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.

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.

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.

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.

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.

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.

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.

Does regular standing improve bowel function in people with spinal cord injury? A randomised crossover trial.

STUDY DESIGN: A randomised crossover trial. OBJECTIVES: To determine the effects of a 6-week standing programme on bowel function in people with spinal cord injury. SETTING: Community, Australia and the United Kingdom. METHODS: Twenty community-dwelling people with motor complete spinal cord injury above T8 participated in a 16-week trial. The trial consisted of a 6-week stand phase and a 6-week no-stand phase separated by a 4-week washout period. Participants were randomised to one of two treatment sequences. Participants allocated to the Treatment First group stood on a tilt table for 30 min per session, five times per week for 6 weeks and then did not stand for the next 10 weeks. Participants allocated to the Control First group did the opposite: they did not stand for 10 weeks and then stood for 6 weeks. Participants in both groups received routine bowel care throughout the 16-week trial. Assessments occurred at weeks 0, 7, 10 and 17 corresponding with pre and post stand and no-stand phases. The primary outcome was Time to First Stool. There were seven secondary outcomes reflecting other aspects of bowel function and spasticity. RESULTS: There were three dropouts leaving complete data sets on 17 participants. The mean (95% confidence interval) between-intervention difference for Time to First Stool was 0 min (-7 to 7) indicating no effect of regular standing on Time to First Stool. CONCLUSION: Regular standing does not reduce Time to First Stool. Further trials are required to test the veracity of some commonly held assumptions about the benefits of regular standing for bowel function.

A massive open online course for teaching physiotherapy students and physiotherapists about spinal cord injuries.

STUDY DESIGN: A descriptive audit. OBJECTIVES: To audit the participation and satisfaction in a Massive Open Online Course (MOOC) for teaching physiotherapy students and physiotherapists about spinal cord injuries. SETTING: Global and online. METHODS: A 5-week MOOC about the physiotherapy management of spinal cord injuries was hosted by Physiopedia and run in partnership with the International Spinal Cord Society. The MOOC was based on the physiotherapy-specific module of www.elearnSCI.org, and also involved extra readings, activities and online discussion through a closed Facebook group. Participation and satisfaction was quantified through a pre- and post-MOOC knowledge assessment and an online course evaluation. Participation was also gauged through Facebook activity and internet-based usage statistics. RESULTS: Three thousand five hundred and twenty-three people from 108 countries registered for the MOOC and 2527 joined the Facebook group. One thousand one hundred and twenty-one completed the pre- and post-MOOC knowledge assessments, with more completing one or the other. The median (interquartile range) results for those who completed the pre and post-MOOC knowledge assessments were 70% (60-80%) and 90% (80-95%), respectively. One thousand and twenty-nine completed the online course evaluation, with more than 80% agreeing or strongly agreeing with 12 of the 13 positive statements posed to them about the course. CONCLUSION: Most participants who completed the MOOC performed well on the post-MOOC knowledge assessment and enjoyed the learning experience. However, these results may be biased if those who did not complete the MOOC were dissatisfied and/or did not sit the post-MOOC knowledge assessment.

How well do randomised controlled trials of physical interventions for people with spinal cord injury adhere to the CONSORT guidelines? An analysis of trials published over a 10-year period.

STUDY DESIGN: Cross-sectional descriptive study of randomised controlled trials involving physical interventions for people with spinal cord injury (SCI) published between 2003 and 2013. OBJECTIVES: To determine how well randomised controlled trials of physical interventions for people with SCI adhere to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. SETTING: University of Sydney, Sydney, NSW, Australia. METHODS: A search was conducted for randomised controlled trials designed to determine the effectiveness of physical interventions for people with SCI published between 2003 and 2013. The CONSORT checklist for the reporting of randomised controlled trials was used to determine how well each trial adhered to the guidelines. Two independent reviewers rated each trial on each of the 37 items on the CONSORT checklist using the following criteria: 'fully reported', 'partially reported', 'not reported', 'not relevant' or 'not reported but unable to determine if relevant/done'. RESULTS: Fifty-three trials were retrieved. None of the trials 'fully reported' all items of the CONSORT guidelines. The median (IQR) number of items that was 'fully reported' was 11/37 (7-20). The median (IQR) number of items that was either 'fully reported' or 'not relevant' or 'not reported but unable to determine if relevant' was 20/37 items (17-27). CONCLUSION: The reporting of randomised controlled trials in SCI is only partially adhering to the CONSORT guidelines. Journals can help lift standards by encouraging authors of randomised controlled trials to adhere to the CONSORT guidelines.

www.elearnSCI.org: a global educational initiative of ISCoS.

OBJECTIVE: To develop a web-based educational resource for health professionals responsible for the management of spinal cord injury (SCI). The resource:www.elearnSCI.org is comprised of seven learning modules, each subdivided into various submodules. Six of the seven modules address the educational needs of all disciplines involved in comprehensive SCI management. The seventh module addresses prevention of SCI. Each submodule includes an overview, activities, self-assessment questions and references. DEVELOPMENT OF THE RESOURCE: Three hundred and thirty-two experts from The International Spinal Cord Society (ISCoS) and various affiliated societies from 36 countries were involved in developing the resource through 28 subcommittees. The content of each submodule was reviewed and approved by the Education and Scientific Committees of ISCoS and finally by an Editorial Committee of 23 experts. KEY FEATURES: The content of the learning modules is relevant to students and to new as well as experienced SCI healthcare professionals. The content is applicable globally, has received consumer input and is available at no cost. The material is presented on a website underpinned by a sophisticated content-management system, which allows easy maintenance and ready update of all the content. The resource conforms to key principles of e-learning, including appropriateness of curriculum, engagement of learners, innovative approaches, effective learning, ease of use, inclusion, assessment, coherence, consistency, transparency, cost effectiveness and feedback. CONCLUSION: www.elearnSCI.org provides a cost effective way of training healthcare professionals that goes beyond the textbook and traditional face-to-face teaching.

Electrical stimulation plus progressive resistance training for leg strength in spinal cord injury: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To determine the effectiveness of electrical stimulation (ES)-evoked muscle contractions superimposed on progressive resistance training (PRT) for increasing voluntary strength in the quadriceps muscles of people with spinal cord injuries (SCI). SETTING: Sydney, Australia. METHODS: A total of 20 people with established SCI and neurologically induced weakness of the quadriceps muscles participated in the trial. Participants were randomized between experimental and control groups. Volunteers in the experimental group received ES superimposed on PRT to the quadriceps muscles of one leg thrice weekly for 8 weeks. Participants in the control group received no intervention. Assessments occurred at the beginning and at the end of the 8-week period. The four primary outcomes were voluntary strength (Nm) and endurance (fatigue ratio) as well as the performance and satisfaction items of the Canadian Occupational Performance Measure (COPM; points). RESULTS: The between-group mean differences (95% confidence interval (CI)) for voluntary strength and endurance were 14 Nm (1-27; P=0.034) and 0.1 (-0.1 to 0.3; P=0.221), respectively. The between-group median differences (95% CI) for the performance and satisfaction items of the COPM were 1.7 points (-0.2 to 3.2; P=0.103) and 1.4 points (-0.1 to 4.6; P=0.058), respectively. CONCLUSION: ES superimposed on PRT improves voluntary strength, although there is uncertainty about whether the size of the treatment effect is clinically important. The relative effectiveness of ES and PRT is yet to be determined.

The effectiveness of physical interventions for people with spinal cord injuries: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVES: To provide a quantitative analysis of all randomized controlled trials designed to determine the effectiveness of physical interventions for people with spinal cord injury (SCI). SETTING: Sydney, Australia. METHODS: A search was conducted for randomized controlled trials involving physical interventions for people with SCI. Two reviewers independently rated methodological quality using the PEDro scale and extracted key findings from the trials. RESULTS: Four thousand five hundred and forty three abstracts were identified of which 31 trials met the inclusion criteria. Trials examined the effectiveness of fitness and strength training (n=7), gait training (n=5), hand therapy (n=3), stretch (n=4), acupuncture (n=3), hand splinting (n=2) and other related therapies (n=7). Six trials reported a between-group mean difference with a clearly important treatment effect on at least one outcome measure. These trials supported the use of fitness, strength and gait training as well as acupuncture. CONCLUSION: There is initial evidence supporting the effectiveness of some physical interventions for people with SCI. However, there is a pressing need for high-quality trials to determine the effectiveness of all physical interventions commonly administered in clinical practice.

Effects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury: a randomized controlled trial.

STUDY DESIGN: Assessor-blinded within-subject randomized controlled trial. OBJECTIVE: To determine the effects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury. SETTING: Community, Australia. METHODS: A total of 20 people with tetraplegia living in the community had one ankle randomized to a control group and the other to an experimental group. Carers administered passive movements to participants' experimental ankles for 10 min, 10 times a week for 6 months. The control ankles were left untreated. The primary outcome was passive ankle dorsiflexion range of motion. RESULTS: Adherence was high (mean adherence rate of 96%). Ankle dorsiflexion range of motion decreased by a mean (s.d.) of 2 degrees (4) in control ankles and increased by 2 degrees (4) in experimental ankles. The mean (95% confidence interval, CI) effect on ankle dorsiflexion range of motion was 4 degrees (95% CI, 2-6 degrees ). CONCLUSION: Regular passive movements have small effects on ankle joint mobility. It is unclear if these effects are clinically worthwhile.

Quantifying the passive extensibility of the flexor pollicis longus muscle in people with tetraplegia.

STUDY DESIGN: Repeat measures design. OBJECTIVE: The purpose of this study was firstly, to describe a simple clinical tool that can be used to measure the extensibility of the flexor pollicis longus (FPL) muscle; secondly, to test its reliability; and thirdly, to attain some 'normative' data of the extensibility of the FPL muscle in a representative sample of people with tetraplegia. SETTING: A spinal cord injury unit in Sydney. SUBJECTS: A total of 37 people (62 hands) with C4-C7 tetraplegia. MAIN OUTCOME MEASURES: Angle of the carpometacarpal (CMC) joint of the thumb was measured in all subjects with the application of a series of thumb extensor torques. A device specifically designed for this purpose was used to standardize the torque and objectively quantify the CMC joint angle. In addition, repeat measurements were taken 3-5 days later in one subgroup of 13 subjects (one hand per subject) and 3 months later in another subgroup of 13 subjects (one hand per subject). ANALYSIS: Intraclass correlation coefficients and percent close agreement scores were derived to quantify the 3-5 days and 3-month reliability between repeat measurements. RESULTS: The median CMC angle of the thumb with the application of a 0.044 Nm torque was 63 degrees (range, 20-93 degrees). The intraclass correlation coefficients with the application of a 0.044 Nm torque were 0.88 (95% CI, 0.65-0.96) for measurements taken 3-5 days apart, and 0.90 (95% CI, 0.67-0.97) for measurements taken 3 months apart. CONCLUSION: This study describes a simple and reliable way of measuring the extensibility of the FPL muscle in people with tetraplegia. This assessment tool and the 'normative' data provided in this study can be used to further investigate the contribution of the passive mechanical properties of the FPL muscle to hand function of people with C6 and C7 tetraplegia.

Reliability of a device designed to measure ankle mobility.

STUDY DESIGN: Repeated measures design. OBJECTIVE: To assess the reliability of a device designed to measure ankle mobility in the clinical setting. SETTING: Spinal Cord Injury Unit, Sydney, Australia. METHODS: Consecutive sample of 15 patients with paraplegia and tetraplegia with injuries of less than 1 year duration was studied. Ankle mobility was measured on two separate occasions 2 or 3 days apart. Stretch torque was standardised and ankle range of motion measured with an inclinometer attached to the footplate. Intraclass correlation coefficients and percent close agreement scores were used to assess agreement between mean measurements obtained on days 1 and 2. RESULTS: The intraclass correlation coefficient was 0.95 (95% CI, 0.91-0.98). Measurements obtained on day 1 were within 3 degrees of the measurements obtained on day 2 77% of the time and within 6 degrees 97% of the time. CONCLUSION: The footplate is a reliable and simple way to measure ankle mobility in people with spinal cord injuries.