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.

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.

Health status, quality of life and socioeconomic situation of people with spinal cord injuries six years after discharge from a hospital in Bangladesh.

STUDY DESIGN: Cross-sectional analysis of a mixed retrospective and prospective inception cohort study. OBJECTIVES: To determine health status, quality of life and socioeconomic situation of people with spinal cord injuries (SCI) 6 years after discharge from a hospital in Bangladesh. SETTING: Bangladesh. METHODS: All patients alive 6 years after discharge from a hospital in Bangladesh were interviewed using the SF12 health survey, the SCI Secondary Conditions Scale, the Centre for Epidemiologic Studies Depression Scale (CESD), and the participation in society items of World Health Organisation Disability Assessment Schedule (WHODAS 2.0). Additional questions determined participants' socioeconomic and employment status. RESULTS: The cohort comprised 260 participants: 145 used wheelchairs for mobility and 115 were able to walk at discharge. The median (IQR) Mental and Physical Component scores for the SF12 were 54 (49-57) and 44 (40-51) points, respectively. The median scores for the SCI Secondary Conditions Scale, CESD and WHODAS 2.0 were 8 (4-13), 7 (4-13) and 12 (6-17) points, respectively. Fourteen percent of all participants and 23% of those who used wheelchairs had a pressure ulcer at the time of interview. Forty-four percent of participants were unemployed and 65% were living below the poverty line (median (IQR) income, USD 0 (0-91)) per month. CONCLUSION: Many people with SCI in Bangladesh are unemployed and living in poverty with a reduced quality of life and participation. Pressure ulcers are a common complication.

Protocol for process evaluation of CIVIC randomised controlled trial: Community-based InterVentions to prevent serIous Complications following spinal cord injury in Bangladesh.

INTRODUCTION: People with spinal cord injuries in low-income and middle-income countries are highly vulnerable to life-threatening complications in the period immediately after discharge from hospital. We are conducting a randomised controlled trial in Bangladesh to determine whether all-cause mortality at 2 years can be reduced if health professionals regularly ring and visit participants in their homes following discharge. We will conduct a process evaluation alongside the trial to explain the trial results and determine the feasibility of scaling this intervention up in low-income and middle-income countries if it is found to be effective. METHODS AND ANALYSIS: Our process evaluation is based on the Realist and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks. We will use a mixed methods approach that uses both qualitative and quantitative data. For example, we will audit a sample of telephone interactions between intervention participants and the healthcare professionals, and we will conduct semistructured interviews with people reflective of various interest groups. Quantitative data will also be collected to determine the number and length of interactions between the healthcare professionals and participants, the types of issues identified during each interaction and the nature of the support and advice provided by the healthcare professionals. All quantitative and qualitative data will be analysed iteratively before the final analysis of the trial results. These data will then be triangulated with the final results of the primary outcome. ETHICS AND DISSEMINATION: Ethics approval was obtained from the institutional ethics committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval and the relevant regulatory bodies. The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12615000630516.

Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India.

INTRODUCTION: We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting. METHODS AND ANALYSIS: The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation. ETHICS AND DISSEMINATION: The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation. TRIAL REGISTRATION NUMBER: CTRI/2013/04/003557.

Community-based InterVentions to prevent serIous Complications (CIVIC) following spinal cord injury in Bangladesh: protocol of a randomised controlled trial.

INTRODUCTION: In low-income and middle-income countries, people with spinal cord injury (SCI) are vulnerable to life-threatening complications after they are discharged from hospital. The aim of this trial is to determine the effectiveness and cost-effectiveness of an inexpensive and sustainable model of community-based care designed to prevent and manage complications in people with SCI in Bangladesh. METHODS AND ANALYSIS: A pragmatic randomised controlled trial will be undertaken. 410 wheelchair-dependent people with recent SCI will be randomised to Intervention and Control groups shortly after discharge from hospital. Participants in the Intervention group will receive regular telephone-based care and three home visits from a health professional over the 2 years after discharge. Participants in the Control group will receive standard care, which does not involve regular contact with health professionals. The primary outcome is all-cause mortality at 2 years. Recruitment started on 12 July 2015 and the trial is expected to take 5 years to complete. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Ethics Committee at the site in Bangladesh and from the University of Sydney, Australia. The study will be conducted in compliance with all stipulations of its protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007), the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95) and the Bangladesh Guidance on Clinical Trial Inspection (2011). The results of the trial will be disseminated through publications in peer-reviewed scientific journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBERS: ACTRN12615000630516, U1111-1171-1876.

FAmily-Led RehabiliTaTion aftEr Stroke in INDia: the ATTEND pilot study.

BACKGROUND: The aim of this pilot study was to determine the feasibility of a multicenter, randomized, controlled trial in India of a family-led, trained caregiver-delivered, home-based rehabilitation intervention vs. routine care. METHODS: A prospective, randomized (within seven-days of hospital admission), blinded outcome assessor, controlled trial of structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control) was conducted in patients with residual disability. Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months. CTRI/2014/10/005133. RESULTS: A total of 104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months. Recruitment was feasible and accepted by patients and their carers. Important observations were made regarding potential unblinding of the participants, contamination of therapy between the randomized groups, organization of home visits, and resources required for a multicenter study. CONCLUSION: The pilot study established the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation in a low resource setting. The main phase of the trial 'ATTEND' is currently underway in over 10 centers in India.

Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial.

BACKGROUND: Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. METHODS/DESIGN: A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. DISCUSSION: The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. TRIAL REGISTRATION: NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009).

Effectiveness of stretch for the treatment and prevention of contractures in people with neurological conditions: a systematic review.

BACKGROUND: Contractures are a disabling complication of neurological conditions that are commonly managed with stretch. OBJECTIVE: The purpose of this systematic review was to determine the effectiveness of stretch for the treatment and prevention of contractures. The review is part of a more-detailed Cochrane review. Only the results of the studies including patients with neurological conditions are reported here. DATA SOURCES: Electronic searches were conducted in June 2010 in the following computerized databases: Cochrane CENTRAL Register of Controlled Trials, Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database (HTA), MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, SCI-EXPANDED, and Physiotherapy Evidence Database (PEDro). STUDY ELIGIBILITY CRITERIA: The review included randomized controlled trials and controlled clinical trials of stretch applied for the purposes of treating or preventing contractures in people with neurological conditions. STUDY APPRAISAL AND SYNTHESIS METHODS: Two reviewers independently selected studies, extracted data, and assessed risk of bias. The primary outcome measures were joint mobility (range of motion) and quality of life. Secondary outcome measures were pain, spasticity, activity limitation, and participation restriction. Meta-analyses were conducted using random-effects models. RESULTS: Twenty-five studies met the inclusion criteria. These studies provide moderate-quality evidence that stretch has a small immediate effect on joint mobility (mean difference=3°, 95% confidence interval [CI]=0° to 5°) and high-quality evidence that stretch has little or no short-term or long-term effects on joint mobility (mean difference=1° and 0°, respectively, 95% CI=0° to 3° and -2° to 2°, respectively). There is little or no effect of stretch on pain, spasticity, and activity limitation. LIMITATIONS: No studies were retrieved that investigated the effects of stretch for longer than 6 months. CONCLUSION: Regular stretch does not produce clinically important changes in joint mobility, pain, spasticity, or activity limitation in people with neurological conditions.

Validity and reliability of assessment tools for measuring unsupported sitting in people with a spinal cord injury.

OBJECTIVES: To develop simple tests to assess the abilities of people with spinal cord injury (SCI) to sit unsupported and to assess the construct validity and test-retest reliability of these tests. DESIGN: Cross-sectional comparisons, convenience sample. SETTING: Biomechanical laboratory. PARTICIPANTS: People (N=30) with SCI between the C6 and the L2 level of 2 months to 37 years duration before assessment. The sample was stratified by impairment level (at T8) and time since injury (1 y postinjury). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: On 2 separate occasions, participants performed tests that measured the distance of upper-body sway and maximal torso leaning, errors made during a coordinated stability task, timed dressing/undressing of the upper body and alternating arm reaching, and percentage change in seated upper body/arm reaching. RESULTS: All tests showed good construct validity in that they distinguished between participants with higher (C6-T7) and lower (T8-L2) level impairments (P<.05) and between participants with acute (< or =1 y) and chronic (>1 y) lesions (P<.05). The tests also showed good to excellent test-retest reliability (intraclass correlation coeffiecient(3,1) range, .51-.91). CONCLUSIONS: These simple and quick-to-administer tests have both construct validity and test-retest reliability. They would be appropriate for research and clinical purposes to quantify the abilities of people with SCI to sit unsupported.