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.

DiSCIoser: unlocking recovery potential of arm sensorimotor functions after spinal cord injury by promoting activity-dependent brain plasticity by means of brain-computer interface technology: a randomized controlled trial to test efficacy.

BACKGROUND: Traumatic cervical spinal cord injury (SCI) results in reduced sensorimotor abilities that strongly impact on the achievement of daily living activities involving hand/arm function. Among several technology-based rehabilitative approaches, Brain-Computer Interfaces (BCIs) which enable the modulation of electroencephalographic sensorimotor rhythms, are promising tools to promote the recovery of hand function after SCI. The "DiSCIoser" study proposes a BCI-supported motor imagery (MI) training to engage the sensorimotor system and thus facilitate the neuroplasticity to eventually optimize upper limb sensorimotor functional recovery in patients with SCI during the subacute phase, at the peak of brain and spinal plasticity. To this purpose, we have designed a BCI system fully compatible with a clinical setting whose efficacy in improving hand sensorimotor function outcomes in patients with traumatic cervical SCI will be assessed and compared to the hand MI training not supported by BCI. METHODS: This randomized controlled trial will include 30 participants with traumatic cervical SCI in the subacute phase randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and the hand MI training not supported by BCI. Both interventions are delivered (3 weekly sessions; 12 weeks) as add-on to standard rehabilitation care. A multidimensional assessment will be performed at: randomization/pre-intervention and post-intervention. Primary outcome measure is the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory sub-score. Secondary outcome measures include the motor and functional scores of the GRASSP and other clinical, neuropsychological, neurophysiological and neuroimaging measures. DISCUSSION: We expect the BCI-based intervention to promote meaningful cortical sensorimotor plasticity and eventually maximize recovery of arm functions in traumatic cervical subacute SCI. This study will generate a body of knowledge that is fundamental to drive optimization of BCI application in SCI as a top-down therapeutic intervention, thus beyond the canonical use of BCI as assistive tool. TRIAL REGISTRATION: Name of registry: DiSCIoser: improving arm sensorimotor functions after spinal cord injury via brain-computer interface training (DiSCIoser). TRIAL REGISTRATION NUMBER: NCT05637775; registration date on the ClinicalTrial.gov platform: 05-12-2022.

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).

Exploring high-density corticomuscular networks after stroke to enable a hybrid Brain-Computer Interface for hand motor rehabilitation.

BACKGROUND: Brain-Computer Interfaces (BCI) promote upper limb recovery in stroke patients reinforcing motor related brain activity (from electroencephalogaphy, EEG). Hybrid BCIs which include peripheral signals (electromyography, EMG) as control features could be employed to monitor post-stroke motor abnormalities. To ground the use of corticomuscular coherence (CMC) as a hybrid feature for a rehabilitative BCI, we analyzed high-density CMC networks (derived from multiple EEG and EMG channels) and their relation with upper limb motor deficit by comparing data from stroke patients with healthy participants during simple hand tasks. METHODS: EEG (61 sensors) and EMG (8 muscles per arm) were simultaneously recorded from 12 stroke (EXP) and 12 healthy participants (CTRL) during simple hand movements performed with right/left (CTRL) and unaffected/affected hand (EXP, UH/AH). CMC networks were estimated for each movement and their properties were analyzed by means of indices derived ad-hoc from graph theory and compared among groups. RESULTS: Between-group analysis showed that CMC weight of the whole brain network was significantly reduced in patients during AH movements. The network density was increased especially for those connections entailing bilateral non-target muscles. Such reduced muscle-specificity observed in patients was confirmed by muscle degree index (connections per muscle) which indicated a connections' distribution among non-target and contralateral muscles and revealed a higher involvement of proximal muscles in patients. CMC network properties correlated with upper-limb motor impairment as assessed by Fugl-Meyer Assessment and Manual Muscle Test in patients. CONCLUSIONS: High-density CMC networks can capture motor abnormalities in stroke patients during simple hand movements. Correlations with upper limb motor impairment support their use in a BCI-based rehabilitative approach.

Overground robotic training effects on walking and secondary health conditions in individuals with spinal cord injury: systematic review.

Overground powered lower limb exoskeletons (EXOs) have proven to be valid devices in gait rehabilitation in individuals with spinal cord injury (SCI). Although several articles have reported the effects of EXOs in these individuals, the few reviews available focused on specific domains, mainly walking. The aim of this systematic review is to provide a general overview of the effects of commercial EXOs (i.e. not EXOs used in military and industry applications) for medical purposes in individuals with SCI. This systematic review was conducted following the PRISMA guidelines and it referred to MED-LINE, EMBASE, SCOPUS, Web of Science and Cochrane library databases. The studies included were Randomized Clinical Trials (RCTs) and non-RCT based on EXOs intervention on individuals with SCI. Out of 1296 studies screened, 41 met inclusion criteria. Among all the EXO studies, the Ekso device was the most discussed, followed by ReWalk, Indego, HAL and Rex devices. Since 14 different domains were considered, the outcome measures were heterogeneous. The most investigated domain was walking, followed by cardiorespiratory/metabolic responses, spasticity, balance, quality of life, human-robot interaction, robot data, bowel functionality, strength, daily living activity, neurophysiology, sensory function, bladder functionality and body composition/bone density domains. There were no reports of negative effects due to EXOs trainings and most of the significant positive effects were noted in the walking domain for Ekso, ReWalk, HAL and Indego devices. Ekso studies reported significant effects due to training in almost all domains, while this was not the case with the Rex device. Not a single study carried out on sensory functions or bladder functionality reached significance for any EXO. It is not possible to draw general conclusions about the effects of EXOs usage due to the lack of high-quality studies as addressed by the Downs and Black tool, the heterogeneity of the outcome measures, of the protocols and of the SCI epidemiological/neurological features. However, the strengths and weaknesses of EXOs are starting to be defined, even considering the different types of adverse events that EXO training brought about. EXO training showed to bring significant improvements over time, but whether its effectiveness is greater or less than conventional therapy or other treatments is still mostly unknown. High-quality RCTs are necessary to better define the pros and cons of the EXOs available today. Studies of this kind could help clinicians to better choose the appropriate training for individuals with SCI.

The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a study protocol for a randomized controlled trial to test early and long-term efficacy and to identify determinants of response.

BACKGROUND: Stroke is a leading cause of long-term disability. Cost-effective post-stroke rehabilitation programs for upper limb are critically needed. Brain-Computer Interfaces (BCIs) which enable the modulation of Electroencephalography (EEG) sensorimotor rhythms are promising tools to promote post-stroke recovery of upper limb motor function. The "Promotoer" study intends to boost the application of the EEG-based BCIs in clinical practice providing evidence for a short/long-term efficacy in enhancing post-stroke hand functional motor recovery and quantifiable indices of the participants response to a BCI-based intervention. To these aims, a longitudinal study will be performed in which subacute stroke participants will undergo a hand motor imagery (MI) training assisted by the Promotoer system, an EEG-based BCI system fully compliant with rehabilitation requirements. METHODS: This longitudinal 2-arm randomized controlled superiority trial will include 48 first ever, unilateral, subacute stroke participants, randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and a hand MI training not supported by BCI. Both interventions are delivered (3 weekly session; 6 weeks) as add-on regimen to standard intensive rehabilitation. A multidimensional assessment will be performed at: randomization/pre-intervention, 48 h post-intervention, and at 1, 3 and 6 month/s after end of intervention. Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention. Secondary outcome measures include: the upper extremity FMA at follow-up, the Modified Ashworth Scale, the Numeric Rating Scale for pain, the Action Research Arm Test, the National Institute of Health Stroke Scale, the Manual Muscle Test, all collected at the different timepoints as well as neurophysiological and neuroimaging measures. DISCUSSION: We expect the BCI-based rewarding of hand MI practice to promote long-lasting retention of the early induced improvement in hand motor outcome and also, this clinical improvement to be sustained by a long-lasting neuroplasticity changes harnessed by the BCI-based intervention. Furthermore, the longitudinal multidimensional assessment will address the selection of those stroke participants who best benefit of a BCI-assisted therapy, consistently advancing the transfer of BCIs to a best clinical practice. TRIAL REGISTRATION: Name of registry: BCI-assisted MI Intervention in Subacute Stroke (Promotoer). TRIAL REGISTRATION NUMBER: NCT04353297 ; registration date on the ClinicalTrial.gov platform: April, 15/2020.

Influences of the biofeedback content on robotic post-stroke gait rehabilitation: electromyographic vs joint torque biofeedback.

BACKGROUND: Add-on robot-mediated therapy has proven to be more effective than conventional therapy alone in post-stroke gait rehabilitation. Such robot-mediated interventions routinely use also visual biofeedback tools. A better understanding of biofeedback content effects when used for robotic locomotor training may improve the rehabilitation process and outcomes. METHODS: This randomized cross-over pilot trial aimed to address the possible impact of different biofeedback contents on patients' performance and experience during Lokomat training, by comparing a novel biofeedback based on online biological electromyographic information (EMGb) versus the commercial joint torque biofeedback (Rb) in sub-acute non ambulatory patients. 12 patients were randomized into two treatment groups, A and B, based on two different biofeedback training. For both groups, study protocol consisted of 12 Lokomat sessions, 6 for each biofeedback condition, 40 min each, 3 sessions per week of frequency. All patients performed Lokomat trainings as an add-on therapy to the conventional one that was the same for both groups and consisted of 40 min per day, 5 days per week. The primary outcome was the Modified Ashworth Spasticity Scale, and secondary outcomes included clinical, neurological, mechanical, and personal experience variables collected before and after each biofeedback training. RESULTS: Lokomat training significantly improved gait/daily living activity independence and trunk control, nevertheless, different effects due to biofeedback content were remarked. EMGb was more effective to reduce spasticity and improve muscle force at the ankle, knee and hip joints. Robot data suggest that Rb induces more adaptation to robotic movements than EMGb. Furthermore, Rb was perceived less demanding than EMGb, even though patient motivation was higher for EMGb. Robot was perceived to be effective, easy to use, reliable and safe: acceptability was rated as very high by all patients. CONCLUSIONS: Specific effects can be related to biofeedback content: when muscular-based information is used, a more direct effect on lower limb spasticity and muscle activity is evidenced. In a similar manner, when biofeedback treatment is based on joint torque data, a higher patient compliance effect in terms of force exerted is achieved. Subjects who underwent EMGb seemed to be more motivated than those treated with Rb.

Outpatient Satisfaction With Osteopathic Manipulative Treatment in a Hospital Center: A Survey.

Context: Although osteopathy is not yet certified as a health profession in Italy, many people choose osteopathic manipulative treatment (OMT) for pain relief. Nevertheless, no study evaluating patients' degree of satisfaction after OMT and the perceived quality of the treatment has occurred in Italy. Objectives: The study intended to assess outpatients' satisfaction with OMT carried out at a hospital. Design: The research team conducted a survey from January 2015 to January 2016 using 3 questionnaires. Setting: The study took place the Fondazione Santa Lucia Hospital (Rome, Italy), an institute for research and health care. Participants: Participants were 101 patients with musculoskeletal (MSK) disorders undergoing OMT at the hospital. Interventions: The OMT was performed by 3 osteopathic practitioners who had completed the 6-y, part-time training program recognized by the Italian Register of Osteopaths. Outcome Measures: To measure the level of their satisfaction, the research team had patients complete the modified patient satisfaction questionnaire (mPSQ), the patient satisfaction with outpatient physical therapy (PSOPT) instrument, and the visual analog scale for satisfaction (VASS). Parametric and nonparametric analyses were performed to correlate the questionnaires and the demographic variables using the Pearson and Spearman tests. Results: Data were obtained from 97 patients, with mean age of 42.48 ± 16.1 y, 50 of whom were female. The data showed high, average general satisfaction after OMT: (1) VASS-9.36 ± 1.00 and (2) PSOPT-43.27 ± 3.65. A significant negative correlation was found between access to care (D1-TOT) on the mPSQ and at ages older than 65 y-r = -0.24 and P < .05. A significant positive correlation was found between the VASS and female gender-r = 0.23 and P < .05. A significant positive correlation was also found between continuity of care (D3-TOT) and continuity of care-family (D3-1) on the mPSQ and education level-r = .20 and P < .05 and r = 0.24, P < .05, respectively, and with other dimensions explored by the questionnaires. Conclusions: The data show a high level of general satisfaction in patients with MSK disorders who underwent OMT in an Italian hospital setting. The overall satisfaction rate was mainly influenced by the patient's perception of the practitioner's technical quality, the continuity of the treatment, and the cost of the service. Some differences emerged for age, gender, and educational level. The information from the current study may be useful for improving the therapeutic assistance provided with OMT and to promote alternative therapies in health and medicine.

Reliability, validity, and effectiveness of center of pressure parameters in assessing stabilometric platform in subjects with incomplete spinal cord injury: a serial cross-sectional study.

BACKGROUND: Spinal cord injury (SCI) can damage long tracts, affecting postural stability. Impairments in balance have recently been proposed to be highly predictive of functional recovery in patients with SCI and thus merit evaluation. In addition to common observational clinical scales, more objective evaluation methods of balance can be implemented by analyzing center of pressure (COP) parameters using stabilometric platforms (SPs). COP analysis has been used in various pathologies, but the COP parameters with regard to measurement vary, depending on the features of the target population, and have only been assessed in healthy subjects. Specifically, concerning subjects with SCI, few studies have reported COP parameters, and none has addressed the reliability, validity, or responsiveness of this measure. The objective of this serial cross-sectional study was to analyze the reliability, validity, and responsiveness of COP parameters under various conditions in incomplete SCI subjects to assess balance. METHODS: Twenty-three patients with incomplete SCI were examined 111 times for 1 year. Each session comprised administration of the Berg Balance scale, Tinetti scale, and WISCI scale and evaluation of stabilometric platform use. Stabilometry was performed under various sensory conditions (OF: open feet; CF: closed feet; OE: open eyes; CE: closed eyes), wherein several COP parameters were analyzed (L: COP path length; V: mean COP velocity, VAP: anteroposterior COP velocity; VLL: laterolateral COP velocity, A: COP ellipse area, SA1: x-axis of COP ellipse area; SA2: y-axis of COP ellipse area). The reliability, validity, and responsiveness of COP parameters that were associated with visual/support area conditions were analyzed. RESULTS: Of the COP parameters, V and arithmetically related measures had the highest reliability, validity, and effectiveness scores. Of all test conditions, OE-OF was the most valid, whereas CE-OF was the most responsive. CONCLUSION: The assessment of balance in SCI subjects can be reliable, valid, and effective in acquiring V data, based on OF-OE and OF-CE conditions and heel distance values.

Harnessing Artificial Neural Networks for Spinal Cord Injury Prognosis.

Background: Prediction of neurorehabilitation outcomes after a Spinal Cord Injury (SCI) is crucial for healthcare resource management and improving prognosis and rehabilitation strategies. Artificial neural networks (ANNs) have emerged as a promising alternative to conventional statistical approaches for identifying complex prognostic factors in SCI patients. Materials: a database of 1256 SCI patients admitted for rehabilitation was analyzed. Clinical and demographic data and SCI characteristics were used to predict functional outcomes using both ANN and linear regression models. The former was structured with input, hidden, and output layers, while the linear regression identified significant variables affecting outcomes. Both approaches aimed to evaluate and compare their accuracy for rehabilitation outcomes measured by the Spinal Cord Independence Measure (SCIM) score. Results: Both ANN and linear regression models identified key predictors of functional outcomes, such as age, injury level, and initial SCIM scores (correlation with actual outcome: R = 0.75 and 0.73, respectively). When also alimented with parameters recorded during hospitalization, the ANN highlighted the importance of these additional factors, like motor completeness and complications during hospitalization, showing an improvement in its accuracy (R = 0.87). Conclusions: ANN seemed to be not widely superior to classical statistics in general, but, taking into account complex and non-linear relationships among variables, emphasized the impact of complications during the hospitalization on recovery, particularly respiratory issues, deep vein thrombosis, and urological complications. These results suggested that the management of complications is crucial for improving functional recovery in SCI patients.

Quantifying Treatments as Usual and with Technologies in Neurorehabilitation of Individuals with Spinal Cord Injury.

Several technologies have been introduced into neurorehabilitation programs to enhance traditional treatment of individuals with Spinal Cord Injury (SCI). Their effectiveness has been widely investigated, but their adoption has not been properly quantified. The aim of this study is to assess the distribution of conventional (Treatment As Usual-TAU) and technology-aided (Treatment With Technologies-TWT) treatments conveniently grouped based on different therapeutic goals in a selected SCI unit. Data from 104 individuals collected in 29 months were collected in a custom database and categorized according to both the conventional American Impairment Scale classification and a newly developed Multifactor (MF) clustering approach that considers additional sources of information (the lesion level, the level of independence in the activities of daily living, and the hospitalization duration). Results indicated an average technology adoption of about 30%. Moreover, the MF clusters were less overlapped, and the differences in TWT adoption were more pronounced than in AIS-based clustering. MF clustering was capable of grouping individuals based both on neurological features and functional abilities. In particular, individuals with motor complete injuries were grouped together, whereas individuals with sensorimotor incomplete SCI were collected separately based on the lesion level. As regards TWT adoption, we found that in the case of motor complete SCI, TWT for muscle tone control and modulation was mainly selected (about 90% of TWT), while the other types of TWT were seldom adopted. Even for individuals with incomplete SCI, the most frequent rehabilitation goal was muscle tone modulation (about 75% of TWT), regardless of the AIS level, and technologies to improve walking ability (about 12% of TWT) and balance control (about 10% of TWT) were mainly used for individuals with thoracic or lumbar lesions. Analyzing TAU distribution, we found that the highest adoption of muscle tone modulation strategies was reported in the case of individuals with motor complete SCI (about 42% of TAU), that is, in cases when almost no gait training was pursued (about 1% of TAU). In the case of cervical motor incomplete SCI, compared to thoracic and lumbar incomplete SCI, there was a greater focus on muscle tone control and force recruitment in addition to walking training (38% and 14% of TAU, respectively) than on balance training. Overall, the MF clustering provided more insights than the traditional AIS-based classification, highlighting differences in TWT adoption. These findings suggest that a wider overview that considers both neurological and functional characteristics of individuals after SCI based on a multifactor analysis could enhance the personalization of neurorehabilitation strategies.

Unveiling the mosaic: comparing demographics and outcomes in traumatic vs. non-traumatic spinal cord injuries.

BACKGROUND: This study analyzed the percentage of patients with nontraumatic spinal cord injury (SCI) which is increasing with the increase of population age. However, little is known about the effect of the etiology of SCI on the outcome of these subjects. AIM: The aim of this study was to investigate functional and neurological outcomes in patients with traumatic and nontraumatic spinal cord lesions, with a focus on factors influencing rehabilitation outcomes. DESIGN: The design of this study was that of a retrospective analysis of prospectively recorded data. SETTING: The setting of this analysis was a single Spinal Unit in Italy. POPULATION: The population included 1080 subjects, of which 599 (55%) had injuries of traumatic origin and 481 (45%) had nontraumatic injuries. METHODS: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Spinal Cord Independence Measure (SCIM) and the Walking Index for Spinal Cord Injury (WISCI) were utilized as measurement tools. Multivariate (backwards selection, P=0.20) logistic regression was used to assess the associations of "complication during hospitalization," "bowel management autonomy," "spontaneous micturition," "home destination" and "neurological improvement" with the following variables: etiology, age, sex, lesion level and severity and length of stay. Multivariate (backwards selection, P=0.20) negative binomial regression was used to assess the relative risks of higher SCIM and WISCI Scores at discharge after adjusting for the abovementioned variables. RESULTS: Our work highlighted several significant differences between the traumatic and nontraumatic groups (including age, sex, lesion severity, and time from lesion onset to admission). Both groups exhibited comparable improvements in neurological and functional status, although some data were in favor of subjects with traumatic lesions. However, the regression analyses demonstrated that the main factors impacting the neurological and functional status at discharge were age, lesion level and severity, rather than the etiology of the lesion. CONCLUSIONS: Our study provides valuable insights into the rehabilitation trajectories of traumatic and nontraumatic spinal cord injuries and demonstrates that the cause of SCI has no impact on rehabilitation outcomes. CLINICAL REHABILITATION IMPACT: An understanding of neurological and functional recovery after spinal cord lesions is essential for answering patients' questions about their potential functional capabilities. It also assists in determining the necessary resources for inpatient rehabilitation and post discharge care. Moreover, the possession of a thorough grasp of the course and factors influencing the natural recovery of a spinal cord lesion is now a scientific necessity and is crucial for assessing the efficacy of new pharmacological and rehabilitative methods.

Robotic versus Conventional Overground Gait Training in Subacute Stroke Survivors: A Multicenter Controlled Clinical Trial.

BACKGROUND: Although stroke survivors can benefit from robotic gait rehabilitation, stationary robot-assisted gait training needs further investigation. In this paper, we investigated the efficacy of this approach (with an exoskeleton or an end-effector robot) in comparison to the conventional overground gait training in subacute stroke survivors. METHODS: In a multicenter controlled clinical trial, 89 subacute stroke survivors conducted twenty sessions of robot-assisted gait training (Robotic Group) or overground gait training (Control Group) in addition to the standard daily therapy. The robotic training was performed with an exoskeleton (RobotEXO-group) or an end-effector (RobotEND-group). Clinical outcomes were assessed before (T0) and after (T1) the treatment. The walking speed during the 10-Meter Walk Test (10 MWT) was the primary outcome of this study, and secondary outcomes were the 6-Minute Walk Test (6 MWT), Timed Up and Go test (TUG), and the modified Barthel Index (mBI). RESULTS: The main characteristics assessed in the Robotic and Control groups did not differ at baseline. A significant benefit was detected from the 10 MWT in the Robotic Group at the end of the study period (primary endpoint). A benefit was also observed from the following parameters: 6 MWT, TUG, and mBI. Moreover, patients belonging to the Robot Group outperformed the Control Group in gait speed, endurance, balance, and ADL. The RobotEND-group improved their walking speed more than the RobotEXO-group. CONCLUSION: The stationary robot-assisted training improved walking ability better than the conventional training in subacute stroke survivors. These results suggest that people with subacute stroke may benefit from Robot-Assisted training in potentiating gait speed and endurance. Our results also support that end-effector robots would be superior to exoskeleton robots for improving gait speed enhancement.

The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a statistical analysis plan for a randomized controlled trial.

BACKGROUND: Electroencephalography (EEG)-based brain-computer interfaces (BCIs) allow to modulate the sensorimotor rhythms and are emerging technologies for promoting post-stroke motor function recovery. The Promotoer study aims to assess the short and long-term efficacy of the Promotoer system, an EEG-based BCI assisting motor imagery (MI) practice, in enhancing post-stroke functional hand motor recovery. This paper details the statistical analysis plan of the Promotoer study. METHODS: The Promotoer study is a randomized, controlled, assessor-blinded, single-centre, superiority trial, with two parallel groups and a 1:1 allocation ratio. Subacute stroke patients are randomized to EEG-based BCI-assisted MI training or to MI training alone (i.e. no BCI). An internal pilot study for sample size re-assessment is planned. The primary outcome is the effectiveness of the Upper Extremity Fugl-Meyer Assessment (UE-FMA) score. Secondary outcomes include clinical, functional, and user experience scores assessed at the end of intervention and at follow-up. Neurophysiological assessments are also planned. Effectiveness formulas have been specified, and intention-to-treat and per-protocol populations have been defined. Statistical methods for comparisons of groups and for development of a predictive score of significant improvement are described. Explorative subgroup analyses and methodology to handle missing data are considered. DISCUSSION: The Promotoer study will provide robust evidence for the short/long-term efficacy of the Promotoer system in subacute stroke patients undergoing a rehabilitation program. Moreover, the development of a predictive score of response will allow transferring of the Promotoer system to optimal clinical practice. By carefully describing the statistical principles and procedures, the statistical analysis plan provides transparency in the analysis of data. TRIAL REGISTRATION: ClinicalTrials.gov NCT04353297 . Registered on April 15, 2020.

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).

Efficacy of Overground Robotic Gait Training on Balance in Stroke Survivors: A Systematic Review and Meta-Analysis.

Strokes often lead to a deficit in motor control that contributes to a reduced balance function. Impairments in the balance function severely limit the activities of daily living (ADL) in stroke survivors. The present systematic review and meta-analysis primarily aims to explore the efficacy of overground robot-assisted gait training (o-RAGT) on balance recovery in individuals with stroke. In addition, the efficacy on ADL is also investigated. This systematic review identified nine articles investigating the effects of o-RAGT on balance, four of which also assessed ADL. The results of the meta-analysis suggest that o-RAGT does not increase balance and ADL outcomes more than conventional therapy in individuals after stroke. The data should not be overestimated due to the low number of studies included in the meta-analysis and the wide confidence intervals. Subgroup analyses to investigate the influence of participant's characteristics and training dosage were not performed due to lack of data availability. Further well-designed randomized controlled trials are needed to investigate the efficacy of o-RAGT on balance in individuals with stroke.

Technology-assisted balance assessment and rehabilitation in individuals with spinal cord injury: A systematic review.

BACKGROUND: Balance is a crucial function of basic Activities of Daily Living (ADL) and is often considered the priority in Spinal Cord Injury (SCI) patients' rehabilitation. Technological devices have been developed to support balance assessment and training, ensuring an earlier, intensive, and goal-oriented motor therapy. OBJECTIVE: The aim of this systematic review is to explore the technology-assisted strategies to assess and rehabilitate balance function in persons with SCI. METHODS: A systematic review was conducted in the databases PubMed, Scopus, IEEE Xplore, Cochrane Library, and Embase. Full reports on Randomized Clinical Trials (RCTs) of parallel-group or cross-over design and non-RCTs were included according to the following criteria: i) publication year from 1990 to 2021; ii) balance considered as a primary or secondary outcome; iii) population of individuals with SCI with age over 18 years old, regardless of traumatic or non-traumatic lesions, Time Since Injury, lesion level, Asia Impairment Scale score and gender. The methodological quality was determined for each included study according to the recognized Downs and Black (D&B) tool. RESULTS: Nineteen articles met the inclusion criteria and were included in the analysis. Four articles focused on balance assessment while 15 targeted rehabilitation interventions to improve balance by using Treadmill-Based Devices (TBD), OverGround Devices (OGD) and Tilt Table Devices (TTD). Statistically significant effects on balance can be found in TBD subcategory, in the hip-knee guidance subcategory of OGD and in the study of TTD category. CONCLUSION: Although different studies reported positive effects, improvements due to technology-assisted rehabilitation were not greater than those obtained by means of other rehabilitation therapies. The heterogeneity, low methodological quality, and the small number of the studies included do not allow general conclusions about the usefulness of technology-assisted balance assessment and training in individuals with SCI, even if significant improvements have been reported in some studies.

Neurogenic Bowel Dysfunction Changes after Osteopathic Care in Individuals with Spinal Cord Injuries: A Preliminary Randomized Controlled Trial.

BACKGROUND: Neurogenic bowel dysfunction (NBD) indicates bowel dysfunction due to a lack of nervous control after a central nervous system lesion. Bowel symptoms, such as difficulties with evacuation, constipation, abdominal pain and swelling, are experienced commonly among individuals with spinal cord injury (SCI). Consequentially, individuals with SCI experience a general dissatisfaction with the lower perceived quality of life (QoL). Several studies have demonstrated the positive effects of manual therapies on NBD, including Osteopathic Manipulative Treatment (OMT). This study aimed to explore OMT effects on NBD in individuals with SCI compared with Manual Placebo Treatment (MPT). METHODS: The study was a double-blind randomized controlled trial composed of three phases, each one lasting 30 days (i: NBD/drugs monitoring; ii: four OMT/MPT sessions; iii: NBD/drug monitoring and follow-up evaluation). RESULTS: the NBD scale, the QoL on worries and concerns sub-questionnaire, and the perception of abdominal swelling and constipation significantly improved after treatments compared to baseline only for individuals who underwent OMT. CONCLUSION: These preliminary results showed positive effects of OMT on bowel function and QoL in individuals with SCI, but further studies are needed to confirm our results.

Manual Physiotherapy Combined with Pelvic Floor Training in Women Suffering from Stress Urinary Incontinence and Chronic Nonspecific Low Back Pain: A Preliminary Study.

Stress urinary incontinence (SUI) represents one of the most common subtypes of urinary incontinence (UI) reported by women. Studies have shown an association of SUI with nonspecific low back pain (NSLBP). The primary aim of the present study was to explore the long-term effects of a combined treatment of manual techniques and pelvic floor muscle (PFM) training in women suffering from SUI associated with NSLBP. The secondary aim was to evaluate which manual approach combined with PFM rehabilitation is more effective in improving symptoms related to SUI and in reducing pain perception related to NSLBP. Twenty-six patients suffering from SUI associated with chronic NSLBP were randomly assigned to one of two groups: the postural rehabilitation group (PRg) or the spinal mobilization group (SMg). Both groups performed a manual approach combined with PFM rehabilitation. All patients were evaluated before the treatment (T0), after 10 sessions (T1) and after 30 days from the end of the treatment (T2). The results showed an improvement in both groups in all of the investigated outcomes. Combining manual therapy and PFM training within the same therapy session may be useful for improving both SUI and NSLBP and increasing the quality of life of women suffering from SUI associated with NSLBP.

Rehabilitation of gait after stroke: a review towards a top-down approach.

This document provides a review of the techniques and therapies used in gait rehabilitation after stroke. It also examines the possible benefits of including assistive robotic devices and brain-computer interfaces in this field, according to a top-down approach, in which rehabilitation is driven by neural plasticity.The methods reviewed comprise classical gait rehabilitation techniques (neurophysiological and motor learning approaches), functional electrical stimulation (FES), robotic devices, and brain-computer interfaces (BCI).From the analysis of these approaches, we can draw the following conclusions. Regarding classical rehabilitation techniques, there is insufficient evidence to state that a particular approach is more effective in promoting gait recovery than other. Combination of different rehabilitation strategies seems to be more effective than over-ground gait training alone. Robotic devices need further research to show their suitability for walking training and their effects on over-ground gait. The use of FES combined with different walking retraining strategies has shown to result in improvements in hemiplegic gait. Reports on non-invasive BCIs for stroke recovery are limited to the rehabilitation of upper limbs; however, some works suggest that there might be a common mechanism which influences upper and lower limb recovery simultaneously, independently of the limb chosen for the rehabilitation therapy. Functional near infrared spectroscopy (fNIRS) enables researchers to detect signals from specific regions of the cortex during performance of motor activities for the development of future BCIs. Future research would make possible to analyze the impact of rehabilitation on brain plasticity, in order to adapt treatment resources to meet the needs of each patient and to optimize the recovery process.