A therapist-administered self-report version of the Walking Index for Spinal Cord Injury II (WISCI): a psychometric study.

OBJECTIVE: To develop a self-report version of the Walking Index for Spinal Cord Injury II (WISCI II) and to test its reliability and validity. STUDY DESIGN: Psychometric study. SETTING: Spinal cord injury (SCI) rehabilitation centres in Australia and Italy. PARTICIPANTS: Eighty people with SCI were recruited from a sample of convenience. METHODS: Two self-report versions of the WISCI II were developed. Both versions were administered in English at the Australian site, and in Italian at the Italian site through an online platform. The format of the first self-report version (SR-V1) was similar to the original face-to-face WISCI II. The second self-report version (SR-V2) had more questions, but each question required participants to focus on one aspect of walking at a time. Participants completed SR-V1 and SR-V2 with assistance from research physiotherapists on two separate occasions, three to seven days apart. The original WISCI II was then administered through a face-to-face assessment by an independent physiotherapist. The intra-rater reliability and validity of SR-V1 and SR-V2 were determined with intraclass correlation coefficients (ICC) and percent close agreements. RESULTS: The data from the Australian and Italian sites were pooled. The validity and reliability of the two self-report versions were very similar, with SR-V2 performing slightly better than SR-V1. The ICC (95% confidence interval) of SR-V2 was 0.87 (0.81-0.92). The ICC reflecting the agreement between the self-report and the face-to-face WISCI was 0.89 (0.84-0.93). CONCLUSION: Both versions of the self-report WISCI II provide a reasonable substitute for a face-to-face assessment although therapists preferred SR-V2.

Using the benefit-harm trade-off method to determine the smallest worthwhile effect of intensive motor training on strength for people with spinal cord injury.

STUDY DESIGN: Interviews using the benefit-harm trade-off method and an online survey. OBJECTIVES: To determine the smallest worthwhile effect (SWE) of motor training on strength for people with spinal cord injury (SCI). SETTING: SCI units, Australia. METHODS: Forty people with recent SCI who had participated in motor training as part of their rehabilitation program (patient participants) and 37 physiotherapists (physiotherapist participants) working in SCI were recruited. The patient participants underwent an iterative process using the benefit-harm trade-off method to determine the SWE of motor training on strength. The physiotherapist participants were given an online survey to determine the SWE for five different scenarios. Both groups considered the SWE of a physiotherapy intervention involving an additional 12 h of motor training for 10 weeks on top of usual care. They were required to estimate the smallest improvement in strength (points on the Total Motor Score of the International Standards for Neurological Classification of SCI) to justify the effort and associated costs, risks or inconveniences of the motor training. RESULTS: The median (interquartile range) smallest improvement in strength that patient and physiotherapist participants deemed worth the effort and associated costs, risks or inconveniences of the motor training was 3 (1-5) points, and 9 (7-13) points, respectively. CONCLUSIONS: People with recent SCI are willing to devote 12 h a week for 10 weeks to motor training in addition to their usual care to gain small changes in strength. Physiotherapists wanted to see greater improvements to justify the intervention.

A case report of three people experiencing intractable autonomic dysreflexia following instillation of Uro-Tainer® Polyhexanide 0.02.

INTRODUCTION: Historically, bladder washouts were used to instil therapeutic reagents directly into the bladder. This practice has expanded to include instillation of solutions that deal with catheter issues such as encrustation or formation of bio-film. They appear to provide a promising strategy for people with long term catheters. These products are readily available to purchase, but there is concern that people are using these solutions without a complete understanding of the purpose for the rinse and without clinical guidance to monitor response to treatment. CASE PRESENTATION: These case studies include three people living with spinal cord injury (SCI) who developed severe autonomic dysreflexia (AD) when a catheter rinse was carried out using a particular solution. Each of the cases developed immediate and, in some cases, intractable AD requiring further intervention to resolve symptoms. DISCUSSION: Catheter-associated urinary tract infection is a significant cause of morbidity and mortality in people living with SCI. Long-term catheters provide a vector for opportunistic micro-organisms to form bio-film and create an environment that promotes formation of struvite calculi, thus increasing the risk of chronic catheter blockage and urinary tract infection. Whilst these solutions are used to reduce these risks, they also pose additional risks to people susceptible to AD. These cases highlight the need for judicious patient selection and clinical oversight and management of adverse events when using catheter rinse solutions in certain people living with SCI. This is supported by a decision-making algorithm and a response to AD algorithm. This case report was prepared following the CARE Guidelines (supplementary file 1).

Remotely delivered physiotherapy is as effective as face-to-face physiotherapy for musculoskeletal conditions (REFORM): a randomised trial.

QUESTION: Is remotely delivered physiotherapy as good or better than face-to-face physiotherapy for the management of musculoskeletal conditions? DESIGN: Randomised controlled, non-inferiority trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: A total of 210 adult participants with a musculoskeletal condition who presented for outpatient physiotherapy at five public hospitals in Sydney. INTERVENTION: One group received a remotely delivered physiotherapy program for 6 weeks that consisted of one face-to-face physiotherapy session in conjunction with weekly text messages, phone calls at 2 and 4 weeks, and an individualised home exercise program delivered through an app. The other group received usual face-to-face physiotherapy care in an outpatient setting. OUTCOME MEASURES: The primary outcome was the Patient Specific Functional Scale at 6 weeks with a pre-specified non-inferiority margin of -15 out of 100 points. Secondary outcomes included: the Patient Specific Functional Scale at 26 weeks; kinesiophobia, pain, function/disability, global impression of change and quality of life at 6 and 26 weeks; and satisfaction with service delivery at 6 weeks. RESULTS: The mean between-group difference (95% CI) for the Patient Specific Functional Scale at 6 weeks was 2.7 out of 100 points (-3.5 to 8.8), where a positive score favoured remotely delivered physiotherapy. The lower end of the 95% CI was greater than the non-inferiority margin. Whilst non-inferiority margins were not set for the secondary outcomes, the 95% CI of the mean between-group difference ruled out clinically meaningful differences. CONCLUSION: Remotely delivered physiotherapy with support via phone, text and an app is as good as face-to-face physiotherapy for the management of musculoskeletal conditions. TRIAL REGISTRATION: ACTRN12619000065190.

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).

The 2022 Massive Open Online Course (MOOC) to train physiotherapists in the management of people with spinal cord injuries: a qualitative and quantitative analysis of learners' experiences and its impact.

STUDY DESIGN: Observational. OBJECTIVES: To determine the learners' experience and the impact of a Massive Open Online Course (MOOC) conducted to teach physiotherapists about the management of people with spinal cord injuries (SCI). METHODS: A SCI MOOC for physiotherapists was run in 5 different languages at the end of 2022. Qualitative and quantitative data were collected from different sources including registration details, pre- and post-MOOC Knowledge Assessments, a post-MOOC Evaluation, social media posts and online tracking of websites and emails. The data were used to answer four key questions: (i) what was the reach of the MOOC, (ii) what did participants think about the MOOC (iii) did the MOOC change participants' knowledge and/or confidence, and (iv) did the MOOC change participants' clinical practice or the way they teach others? RESULTS: 25,737 people from 169 countries registered for the MOOC. 98% of participants who completed the Evaluation (n = 2281) rated the MOOC as either "good" or "very good". Participants' knowledge improved by a median (IQR) of 25% (10 to 45%) (n = 4016 participants) on the MOOC Knowledge Assessment. Participants reported changes in confidence, and intentions to change clinical practice and incorporate what they had learnt into the way they teach others in response to the MOOC. CONCLUSION: The MOOC provided an efficient way to increase physiotherapists' knowledge about the physiotherapy management of people with SCI. Participants enjoyed the MOOC, and indicated an intention to change clinical practice and the way they taught others.

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).

Implementing digital devices to increase mobility training for people receiving inpatient rehabilitation: protocol for a feasibility hybrid type II randomized controlled trial.

BACKGROUND: People with mobility limitations can benefit from rehabilitation programs incorporating intensive, repetitive, and task-specific exercises using digital devices such as virtual reality gaming systems, tablet and smartphone applications, and wearable devices. The Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial (n = 300) showed improvements in mobility in people using these types of digital devices in addition to their usual rehabilitation care when the intervention was provided by an additional study-funded physiotherapist. However, it is not clear if this intervention can be implemented by hospital physiotherapists with a usual clinical load. The AMOUNT Implementation trial aims to explore the feasibility of conducting a large-scale implementation trial. METHODS: A pragmatic, assessor blinded, feasibility hybrid type II randomized controlled trial will be undertaken at a public hospital in Australia. There will be two phases. Phase I (Implementation phase) will involve implementing the digital devices into physiotherapy practice. Physiotherapists from the rehabilitation ward will receive a multifaceted implementation strategy guided by the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model. The implementation strategy includes identifying and training a clinical champion; providing digital devices and education and training; facilitating use of the devices through clinical reasoning sessions and journal clubs; and audit and feedback of exercise dosage documentation. Phase II (Trial phase) will involve randomising 30 eligible inpatients from the same ward into either usual care or usual care plus an additional 30 min or more of exercises using digital devices. This intervention will be provided by the physiotherapists who took part in the implementation phase. We will collect data on feasibility, implementation, and patient-level clinical outcomes. The three primary outcome measures are the extent to which physiotherapists document the dosage of exercises provided to participants (feasibility criteria: exercise practice sheets complete for ≥85% of all participants); ability to recruit participants; and fidelity to the protocol of using digital devices to prescribe exercises (feasibility criteria: average of ≥ 30mins per day for > 50% intervention participants). DISCUSSION: This feasibility study will provide important information to guide the planning and conduct of a future large-scale implementation trial. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry; ACTRN12621000938808; registered 19/07/2021. Trial sponsor: Prince of Wales Hospital. 320-346 Barker Street, Randwick, NSW, 2031, Australia. PROTOCOL VERSION: 6.2 7th April 2021.

Developing spinal cord injury physiotherapy clinical practice guidelines: a qualitative study to determine how physiotherapists and people living with spinal cord injury use evidence.

STUDY DESIGN: Generic qualitative design. OBJECTIVES: Australian and New Zealand SCI physiotherapists are developing clinical practice guidelines for the physiotherapy management of people living with spinal cord injury. To guide the development of the guidelines it was important to understand how physiotherapists and people living with spinal cord injury use evidence to choose interventions and the potential barriers and facilitators to the uptake of the clinical practice guidelines. SETTING: Spinal Cord Injury Centres in Sydney, Australia and New Zealand. METHODS: Focus groups and interviews with physiotherapists and people living with spinal cord injury were recorded, transcribed, and subjected to thematic analysis. RESULTS: A total of 75 participants took part in the study, 45 physiotherapists and 30 people living with spinal cord injury. Three main themes were identified from the data: (1) Types and sources of evidence that influence treatment choices, (2) the many factors determining treatment choices, and (3) ways in which clinical practice guidelines could influence treatment. CONCLUSIONS: Clinical practice guidelines have the potential to reduce the barriers identified by physiotherapists in accessing and interpreting research evidence on interventions for people living with spinal cord injury. Supported implementation of guidelines is required to demonstrate their benefit and encourage physiotherapists to factor in evidence when balancing the multiple factors influencing choice of physiotherapy intervention.

Protocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial.

INTRODUCTION: The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. The trial is currently being conducted across Sydney government hospitals in Australia. This process evaluation will run alongside the REFORM trial. It combines qualitative and quantitative data to help explain the trial results and determine the feasibility of rolling out supported home exercise programmes in settings similar to the REFORM trial. METHODS AND ANALYSIS: Two theoretical frameworks underpin our process evaluation methodology: the Realist framework (context, mechanism, outcomes) considers the causal assumptions as to why a supported home exercise programme may be as good or better than face-to-face physiotherapy in terms of the context, mechanisms and outcomes of the trial. The RE-AIM framework describes the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention. These two frameworks will be broadly used to guide this process evaluation using a mixed-methods approach. For example, qualitative data will be derived from interviews with patients, healthcare professionals and stakeholders, and quantitative data will be collected to determine the cost and feasibility of providing supported home exercise programmes. These data will be analysed iteratively before the analysis of the trial results and will be triangulated with the results of the primary and secondary outcomes. ETHICS AND DISSEMINATION: This trial will be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2018) and the Note for Good Clinical Practice (CPMP/ICH-135/95). Ethical approval was obtained on 17 March 2017 from the Northern Sydney Local Health District Human Research Ethics Committee (trial number: HREC/16HAWKE/431-RESP/16/287) with an amendment for the process evaluation approved on 4 February 2020. The results of the process evaluation will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12619000065190.

Are micro enemas administered with a squeeze tube and a 5 cm-long nozzle as good or better than micro enemas administered with a 10 cm-long catheter attached to a syringe in people with a recent spinal cord injury? A non-inferiority, crossover randomised controlled trial.

STUDY DESIGN: Double blind, non-inferiority crossover randomised controlled trial. OBJECTIVES: To determine if micro enemas administered with a squeeze-tube and a 5 cm-long nozzle (squeeze-tube method) are as good or better than micro enemas administered with a 10 cm-long catheter attached to a syringe (catheter method) in people with a recent spinal cord injury. SETTING: Two inpatient spinal cord injury units located in Sydney, Australia. METHODS: Twenty people admitted to hospital with recent spinal cord injury were randomly assigned to two treatment sequences; 4 weeks of micro enemas delivered by the squeeze-tube method followed by 4 weeks of micro enemas delivered by the catheter method, or vice versa. Each treatment sequence was 8 weeks with a crossover at the end of week 4. The primary outcome was time to complete bowel care. Secondary outcomes reflected faecal incontinence, quality of life, perception of treatment effectiveness and participant reported time to complete bowel care. The primary and secondary outcomes were measured by blinded assessors in week 4 and week 8. A non-inferiority margin of 10 min for time to complete bowel care was set a priori. RESULTS: The mean between group difference (95% confidence interval) for the time to complete bowel care was -0.5 min (-2.8 to 1.8), where a negative value favours the catheter method. Results were similar for all secondary outcomes. CONCLUSIONS: Micro enemas delivered by the squeeze-tube method are as good or better than micro enemas delivered by the catheter method in people with a recent spinal cord injury.

Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial.

BACKGROUND: There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. METHODS: A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. DISCUSSION: This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ( ANZCTR ) Registration date: 10/12/2018.

Incidence, severity and time course of pressure injuries over the first two years following discharge from hospital in people with spinal cord injuries in Bangladesh.

DESIGN: Cohort study embedded in a clinical trial. SETTING: Community, Bangladesh. OBJECTIVES: To determine the incidence, severity and time course of pressure injuries over the first two years following discharge from hospital in people with spinal cord injuries (SCI) in Bangladesh. METHODS: Participants (n = 186) were contacted by telephone 39 times and assessed face-to-face 4 to 6 times over the two years following discharge. At each point of contact the presence and severity of pressure injuries were determined using the Pressure Ulcer Scale for Healing (PUSH). Survival analyses were conducted to determine the time course of development of pressure injuries and recovery from pressure injuries. Lasso regression was used to construct multivariable prediction models. RESULTS: Seventy-seven participants (41%; 95% CI 34% to 49%) developed at least one pressure injury in the first two years after discharge (incidence rate 0.27 per person-year, 95% CI 0.22 to 0.34). Most pressure injuries were on the sacrum (23%). Pressure injuries took a median (IQR) of 40 (29 to 57) days to heal. The median (IQR) peak PUSH score was 11.0/17 (8.0 to 13.5). The multivariable prediction models had poor predictive properties (maximum c-statistic 0.75). CONCLUSION: Pressure injuries impose a large health burden on people with SCI in Bangladesh. However, they are difficult to predict, treat and prevent. Further research is needed to identify who is at most risk and to find solutions for the treatment and prevention of pressure injuries in Bangladesh and other low-middle income countries.

Do any physiotherapy interventions increase spinal cord independence measure or functional independence measure scores in people with spinal cord injuries? A systematic review.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine whether any physiotherapy interventions increase Spinal Cord Independence Measure or Functional Independence Measure scores (SCIM/FIM) in people with spinal cord injury (SCI), with the overall aim of determining whether any physiotherapy interventions need to be controlled for in studies examining the effects of novel experimental interventions on SCIM/FIM. METHODS: A systematic review was conducted to identify all randomised controlled trials examining the effect of any physiotherapy intervention on SCIM/FIM in people with SCI. PEDro scores were used to rate risk of bias. The results of similar trials and comparisons were pooled using meta-analyses. RESULTS: Thirty-three trials met the inclusion criteria but only 27 provided useable data. The median (IQR) PEDro score was 6.0 (4.0-7.0). A meta-analysis of four trials comparing robotic gait training with overground gait training that used a combination of FIM/SCIM indicated a pooled mean (95% CI) between-group difference of 0.38 standardised mean difference (SMD; 95% CI, 0.08-0.67). A second meta-analysis of two trials comparing upper limb training with and without functional electrical stimulation using FIM indicated a pooled (95% CI) between-group difference of 1.31 SMD (0.62-1.99). Another six trials examining a range of different physiotherapy interventions reported a statistically significant mean between-group difference on SCIM/FIM. CONCLUSION: There is low-quality evidence to indicate that a small number of physiotherapy interventions increase SCIM/FIM. The importance of controlling for all physiotherapy interventions in studies examining the effects of novel experimental interventions on SCIM/FIM is as yet unclear.

Face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: protocol of a multicentre, randomised controlled trial-the REFORM trial.

INTRODUCTION: Exercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise programme, while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively. METHODS AND ANALYSIS: The aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. Two hundred and ten participants will be recruited from five public hospitals in Sydney, Australia. Participants will be randomised to either the supported home exercise group or the face-to-face physiotherapy group. Participants allocated to the supported home exercise group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the face-to-face physiotherapy group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be nine secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome, and all analyses will be conducted on an intention-to-treat basis. A health economic evaluation will be conducted from a health funder plus patient perspective. ETHICS AND DISSEMINATION: Ethical approval was obtained on the 17 March 2017 from the Northern Sydney Local Health District HREC, trial number HREC/16HAWKE/431-RESP/16/287. The results of this study will be submitted for publication to peer-reviewed journals and be presented at national and international conferences. Recruitment commenced in March 2019, and it is anticipated that the trial will be completed by December 2021. This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions. TRIAL REGISTRATION NUMBER: CPMP/ICH-135/95. PROTOCOL VERSION: The most recent version of the protocol is V.1.2 dated November 2019.

Physiotherapy interventions for the treatment of spasticity in people with spinal cord injury: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine the effectiveness of physiotherapy interventions for the treatment of spasticity in people with spinal cord injuries. SETTING: Not applicable. METHODS: A comprehensive search was undertaken to identify all randomised controlled trials of physiotherapy interventions that included an assessor-reported (objective) or participant-reported (subjective) measure of spasticity. Only trials that provided a physiotherapy intervention on more than one occasion were included. The susceptibility to bias of each trial was rated on the PEDro scale. Data were extracted to derive mean between-group differences (95% CI) for each trial. RESULTS: Twenty-eight trials were identified but only 17 provided useable data. Seven trials compared a physiotherapy intervention to no intervention (or a sham intervention) and 10 trials compared one physiotherapy intervention to another physiotherapy intervention. The median (IQR) PEDro score of the 17 trials was 6/10 (6-8). The most commonly used assessor- and participant-reported measures of spasticity were the Ashworth scale and Spinal Cord Injury Spasticity Evaluation Tool, respectively. Only one trial demonstrated a treatment effect. This trial compared continuous passive motion of the ankle to no treatment on the Ashworth scale. The remaining 16 trials were either inconclusive or indicated that the treatment was ineffective for reducing spasticity. CONCLUSIONS: There is no high-quality evidence to indicate that physiotherapy interventions decrease spasticity but this may reflect a lack of research on the topic. Future trials should focus on participant-reported measures of spasticity that distinguish between the immediate, short-term and long-term effects of any physiotherapy intervention.

The cost of providing a community-based model of care to people with spinal cord injury, and the healthcare costs and economic burden to households of spinal cord injury in Bangladesh.

DESIGN: Descriptive. SETTING: Community, Bangladesh. OBJECTIVES: To determine the costs associated with providing a community-based model of care delivered as part of the CIVIC trial to people discharged from hospital with recent spinal cord injury (SCI), and to determine the economic burden to households. METHODS: Records were kept of the costs of providing a community-based model of care to participants of the CIVIC trial. Data were also collected at discharge and 2 years post discharge to capture out-of-pocket healthcare costs over the preceding 2 years, and the number of participants suffering catastrophic health expenditure and illness-induced poverty. RESULTS: The mean cost of providing the community-based model of care to participants assigned to the intervention group (n = 204) was US$237 per participant. The mean out-of-pocket healthcare cost over the first 2 years post discharge was US$472 per participant (n = 410), and US$448 per control participant (n = 206). Median (IQR) equivalent annual household incomes prior to SCI and at 2 years post discharge were US$721 (US$452-1129) and US$464 (US$214-799), respectively. Of the 378 participants alive at 2 years, 324 (86%) had catastrophic health expenditure, and 161 of 212 participants who were not in poverty prior to injury (76%) were pushed into illness-induced poverty within 2 years of injury. CONCLUSION: The cost of providing community-based support to people with SCI for 2 years post discharge in Bangladesh is relatively inexpensive but an overwhelming majority of households rapidly experience financial catastrophe, and most fall into poverty.

A community-based intervention to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh (CIVIC): a randomised trial.

STUDY DESIGN: Randomised controlled trial. OBJECTIVES: To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh. SETTING: Bangladesh. METHODS: A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation. RESULTS: Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications. CONCLUSION: A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.

International Spinal Cord Injury Physical Therapy-Occupational Therapy Basic Data Set (Version 1.2).

STUDY DESIGN: Expert workgroup consensus, focused literature review, and vetting via feedback from international presentations and spinal cord professional membership groups. OBJECTIVES: Develop and refine a basic dataset to enable standardized documentation of physical therapy (PT) and occupational therapy (OT) interventions delivered in a controlled clinical trial intended to improve voluntary motor function. SETTING: International Expert Working Group. METHODS: An international working group with expertise in spinal cord injury, PT, OT, and measurement developed a draft of the International Spinal Cord Injury (ISCI) Physical Therapy-Occupational Therapy (PT-OT) Basic Data Set (BDS). Emphasis was placed on efficiency and practicality of use. The BDS was iteratively refined based on applicable literature, and feedback collected from presentations at the 2017 and 2019 International Spinal Cord Society meetings. RESULTS: The ISCI PT-OT BDS contains seven broad categories of interventions: bed/seated mobility, standing activities, walking/stairs, gross motor upper extremity, fine motor upper extremity, strength training, and endurance training. The first five categories are classified as activity-directed and the last two as impairment-directed interventions. Time spent on interventions per category is recorded in 15-min intervals. CONCLUSIONS: The ISCI PT-OT BDS enables standardized documentation of PT-OT activity-directed or impairment-directed interventions. The ISCI PT-OT BDS is a documentation tool to facilitate evaluation of the influence of rehabilitation therapies on motor function in clinical trials of biologic or pharmacologic agents or rehabilitation technologies that are delivered in the clinical setting.