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).

Motor training programs of arm and hand in patients with MS according to different levels of the ICF: a systematic review.

BACKGROUND: The upper extremity plays an important role in daily functioning of patients with Multiple Sclerosis (MS) and strongly influences their quality of life. However, an explicit overview of arm-hand training programs is lacking. The present review aims to investigate the training components and the outcome of motor training programs for arm and hand in MS. METHODS: A computerized systematic literature search in 5 databases (PubMed, CINAHL, EMBASE, PEDro and Cochrane) was performed using the following Mesh terms: Multiple Sclerosis, Rehabilitation, Physical Education and Training, Exercise, Patient-Centered Care, Upper Extremity, Activities of Daily Living, Motor Skills, Motor Activity, Intervention Studies and Clinical Trial. The methodological quality of the selected articles was scored with the Van Tulder Checklist. A descriptive analyses was performed using the PICO principle, including scoring of training components with the calculation of Hedges'g effect sizes. RESULTS: Eleven studies were eligible (mean Van Tulder-score = 10.82(SD2.96)). Most studies reported a specific improvement in arm hand performance at the ICF level that was trained at. The mean number of training components was 5.5(SD2.8) and a significant correlation (r = 0.67; p < 0.05) between the number of training components and effect sizes was found. The components 'client-centered' and 'functional movement' were most frequently used, whereas 'distribution based practice', 'feedback' and 'random practice' were never used. The component 'exercise progression' was only used in studies with single ICF body function training, with the exception of 1 study with activity level training. Studies including the component 'client-centred' demonstrated moderate to high effect sizes. CONCLUSION: Motor training programs (both at the ICF body function and activity level) have shown to improve arm and hand performance in MS in which the value of the training specificity was emphasized. To optimize upper extremity training in MS the component 'client-centred' and 'exercise progression' may be important. Furthermore, given the importance attributed to the components 'distribution based practice', 'feedback' and 'random practice' in previous research in stroke patients, the use of these components in arm hand training should be explored in future research.

Influence of task-oriented training content on skilled arm-hand performance in stroke: a systematic review.

OBJECTIVE: This review evaluates the underlying training components currently used in task-oriented training and assesses the effects of these components on skilled arm-hand performance in patients after a stroke. METHODS: A computerized systematic literature search in 5 databases (PubMed, CINAHL, EMBASE, PEDro, and Cochrane) identified randomized clinical trials, published through March 2009, evaluating the effects of task-oriented training. Relevant article references listed in publications included were also screened. The methodological quality of the selected studies was assessed with the Van Tulder Checklist. For each functional outcome measure used, the effect size (bias corrected Hedges's g) was calculated. RESULTS: The intervention results in 528 patients (16 studies) were studied. From these, 15 components were identified to characterize task-oriented training. An average of 7.8 (standard deviation = 2.1) components were used in the included trials. There was no correlation between the number of task-oriented training components used in a study and the treatment effect size. "Distributed practice" and "feedback" were associated with the largest postintervention effect sizes. "Random practice" and "use of clear functional goals" were associated with the largest follow-up effect sizes. CONCLUSION: The task-oriented training was operationalized with 15 components. The number of components used in an intervention aimed at improving arm-hand performance after stroke was not associated with the posttreatment effect size. Certain components, which optimize storage of learned motor performance in the long-term memory, occurred more in studies with larger treatment effects.

Outcome of motor training programmes on arm and hand functioning in patients with cervical spinal cord injury according to different levels of the ICF: a systematic review.

OBJECTIVE: To investigate the outcome of motor training programmes on arm and hand functioning in patients with cervical spinal cord injury according to different levels of the International Classification of Functioning, Disability and Health (ICF). DESIGN: Systematic review. METHODS: A search of the following databases: Medline, Cochrane, Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, Physiotherapy Evidence Database (PEDro) and Database of Abstracts of Reviews of Effects (DARE) from 1976 to August 2008 was performed using the following MeSH terms: Spinal Cord Injuries, Quadriplegia, Rehabilitation, Physical Education and Training, Exercise, Patient-Centered Care, Upper Extremity, Activities of Daily Living, Motor Skills, Motor Activity, Intervention Studies, Clinical Trial. The methodological quality of the selected articles was scored with the Van Tulder Checklist. Descriptive analyses were performed using the PICO principle (Patient characteristics, Intervention, Comparison, Outcome & results) along the ICF function and activity level. RESULTS: Twelve studies were included in the analyses. Overall, the methodological quality of the studies was acceptable, with a mean Van Tulder score of 9.58. Interventions included motor training programmes at the level of function, activity or a combined programme. Most studies reported improvements in arm and hand functioning at the level that was trained for. CONCLUSION: Motor training programmes may improve arm and hand functioning at function and/or activity level in cervical spinal cord injured patients. However, no general conclusion based on a meta-analysis can be drawn due to the wide variety of approaches.

Rehabilitation outcome of upper extremity skilled performance in persons with cervical spinal cord injuries.

OBJECTIVE: To investigate changes in arm hand skilled performance during and after active rehabilitation in (sub)groups of subjects with cervical spinal cord injuries. DESIGN: Longitudinal multi-centre cohort study. PATIENTS: Persons with cervical spinal cord injuries during (n?=?57) and after (n?=?35) rehabilitation. METHODS: Patients from 8 Dutch rehabilitation centres received therapy as usual. At 3 time-points during active rehabilitation and one year after discharge arm hand skilled performance was measured using the Van Lieshout hand function test, the Grasp Release Test (for basic activities) and the Functional Independence Measure and the Quadriplegia Index of Function (for complex activities). RESULTS: Arm hand skilled performance continues to improve over the entire rehabilitation period, mostly in the first stage of active rehabilitation, and especially in persons with a motor incomplete lesion. Persons with a motor incomplete lesion achieve higher arm hand skilled performance outcome than those with a motor complete lesion. After rehabilitation arm hand skilled performance does not decline. CONCLUSION: Monitoring the outcome of arm hand skilled performance at the level of basic and complex activities during the whole rehabilitation phase may guide therapists in further optimizing therapy.