capture emergency department and acute care diagnostic evidence of mild TBI, which has been poorly controlled in previous studies. Our study will also be the first to distinguish the contribution of TBI from other factors to the development of MCI in individuals with SCI. TRIAL REGISTRATION: The study was prospectively registered with the Australian and New Zealand Clinical Trial Registry ( ACTRN12619001702101 ) on 3rd December 2019.

Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a randomised controlled trial.

STUDY DESIGN: Randomised double-blind factorial-design placebo-controlled trial. OBJECTIVE: Urinary tract infections (UTIs) are common in people with spinal cord injury (SCI). UTIs are increasingly difficult to treat due to emergence of multi-resistant organisms. Probiotics are efficacious in preventing UTIs in post-menopausal women. We aimed to determine whether probiotic therapy with Lactobacillus reuteri RC-14+Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG+Bifidobacterium BB-12 (LGG-BB12) are effective in preventing UTI in people with SCI. SETTING: Spinal units in New South Wales, Australia with their rural affiliations. METHODS: We recruited 207 eligible participants with SCI and stable neurogenic bladder management. They were randomised to one of four arms: RC14-GR1+LGG-BB12, RC14-GR1+placebo, LGG-BB12+ placebo or double placebos for 6 months. Randomisation was stratified by bladder management type and inpatient or outpatient status. The primary outcome was time to occurrence of symptomatic UTI. RESULTS: Analysis was based on intention to treat. Participants randomised to RC14-GR1 had a similar risk of UTI as those not on RC14-GR1 (HR 0.67; 95% CI: 0.39-1.18; P = 0.17) after allowing for pre-specified covariates. Participants randomised to LGG-BB12 also had a similar risk of UTI as those not on LGG-BB12 (HR 1.29; 95% CI: 0.74-2.25; P = 0.37). Multivariable post hoc survival analysis for RC14-GR1 only vs. the other three groups showed a potential protective effect (HR 0.46; 95% CI: 0.21-0.99; P = 0.03), but this result would need to be confirmed before clinical application. CONCLUSION: In this RCT, there was no effect of RC14-GR1 or LGG-BB12 in preventing UTI in people with SCI.

Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial.

BACKGROUND: Urinary tract infections [UTIs] are very common in people with Spinal Cord Injury [SCI]. UTIs are increasingly difficult and expensive to treat as the organisms that cause them become more antibiotic resistant. Among the SCI population, there is a high rate of multi-resistant organism [MRO] colonisation. Non-antibiotic prevention strategies are needed to prevent UTI without increasing resistance. Probiotics have been reported to be beneficial in preventing UTIs in post-menopausal women in several in vivo and in vitro studies. The main aim of this study is to determine whether probiotic therapy with combinations of Lactobacillus reuteri RC-14 + Lactobacillus rhamnosus GR-1 [RC14-GR1] and/or Lactobacillus rhamnosus GG + Bifidobacterium BB-12 [LGG-BB12] are effective in preventing UTI in people with SCI compared to placebo. METHOD: This is a multi-site randomised double-blind double-dummy placebo-controlled factorial design study conducted in New South Wales, Australia. All participants have a neurogenic bladder as a result of spinal injury. Recruitment started in April 2011. Participants are randomised to one of four arms, designed for factorial analysis of LGG-BB12 and/or RC14-GR1 v Placebo. This involves 24 weeks of daily oral treatment with RC14-GR1 + LGG-BB12, RC14-GR1 + placebo, LGG-BB12 + placebo or two placebo capsules. Randomisation is stratified by bladder management type and inpatient status. Participants are assessed at baseline, three months and six months for Short Form Health Survey [SF-36], microbiological swabs of rectum, nose and groin; urine culture and urinary catheters for subjects with indwelling catheters. A bowel questionnaire is administered at baseline and three months to assess effect of probiotics on bowel function. The primary outcome is time from randomisation to occurrence of symptomatic UTI. The secondary outcomes are change of MRO status and bowel function, quality of life and cost-effectiveness of probiotics in persons with SCI. The primary outcome will be analysed using survival analysis of factorial groups, with Cox regression modelling to test the effect of each treatment while allowing for the other, assuming no interaction effect. Hazard ratios and Kaplan-Meier survival curves will be used to summarise results. DISCUSSION: If these probiotics are shown to be effective in preventing UTI and MRO colonisation, they would be a very attractive alternative for UTI prophylaxis and for combating the increasing rate of antibiotic resistance after SCI. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry [ ACTRN 12610000512022 ]. Date of registration: 21 June 2010.

Integrated oral care for patients with spinal cord injuries: perceptions of non-dental professionals.

PURPOSE: To understand the oral health attitudes, knowledge, and practices among non-dental professionals caring for patients with spinal cord injuries, as well as the barriers and facilitators to oral care across acute and rehabilitation hospital settings. MATERIALS AND METHODS: This study was a descriptive qualitative study. Nine focus groups with spinal cord injury clinicians from two Sydney hospitals were conducted (n = 35). A thematic analysis was undertaken. RESULTS: Four themes were constructed: understanding the impact of spinal cord injuries on oral health and wellbeing; limited support in the spinal cord injury unit to promote oral care; strategies that enable oral care promotion; and recommendations to expand scope in oral care and education. Although most clinicians considered oral health to be important there was a lack of guidelines to support standardised oral care practices. Barriers included lack of time, limited oral care resources, low priority and difficulty in accessing treatment. Staff were receptive to an integrated, multidisciplinary approach to oral care. CONCLUSION: This Australian first study provides insight into spinal cord injury clinicians' knowledge and practices of oral care. The findings will help guide future research in developing appropriate models of care to promote oral health among patients with spinal cord injuries.

Individuals with a spinal cord injury are at an increased risk of irregular oral hygiene practices and poor oral health compared to those without a spinal cord injuryProviding access to training and development of a model of care for oral health promotion to support non-dental health professionals working with individuals with a spinal cord injury can improve access to early intervention oral health careImplementing targeted training for staff, developing clear guidelines or protocols, and piloting an integrated multidisciplinary model of care could be potential future solutions to close this gap in care.

Cognitive Impairment in Individuals With Spinal Cord Injury: Findings of a Systematic Review With Robust Variance and Network Meta-analyses.

BACKGROUND AND OBJECTIVES: Estimates of the prevalence (10-60%) of cognitive impairment in individuals with spinal cord injury (SCI) are too broad and which domains of cognition are most affected is unclear. We performed a meta-analysis to investigate impairments across domains of cognitive functioning to provide a nuanced picture of research conducted to date into cognitive impairment following SCI. METHODS: Results of peer reviewed studies published in English between 1980 and 2021 comparing ≥20 participants with SCI to able-bodied controls were synthesized using meta-analysis. The primary outcomes were neurocognitive test scores categorized into five cognitive domains as listed in the Diagnostic and Statistical Manual of Mental Disorders: Complex Attention, Executive Functioning, Learning and Memory, Language, and Perceptual Motor Function. Two researchers independently assessed and verified extracted data to comply with meta-analytic reporting guidelines. Robust variance estimation (RVE) meta-analysis was conducted to determine an overall pooled effect size across all cognitive domains using data extracted from studies. Using network meta-analysis, we synthesised eligible studies and made comparisons with the five domains of cognitive functioning serving as the outcomes and SCI as the condition. RESULTS: Of 4,783 potential studies, 13 met final inclusion criteria. Studies met 6 of 8 quality assessment criteria generally. Results suggested that adults with SCI have reduced cognitive functioning (effect size:-0.84; 95%CI: -1.24, -0.44, p < .001) compared to able-bodied individuals, with deficits mostly in attention (g= -0.64; 95%CI: -0.92, -0.38) and executive functioning (g= -0.61, 95%CI: -0.89, -0.04). Publication bias and high heterogeneity (I2:86%) qualify these findings and highlight the need to improve research methods in this area. DISCUSSION: Adults with SCI appear more likely than adults who are able-bodied to display cognitive impairments mostly in areas of attention and executive functioning. Research practices must become consistent to reduce heterogeneity so that the validity and reliability of the results of future studies into cognitive impairment following SCI improves.

The Need for a Specialized Neurocognitive Screen and Consistent Cognitive Impairment Criteria in Spinal Cord Injury: Analysis of the Suitability of the Neuropsychiatry Unit Cognitive Assessment Tool.

The assessment of mild cognitive impairment (MCI) following spinal cord injury (SCI) is vital. However, there are no neurocognitive screens which have been developed specifically to meet the unique requirements for SCI, nor are there consistent MCI criteria applied to determine the rates of MCI. The aim of this study was to determine the suitability of a neurocognitive screen for assessing MCI in adults with SCI. A total of 127 participants were recruited. Socio-demographic and injury related variables were assessed. All participants completed the screen. Descriptive statistics are provided for total/domain screen scores and all items, and the screen's ability to distinguish MCI was examined. Congeneric confirmatory factor analyses (CFA) were employed to investigate structural validity. The screen total score was sensitive to differences in neurocognitive capacity, as well as for time since the injury occurred (p < 0.01). The MCI rate ranged between 17−36%. CFA revealed attention and visuoconstruction domains had an adequate model fit and executive function had poor fit, while CFA models for memory and language did not fit the data (did not converge), hence could not be determined. While the screen differentiated between those with MCI and those without, and MCI as a function of time since injury, limitations of its suitability for assessing MCI after SCI exist, demonstrating the need for a specialized neurocognitive screen for adults with SCI.