Early and intensive Motor Training for people with spinal cord injuries (the SCI-MT Trial): description of the intervention.

STUDY DESIGN: Descriptive. OBJECTIVES: The primary objective is to describe the intervention that will be provided in a large multi-centre randomised controlled trial titled: Early and Intensive Motor Training for people with Spinal Cord Injuries (the SCI-MT Trial). The secondary objective is to describe the strategies that will be used to operationalise and standardise the Motor Training provided to participants while keeping the intervention person-centred. METHODS: The paper focuses on the rationale and principles of Motor Training for people with spinal cord injuries (SCI). The description of the intervention is based on the Template for Intervention Description and Replication (TIDieR) checklist. Specifically, it addresses the following 6 criteria of the TIDieR checklist: why the effectiveness of Motor Training is being examined; what, how, where and when the Motor Training will be administered; and how much Motor Training will be provided. RESULTS: A detailed intervention manual has been developed to help standardise the delivery of the intervention. CONCLUSIONS: This paper describes the details of a complex intervention administered as part of a large randomised controlled trial. It will facilitate the subsequent interpretation of the trial results and enable the intervention to be reproduced in clinical practice and future trials.

Author Correction: Is body-weight supported treadmill training or robotic-assisted gait training superior to overground gait training and other forms of physiotherapy in people with spinal cord injury? A systematic review.

The original article can be found online at https://doi.org/10.1038/sc.2017.31 .

A pilot randomised trial of community-based care following discharge from hospital with a recent spinal cord injury in Bangladesh.

OBJECTIVES: To explore the feasibility of conducting a full trial designed to determine the effectiveness of a model of community-based care for people with spinal cord injury in Bangladesh. STUDY DESIGN: A pilot randomised trial. SETTING: Community, Bangladesh. SUBJECTS: Participants were 30 people with recent spinal cord injury who were wheelchair-dependent and soon to be discharged from hospital. INTERVENTION: Participants randomised to the intervention group received a package of care involving regular telephone contact and three home visits over two years. Participants randomised to the control group received usual care consisting of a telephone call and an optional home visit. MAIN MEASURES: Participants were assessed at baseline and two years after randomization. The primary outcome was mortality and secondary outcomes were measures of complications, depression, participation and quality of life. RESULTS: A total of 24 participants had a complete spinal cord injury and six participants had an incomplete spinal cord injury. Median (interquartile) age and time since injury at baseline were 31 years (24 to 36) and 7 months (4 to 13), respectively. Two participants, one in each group, died. Five participants had pressure ulcers at two years. There were no notable impediments to the conduct of the trial and no significant protocol violations. The phone calls and home visits were delivered according to the protocol 87% and 100% of the time, respectively. Follow-up data were 99% complete. CONCLUSION: This pilot trial demonstrates the feasibility of a full clinical trial of 410 participants, which has recently commenced. SPONSORSHIP: University of Sydney, Australia.

Is body-weight-supported treadmill training or robotic-assisted gait training superior to overground gait training and other forms of physiotherapy in people with spinal cord injury? A systematic review.

STUDY DESIGN: Systematic review about randomised trials comparing different training strategies to improve gait in people with spinal cord injuries (SCI). OBJECTIVES: The aim of this systematic review was to compare the effectiveness of body-weight-supported treadmill training (BWSTT) and robotic-assisted gait training with overground gait training and other forms of physiotherapy in people with traumatic SCI. SETTING: Systematic review conducted by researchers from Germany and Australia. METHODS: An extensive search was conducted for randomised controlled trials involving people with traumatic SCI that compared either BWSTT or robotic-assisted gait training with overground gait training and other forms of physiotherapy. The two outcomes of interest were walking speed (m s-1) and walking distance (m). BWSTT and robotic-assisted gait training were analysed separately, and data were pooled across trials to derive mean between-group differences using a random-effects model. RESULTS: Thirteen randomised controlled trials involving 586 people were identified. Ten trials involving 462 participants compared BWSTT to overground gait training and other forms of physiotherapy, but only nine trials provided useable data. The pooled mean (95% confidence interval (CI)) between-group differences for walking speed and walking distance were -0.03 m s-1 (-0.10 to 0.04) and -7 m (-45 to 31), respectively, favouring overground gait training. Five trials involving 344 participants compared robotic-assisted gait training to overground gait training and other forms of physiotherapy but only three provided useable data. The pooled mean (95% CI) between-group differences for walking speed and walking distance were -0.04 m s-1 (95% CI -0.21 to 0.13) and -6 m (95% CI -86 to 74), respectively, favouring overground gait training. CONCLUSIONS: BWSTT and robotic-assisted gait training do not increase walking speed more than overground gait training and other forms of physiotherapy do, but their effects on walking distance are not clear.

The reliability of measuring wound undermining in people with spinal cord injury.

OBJECTIVE: The objective of this study was to determine the reliability of measuring wound undermining in people with spinal cord injury (SCI). STUDY DESIGN: A psychometric study. SETTING: The study was conducted at the Indian Spinal Injuries Centre, New Delhi, India. PARTICIPANTS: Thirty people with a complete or incomplete SCI and a pressure ulcer with wound undermining were recruited. METHODS: Wound undermining was measured using the four cardinal points from a clock face (with 12 O'clock defined as towards the head). Inter-rater reliability was tested by comparing the wound undermining scores from two different assessors. Intra-rater reliability was tested by comparing the wound undermining scores from the same assessor on two different days. RESULTS: The intraclass correlation coefficients (95% confidence interval) for inter-rater and intra-rater reliability were 0.996 (0.992-0.999) and 0.998 (0.996-0.999), respectively. Repeat measurements by the same and different assessor were within 0.3 cm of each other, 80% and 83% of the time, respectively. CONCLUSION: Measurements of wound undermining have excellent reliability.

Achieving assessor accuracy on the International Standards for Neurological Classification of Spinal Cord Injury.

STUDY DESIGN: A retrospective audit of assessor accuracy using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) in three multicentre randomised controlled trials (SCIPA: Spinal Cord Injury and Physical Activity) spanning 2010-2014 with standards revised in 2011. OBJECTIVES: To investigate assessor accuracy of neurological classification after spinal cord injury. SETTING: Australia and New Zealand. METHODS: ISNCSCI examinations were undertaken by trained clinicians prior to randomisation. Data were recorded manually and ISNCSCI worksheets circulated to panels, consensus reached and worksheets corrected. An audit team used a 2014 computerised ISNCSCI algorithm to check manual worksheets. A second audit team assessed whether the 2014 computerised algorithm accurately reflected pre- and post-2011 ISNCSCI standards. RESULTS: Of the 208 ISNCSCI worksheets, 24 were excluded. Of the remaining 184 worksheets, 47 (25.5%) were consistent with the 2014 computerised algorithm and 137 (74.5%) contained one or more errors. Errors were in motor (30.1%) or sensory (12.4%) levels, zone of partial preservation (24.0%), motor/sensory scoring (21.5%), ASIA Impairment Scale (AIS, 8.3%) and complete/incomplete classification (0.8%). Other difficulties included classification when anal contraction/sensation was omitted, incorrect neurological levels and violation of the 'motor follows sensory rule in non-testable myotomes' (7.4%). Panel errors comprised corrections that were incorrect or missed or incorrect changes to correct worksheets. CONCLUSION: Given inaccuracies in the manual ISNCSCI worksheets in this long-term clinical trial setting, continued training and a computerised algorithm are essential to ensure accurate scoring, scaling and classification of the ISNCSCI and confidence in clinical trials.

Telephone-based management of pressure ulcers in people with spinal cord injury in low- and middle-income countries: a randomised controlled trial.

STUDY DESIGN: A multicentre, prospective, assessor-blinded, parallel randomised controlled trial. OBJECTIVES: The objective of the trial was to determine the effectiveness of telephone-based management of pressure ulcers in people with spinal cord injury (SCI) in low- and middle-income countries. METHODS: One hundred and twenty people with SCI living in the community were recruited through three hospitals in India and Bangladesh between November 2013 and March 2016. Participants had sustained an SCI >3 months prior and had a pressure ulcer. Participants were randomly allocated (1:1) to a control or intervention group. Participants in the control group received no intervention. Participants in the intervention group received weekly advice by telephone for 12 weeks about the management of their pressure ulcers from a trained health-care professional. Outcomes were measured by a blinded assessor at baseline and 12 weeks. There was one primary outcome, namely, the size of the pressure ulcer and 13 secondary outcomes. RESULTS: The mean between-group difference for the size of the pressure ulcer at 12 weeks was 2.3 cm2 (95% confidence interval -0.3 to 4.9; favouring the intervention group). Eight of the 13 secondary outcomes were statistically significant. CONCLUSION: The results of our primary outcome (that is, size of pressure ulcer) do not provide conclusive evidence that people with SCI can be supported at home to manage their pressure ulcers through regular telephone-based advice. However, the results from the secondary outcomes are sufficiently positive to provide hope that this simple intervention may provide some relief from this insidious problem in the future.

Cost-effectiveness analysis of telephone-based support for the management of pressure ulcers in people with spinal cord injury in India and Bangladesh.

OBJECTIVE: To determine from a societal perspective the cost-effectiveness and cost-utility of telephone-based support for management of pressure ulcers. STUDY DESIGN: Cost-effectiveness and cost-utility analysis of a randomised clinical trial. SETTING: Tertiary centre in India and Bangladesh. METHODS: An economic evaluation was conducted alongside a randomised clinical trial comparing 12 weeks of telephone-based support (intervention group) with usual care (control group). The analyses evaluated costs and health outcomes in terms of cm2 reduction of pressure ulcers size and quality-adjusted life years (QALYs) gained. All costs were in Indian Rupees (INR) and then converted to US dollars (USD). RESULTS: The mean (95% confidence interval) between-group difference for the reduction in size of pressure ulcers was 0.53 (-3.12 to 4.32) cm2, favouring the intervention group. The corresponding QALYs were 0.027 (0.004-0.051), favouring the intervention group. The mean total cost per participant in the intervention group was INR 43 781 (USD 2460) compared to INR 42 561 (USD 2391) for the control group. The per participant cost of delivering the intervention was INR 2110 (USD 119). The incremental cost-effectiveness ratio was INR 2306 (USD 130) per additional cm2 reduction in the size of the pressure ulcer and INR 44 915 (USD 2523) per QALY gained. CONCLUSION: In terms of QALYs, telephone-based support to help people manage pressure ulcers at home provides good value for money and has an 87% probability of being cost-effective, based on 3 times gross domestic product. Sensitivity analyses were performed using the overall cost data with and without productivity costs, and did not alter this conclusion.

Strength training for partially paralysed muscles in people with recent spinal cord injury: a within-participant randomised controlled trial.

STUDY DESIGN: Within-participant randomised controlled trial. OBJECTIVES: To determine whether strength training combined with usual care increases strength in partially paralysed muscles of people with recent spinal cord injury (SCI) more than usual care alone. SETTINGS: SCI units in Australia and India. METHODS: Thirty people with recent SCI undergoing inpatient rehabilitation participated in this 12-week trial. One of the following muscle groups was selected as the target muscle group for each participant: the elbow flexors, elbow extensors, knee flexors or knee extensors. The target muscle on one side of the body was randomly allocated to the experimental group and the same muscle on the other side of the body was allocated to the control group. Strength training was administered to the experimental muscle but not to the control muscle. Participants were assessed at baseline and 12 weeks later. The primary outcome was maximal isometric muscle strength, and the secondary outcomes were spasticity, fatigue and participants' perception of function and strength. RESULTS: There were no dropouts, and participants received 98% of the training sessions. The mean (95% confidence interval (CI)) between-group difference for isometric strength was 4.3 Nm (1.9-6.8) with a clinically meaningful treatment effect of 2.7 Nm. The mean (95% CI) between-group difference for spasticity was 0.03/5 points (-0.25 to 0.32). CONCLUSION: Strength training increases strength in partially paralysed muscles of people with recent SCI, although it is not clear whether the size of the treatment effect is clinically meaningful. Strength training has no deleterious effects on spasticity.

Biological responses of Raw 264.7 macrophage exposed to two strains of Stachybotrys chartarum spores grown on four different wallboard types.

The many benefits of building "green" have motivated the use of sustainable products in the design and execution of the built environment. However, the use of these natural or recycled materials, some of which have been treated with antimicrobials, provides a growth opportunity for microorganisms with the potential to elicit adverse health effects especially in the presence of an antimicrobial. The focus of this research was to determine the effects of Stachybotrys chartarum (strains Houston and 51-11) grown under different conditions on a macrophage cell line (Raw 264.7) using endpoints, including cytotoxicity, and those associated with immunity specifically inflammation and MHC class II expression. The fungi were grown on four different gypsum products, and macrophages were exposed to whole spores of both strains and fragmented spores of strain 51-11. Whole spores of the Houston strain elicited no cytotoxicity with some level of inflammation, while exposure to whole spores of 51-11 caused variable responses depending on the wallboard type supporting the fungal growth. High concentrations of fragmented 51-11 spores primarily resulted in the apoptosis of macrophage with no inflammation. None of the fungal strains caused elevated levels of major histocompatibility complex (MHC) class II expression on the surface of Raw cells. Mycotoxin levels of 51-11 spores from all of the wallboard types measured >250 ng/µL of T2 equivalent toxin based on activity. Collectively, the data demonstrated that all of the wallboard types supported growth of fungi with the ability to elicit harmful biological responses with the potential to negatively impact human health.

The effectiveness of 22 commonly administered physiotherapy interventions for people with spinal cord injury: a systematic review.

STUDY DESIGN: A systematic review of randomised controlled trials. OBJECTIVES: To determine the effectiveness of 22 commonly administered physiotherapy interventions for people with spinal cord injuries (SCIs). METHODS: The inclusion criteria contained 22 pairs of key interventions and outcomes. Each intervention and outcome was considered independently such that 22 brief reviews were conducted and summarised in this one paper. The interventions included hand, wheelchair, seated mobility, fitness, strength and gait training, as well as electrical stimulation, passive movements, stretch, cycling, exercise and transcutaneous electrical nerve stimulation (TENS). Interventions were compared with no or sham treatment, usual care or another physiotherapy intervention. The primary outcome for each review was one of the following: seated mobility, wheelchair mobility, hand function, gait, voluntary strength, joint mobility, fitness and pain. Data were extracted to determine mean between-group differences or risk ratios (95% confidence interval). Where possible, results were pooled in meta-analyses and the strength of evidence rated using Grading of Recommendations Assessment, Development and Evaluation. RESULTS: Thirty-eight randomised controlled trials met the inclusion criteria and were relevant to 15 of the brief reviews. The following four interventions were clearly effective: fitness, hand and wheelchair training as well as TENS; however, the strength of evidence was not high for any of these interventions. None of the other interventions were clearly effective. CONCLUSION: There is initial evidence to support four physiotherapy interventions, but there is still a long way to go to put a strong evidence base to the range of physiotherapy interventions commonly used to manage people with SCI.

Psychological and socioeconomic status, complications and quality of life in people with spinal cord injuries after discharge from hospital in Bangladesh: a cohort study.

STUDY DESIGN: Mixed retrospective-prospective cohort study. OBJECTIVES: To determine psychological and socioeconomic status, complications and quality of life in people with spinal cord injuries (SCI) after discharge from a hospital in Bangladesh. SETTING: Bangladesh. METHODS: All patients admitted in 2011 with a recent SCI to a hospital in Bangladesh were identified. Patients were interviewed by telephone in 2014 using translated versions of the SF12, the SCI Secondary Conditions Scale, the Centre for Epidemiologic Studies Depression Scale (CESDS) and the Participation Component of the WHODAS. Questions were also asked about employment, living and financial situation, and opportunities to get out of bed and out of the house. Data were stratified by ability to walk on discharge. RESULTS: A total of 350 people were discharged with a recent SCI in 2011. By 2014, 55 had died. Of those still living, 283 were interviewed (96% follow-up rate). At the time of interview, 47% of participants were employed. One-quarter (26%) of those who were wheelchair-dependent had a pressure ulcer. The mean (s.d.) scores for the Mental and Physical Component of the SF12 were 32.0 points (5.5) and 35.8 points (3.9), respectively. The median (interquartile range) scores for the SCI Secondary Conditions Scale, CESDS and WHODAS for those who were wheelchair-dependent were 15% (10 to 19), 11 points (9 to 18) and 26 points (23 to 26), respectively. CONCLUSION: Many people with SCI in Bangladesh are house-bound, unemployed, living in poverty and have pressure ulcers. They experience moderate rates of depression and report limited quality of life.

Two-year survival following discharge from hospital after spinal cord injury in Bangladesh.

STUDY DESIGN: Mixed retrospective-prospective cohort study. OBJECTIVES: To determine 2-year survival following discharge from hospital after spinal cord injury in Bangladesh. SETTING: Bangladesh. METHODS: Medical records were used to identify all patients admitted in 2011 with a recent spinal cord injury to the Centre for Rehabilitation of the Paralysed, a large Bangladeshi hospital that specialises in care of people with spinal cord injury. Patients or their families were subsequently visited or contacted by telephone in 2014. Vital status and, where relevant, date and cause of death were determined by verbal autopsy. RESULTS: 350 of 371 people admitted with a recent spinal cord injury in 2011 were discharged alive from hospital. All but eleven were accounted for two years after discharge (97% follow-up). Two-year survival was 87% (95% CI 83% to 90%). Two-year survival of those who were wheelchair-dependent was 81% (95% CI 76% to 86%). The most common cause of death was sepsis due to pressure ulcers. CONCLUSION: In Bangladesh, approximately one in five people with spinal cord injury who are wheelchair-dependent die within two years of discharge from hospital. Most deaths are due to sepsis from potentially preventable pressure ulcers.

Reliability of the International Spinal Cord Injury Musculoskeletal Basic Data Set.

STUDY DESIGN: Psychometric study. OBJECTIVES: To determine the intra- and inter-rater reliability and content validity of the International Spinal Cord Injury (SCI) Musculoskeletal Basic Data Set (ISCIMSBDS). SETTING: Four centers with one in each of the countries in Australia, England, India and the United States of America. METHODS: A total of 117 participants with a C2 to S1 neurological level and American Spinal Injury Association Impairment Scale A to D injury were recruited. The median (interquartile range) time since injury was 9 years (2-29). Fifty-seven participants were assessed by the same assessor, and 60 participants were assessed by two different assessors on two different occasions to determine the intra- and inter-rater reliability, respectively. Kappa statistics or crude agreement was used to measure reliability. Content validity was assessed through focus group interviews of people with SCI and health-care professionals. RESULTS: The intra-rater reliability ranged from κ=0.62 to 1.00 and crude agreement from 75% to 100% for each of the variables on the ISCIMSBDS. The inter-rater reliability ranged from κ=-0.25 to 1.00, with a diverse crude agreement ranging from 0% to 100%. The inter-rater reliability was unsatisfactory for the following variables: 'Date of fracture', 'Fragility fractures', 'Scoliosis, method of assessment', 'Other musculoskeletal problems' and 'Do any of the above musculoskeletal challenges interfere with your activities of daily living (transfers, walking, dressing, showers, etc.)?'. Results from validity discussions implied no major suggestions for changes. CONCLUSION: Overall, the ISCIMSBDS is reliable and valid, although 5 of the 12 variables may benefit from further refinement.

A telephone-based version of the spinal cord injury-secondary conditions scale: a reliability and validity study.

OBJECTIVE: The objective of this study was to determine the inter-rater reliability and validity of using a telephone-based version of the spinal cord injury-secondary conditions scale (SCI-SCS). TRIAL DESIGN: A psychometric study was conducted. SETTING: The study was conducted in Royal North Shore Hospital, Sydney, Australia. PARTICIPANTS: Forty people with a complete or an incomplete spinal cord injury. METHODS: Inter-rater reliability was tested by comparing the telephone-based version of the SCI-SCS administered on two different days by two different telephone assessors. Validity was tested by comparing the telephone-based version of the SCI-SCS with the paper-based version of the SCI-SCS. RESULTS: The median (interquartile range) age and time since injury were 54 (48-63) years and 28 (14-35) years, respectively. The intraclass correlation coefficient (95% confidence interval) reflecting the agreement between the telephone-based version of the SCI-SCS administered on two different days by two different assessors was 0.96 (0.93-0.98). The corresponding value reflecting agreement between the telephone-based assessment and the paper-based assessment was 0.90 (0.83-0.95). CONCLUSION: The telephone-based version of the SCI-SCS is a simple and a quick questionnaire to administer that has both inter-rater reliability and validity. It may be useful as a way to screen for secondary health conditions in low- and middle-income countries where it is not always feasible to provide routine face-to-face follow-ups and where literacy may be a problem.

Development, reliability and validity of the queensland evaluation of wheelchair skills (QEWS).

STUDY DESIGN: Psychometric studyObjectives:To develop and test a valid and reliable assessment of wheelchair skills for individuals with spinal cord injuries (SCI); the Queensland Evaluation of Wheelchair Skills (QEWS). SETTING: Hospital, Australia. METHODS: Phase 1: Four Delphi panel rounds with clinical experts were used to develop the QEWS. Phase 2: Intra-rater and inter-rater reliability of the QEWS items were examined in 100 people with SCI. Phase 3a: Concurrent validity was investigated by examining the association between QEWS total scores and physiotherapists' global ratings of wheelchair skill performance. Phase 3b: Construct validity was tested in 20 people with recent SCI by examining change in QEWS total scores between when they first mobilised in a wheelchair and scores obtained 10 weeks later. RESULTS: Phase 1: The QEWS was developed. Phase 2: The intra-class correlation coefficients reflecting the intra-rater reliability and the inter-rater reliability for the QEWS total score were 1.00 and 0.98, with scores being within one point of each other 96 and 91% of the time, respectively. Phase 3a: The QEWS total scores were comparable with the global rating of wheelchair skill performance (r2=0.93). Phase 3b: The QEWS scores changed by a median (interquartile range (IQR)) of 4 (1 to 6) points over the 10-week period following first wheelchair mobilisation. CONCLUSION: The QEWS is a valid and reliable tool for measuring wheelchair skills in individuals with SCI. The QEWS is efficient and practical to administer and does not require specialised equipment.

The effect of arm position and bed adjustment on comfort and pressure under the shoulders in people with tetraplegia: a randomized cross-over study.

STUDY DESIGN: Randomized, within-in participant cross-over study. OBJECTIVE: The purpose of this study was to determine the effect on comfort and pressure of lying with the shoulders and bed in different positions for people with tetraplegia. SETTING: Rehabilitation hospital. METHODS: Twenty people with tetraplegia were tested lying supine with the shoulders and bed in seven different positions. The positions used a combination of three arm and two bed positions. Six of the positions reflected what is commonly recommended in acute spinal cord injury units including a crucifix-type position. The seventh position was selected by participants and reflected their preferred sleeping position. There were five outcomes: general comfort, shoulder comfort, participant choice of preferred position, peak pressure under the shoulders and areal pressure under the shoulders. Pressure was measured using a pressure mapping system and comfort using a visual analogue scale (VAS). RESULTS: The participants reported significantly higher (P<0.01) general comfort and shoulder comfort in their self-selected position compared with all other positions. There was no statistical difference in peak pressure (P=0.15) or areal pressure (P=0.08) under the shoulders between the seven positions. Most participants indicated that they preferred to lie with their shoulders adducted and internally rotated and the hands either by their sides or on their stomachs. CONCLUSION: The position of the shoulders has little effect on pressure but a notable effect on comfort. Participants preferred to sleep with their arms beside their bodies, not with their arms in a crucifix position as commonly advocated.