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.

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).

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).

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.

The effects of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury: a randomised controlled trial.

STUDY DESIGN: A multi-centred, single-blinded randomised controlled trial. OBJECTIVES: To determine the effect of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury (SCI). SETTINGS: Seven hospitals in Australia and Asia. METHODS: One hundred and twenty people with recent SCI undergoing inpatient rehabilitation were randomised to either a Treatment or Control Group. One major muscle group from an upper or lower limb was selected if the muscle had grade 1 or grade 2 strength on a standard six-point manual muscle test. Participants allocated to the Treatment Group performed 10,000 isolated contractions of the selected muscle group, as well as usual care in 48 sessions over 8 weeks. Participants allocated to the Control Group received usual care alone. Participants were assessed at baseline and 8 weeks by a blinded assessor. The primary outcome was voluntary muscle strength on a 13-point manual muscle test. There were three secondary outcomes capturing therapists' and participants' perceptions of strength and function. RESULTS: The mean between-group difference of voluntary strength at 8 weeks was 0.4/13 points (95% confidence interval -0.5 to 1.4) in favour of the Treatment Group. There were no notable between-group differences on any secondary outcome. CONCLUSION: Ten thousand isolated contractions of very weak muscles in people with SCI over 8 weeks has either no or a very small effect on voluntary strength.

Functional electrical stimulation cycling has no clear effect on urine output, lower limb swelling, and spasticity in people with spinal cord injury: a randomised cross-over trial.

QUESTION: Does functional electrical stimulation (FES) cycling increase urine output and decrease lower limb swelling and spasticity in people with recent spinal cord injury? DESIGN: Randomised cross-over trial. PARTICIPANTS: Fourteen participants with a recent motor complete spinal cord injury were consecutively recruited from two spinal cord injury units in Sydney. INTERVENTION: Participants were randomised to an experimental phase followed by a control phase or vice versa, with a 1-week washout period in between. The experimental phase involved FES cycling four times a week for two weeks and the control phase involved standard rehabilitation for two weeks. Assessments by a blinded assessor occurred at the beginning and end of each phase. Allocation was concealed and an intention-to-treat analysis was performed. OUTCOME MEASURES: The primary outcome was urine output (mL/hr) and the secondary outcomes were lower limb circumference, and spasticity using the Ashworth Scale, and the Patient Reported Impact of Spasticity Measure (PRISM). In addition, participants were asked open-ended questions to explore their perceptions about treatment effectiveness. RESULTS: All participants completed the study. The mean between-group difference (95% CI) for urine output was 82mL/hr (-35 to 199). The mean between-group differences (95% CI) for lower limb swelling, spasticity (Ashworth), and PRISM were -0.1cm (-1.5 to 1.2), -1.9 points (-4.9 to 1.2) and -5 points (-13 to 2), respectively. All point estimates of treatment effects favoured FES cycling. Participants reported many benefits from FES cycling. CONCLUSION: There were no clear effects of FES cycling on urine output, swelling and spasticity even though all point estimates of treatment effects favoured FES cycling and participants perceived therapeutic effects. TRIAL REGISTRATION: ACTRN12611000923965.

Physical therapists' ability to predict future mobility after spinal cord injury.

BACKGROUND AND PURPOSE: Goal setting is an important aspect of any physical therapy program. It not only determines the focus of therapy but also determines discharge planning and equipment prescription. The effectiveness of goal setting is dependent on therapists' ability to predict patients' future mobility. The purpose of this study was to determine how accurately physical therapists can predict the future mobility of people with spinal cord injuries (SCI) at the time of admission to rehabilitation. METHODS: A cohort observational study was undertaken in 2 SCI units in Sydney, Australia, where a consecutive series of 50 patients admitted for rehabilitation was recruited. At the time of admission to rehabilitation, treating therapists predicted each patient's likely future mobility. Therapists used standardized assessment scales that captured ability to mobilize in a wheelchair, transfer, move in bed, and walk. After 3 months of standard in-patient rehabilitation, patients were reassessed by blinded assessors using the same scales. Therapists' predictions on admission were compared with patients' outcomes at 3 months. RESULTS: There was a strong positive correlation between therapists' predictions on admission and patients' outcomes at 3 months (r = 0.53-0.92). Therapists' predictions were within 1 point of patient outcomes between 60% and 78% of the time. DISCUSSION AND CONCLUSION: Physical therapists are able to accurately predict future mobility of people with SCI at the time of admission to rehabilitation. Ability to accurately predict future mobility is necessary for goal setting and for ensuring that therapy, discharge planning, and equipment prescription are appropriate. These findings are important because they indicate how much confidence patients, funders, policy makers, and administrators can have in therapists' ability to predict patients' future mobility.

Training unsupported sitting does not improve ability to sit in people with recently acquired paraplegia: a randomised trial.

QUESTION: Do people with recently acquired paraplegia benefit from a six-week motor retraining program aimed at improving their ability to sit unsupported? DESIGN: A randomised controlled trial with concealed allocation, assessor blinding, and intention-totreat analysis. PARTICIPANTS: 32 people with recently acquired paraplegia and limited ability to sit unsupported. INTERVENTION: All participants undertook standard inpatient rehabilitation over a six-week period. Experimental participants received three additional 30-minute sessions per week of motor retraining directed at improving their ability to sit unsupported. OUTCOME MEASURES: The three primary outcomes were the Maximal Lean Test, Maximal Sideward Reach Test, and the Performance Item of the Canadian Occupational Performance Measure (COPM). The secondary outcomes were the Satisfaction Item of the COPM, Participants' Impressions of Change, Clinicians' Impressions of Change, the T-shirt Test, and the Spinal Cord Injury Falls Concern Scale. RESULTS: The mean between-group differences for the Maximal Lean Test, Maximal Sideward Reach Test and the Performance Item of the COPM were -20 mm (95% CI -64 to 24), 5% arm length (95% CI -3 to 13) and 0.5 points (95% CI -0.5 to 1.5), respectively. The secondary outcomes did not differ significantly between groups. CONCLUSION: People with recently acquired paraplegia do not benefit from a six-week motor retraining program directed specifically at improving their ability to sit unsupported. Their ability to sit unsupported does, however, improve over time, suggesting that the practice of activities of daily living has important carry-over effects on unsupported sitting, rendering additional training redundant. TRIAL REGISTRATION: ACTRN12608000464369.

Contracture management for people with spinal cord injuries.

Contractures are a common and disabling problem for people with spinal cord injuries. To date, contractures have largely been managed with physical interventions such as stretch and passive movements. These are typically administered either manually or with the assistance of various orthoses, devices or aids. However, the results of recent clinical trials question the effectiveness of these interventions. They indicate that therapists should not expect to see a change in joint mobility or muscle extensibility from stretches applied for less than 30 minutes a day over less than 3 months. This suggests that contractures may be a far more complex and multifactorial problem to manage than previously assumed. This paper challenges clinicians and researchers to reappraise the effectiveness of current contracture management.

A new clinical device for measuring wrist strength in people with tetraplegia.

Weakness of wrist muscles has a significant impact on upper limb function in people with tetraplegia. A simple device has been designed to enable clinicians to measure dynamic strength in the very weak muscles of people with tetraplegia. The objective of this study was to test the interrater reliability of the device. Twenty wrists of 12 people with tetraplegia and associated wrist extensor weakness (grade 2-4) were included in the study. The strength of the wrist extensor muscles was measured by blinded assessors on two separate occasions 1-3 days apart. Measurements were conducted in a device that ensured the resistive torque was constant as the wrist moved through full range of motion. Intraclass correlation coefficients and percent close agreement scores were used to measure reliability. The intraclass correlation coefficient was 0.88 (95% CI 0.72-0.95). Repeat measurements of wrist extensor torque were within 0.5 Nm 75% of the time and 0.7 Nm 90% of the time. This device is a simple and reliable way of measuring dynamic wrist extensor strength of people with tetraplegia. It is appropriate for use in the clinical setting.

Does 12 weeks of regular standing prevent loss of ankle mobility and bone mineral density in people with recent spinal cord injuries?

The purpose of this study was to determine the effects of a 12-week standing program on ankle mobility and femur bone mineral density in patients with lower limb paralysis following recent spinal cord injury. An assessor-blinded within-subject randomised controlled trial was undertaken. Twenty patients with lower limb paralysis following a recent spinal cord injury were recruited. Subjects stood weight-bearing through one leg on a tilt-table for 30 minutes, three times each week for 12 weeks. By standing on one leg a large dorsiflexion stretch was applied to the ankle and an axial load was applied to the bones of the weight-bearing leg. Ankle mobility and femur bone mineral density of both legs were measured at the beginning and end of the study. Ankle mobility (range of motion) was measured with the application of a 17 Nm dorsiflexion torque. Femur bone mineral density was measured using dual energy X-ray absorptiometry (DEXA). The effect of standing was estimated from the difference between legs in mean change of ankle mobility and femur bone mineral density. The results indicated a mean treatment effect on ankle mobility of 4 degrees (95% CI 2 to 6 degrees) and on femur bone mineral density of 0.005 g/cm(2) (95% CI -0.015 to 0.025 g/cm(2)). Tilt-table standing for 30 minutes, three times per week for 12 weeks has a small effect on ankle mobility, and little or no effect on femur bone mineral density. It is unclear whether clinicians and patients would consider such effects to be clinically worthwhile.