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.

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.

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.

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.

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.

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.

Load Auditory Feedback Boosts Crutch Usage in Subjects With Central Nervous System Lesions: A Pilot Study.

Background: Crutches are the most common walking aids prescribed to improve mobility in subjects with central nervous system (CNS) lesions. To increase adherence to the appropriate level of crutch usage, providing load-related auditory feedback (aFB) may be a useful approach. We sensorized forearm crutches and developed a custom software to provide aFB information to both user and physical therapist (PhT). Aim: Evaluate aFB effects on load control during gait by a self-controlled case series trial. Methods: A single experimental session was conducted enrolling 12 CNS lesioned participants. Load on crutch was recorded during 10 Meter Walk Test performed with and without aFB. In both cases, crutch load data, and gait speed were recorded. Usability and satisfaction questionnaires were administered to participants and PhTs involved. Results: Reliable data were obtained from eight participants. Results showed that compared to the no FB condition, aFB yielded a significant reduction in the mean load on the crutches during gait (p = 0.001). The FB did not influence gait speed or fatigue (p > 0.05). The experience questionnaire data indicated a positive experience regarding the use of aFB from both participants' and PhTs' perspectives. Conclusion: aFB significantly improves compliance with crutch use and does not affect gait speed or fatigue by improving the load placed on crutches. The FB is perceived by users as helpful, safe, and easy to learn, and does not interfere with attention or concentration while walking. Furthermore, the PhTs consider the system to be useful, easy to learn and reliable.

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.