Reliability Validity and Responsiveness of the Spinal Cord Independence Measure 4th Version in a Multicultural Setup.

OBJECTIVE: To examine the fourth version of the Spinal Cord Independence Measure for reliability and validity. DESIGN: Partly blinded comparison with the criterion standard Spinal Cord Independence Measure III, and between examiners and examinations. SETTING: A multicultural cohort from 19 spinal cord injury units in 11 countries. PARTICIPANTS: A total of 648 patients with spinal cord injury. INTERVENTION: Assessment with Spinal Cord Independence Measure (SCIM IV) and Spinal Cord Independence Measure (SCIM III) on admission to inpatient rehabilitation and before discharge. MAIN OUTCOME MEASURES: SCIM IV interrater reliability, internal consistency, correlation with and difference from SCIM III, and responsiveness. RESULTS: Total agreement between examiners was above 80% on most SCIM IV tasks. All Kappa coefficients were above 0.70 and statistically significant (P<.001). Pearson's coefficients of the correlation between the examiners were above 0.90, and intraclass correlation coefficients were above 0.90. Cronbach's alpha was above 0.96 for the entire SCIM IV, above 0.66 for the subscales, and usually decreased when an item was eliminated. Reliability values were lower for the subscale of respiration and sphincter management, and on admission than at discharge. SCIM IV and SCIM III mean values were very close, and the coefficients of Pearson correlation between them were 0.91-0.96 (P<.001). The responsiveness of SCIM IV was not significantly different from that of SCIM III in most of the comparisons. CONCLUSIONS: The validity, reliability, and responsiveness of SCIM IV, which was adjusted to assess specific patient conditions or situations that SCIM III does not address, and which includes more accurate definitions of certain scoring criteria, are very good and quite similar to those of SCIM III. SCIM IV can be used for clinical and research trials, including international multi-center studies, and its group scores can be compared with those of SCIM III.

Structural and functional left ventricular impairment in subjects with chronic spinal cord injury and no overt cardiovascular disease.

CONTEXT: Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in subjects with long-term spinal cord injury (SCI). More specific recommendations for CVD prevention in this population are needed. METHODS: One hundred thirty male subjects (47 subjects with SCI and 83 able-bodied persons (ABPs), mean age 43.89 ± 1.9 and 45.44 ± 12.2 years; P = 0.48) underwent transthoracic echocardiography (TTE). The effects of age, weight, mean arterial pressure (MAP) and level of physical training on cardiac adaptations were evaluated through multiple regression analysis. RESULTS: In subjects with SCI, TTE revealed increased wall thickness (P < 0.05), lower E wave, E/A ratio and early diastolic myocardial relaxation velocity on Tissue Doppler Imaging (TDI) (P < 0.05) and higher systolic myocardial contraction velocity on TDI (0.10 ± 0.02 vs. 0.09 ± 0.02 m/seconds, P = 0.002) and peak systolic pressure to end-systolic volume ratio (3.62 ± 1.39 vs. 2.82 ± 0.90, P < 0.001) compared with ABPs. Aortic diameters were larger in subjects with SCI than ABPs. Differences remained statistically significant even after adjustment for age, weight, MAP, and level of physical training. Weight and age were found to be independent variables that substantially affected left ventricular structure and function in subjects with SCI. CONCLUSIONS: Subjects with post-traumatic chronic SCI and no overt cardiovascular risk factors, exhibit initial left ventricular remodeling (as assessed by TTE) compared with ABPs. Lifestyle modifications, including regular physical exercise and weight control, should be implemented in all subjects with SCI, even at a very early stage, in order to reduce cardiovascular risk and prevent the development of CVD.

The net contribution of rehabilitation to improvement in performance in patients with spinal cord lesions in five countries.

CONTEXT: Change in ability realization reflects the main contribution of rehabilitation to improvement in the performance of daily activities in patients with spinal cord lesions (SCL). OBJECTIVE: To assess the net effect of rehabilitation of patients with SCL and compare it between countries. METHODS: We calculated the Spinal Cord Ability Realization Measurement Index (SCI-ARMI) and its change from admission to rehabilitation to discharge, for inpatients admitted to SCL units in five countries, between 2016 and 2019. We used chi-square tests, analysis of variance (ANOVA), McNemar's test, Pearson's correlations, and analysis of covariance (ANCOVA) to compare countries and patient groups and assess the relationships of various factors with SCI-ARMI gain during rehabilitation. RESULTS: The study included 218 inpatients (67% males, age 52 ± 17). In Brazil, Israel, Italy, Portugal, and Turkiye, respectively, SCI-ARMI gain was 2 (SD = 15), 19 (SD = 17), 31 (SD = 23), 13 (SD = 15), and 16 (SD = 12). Yet, after controlling for admission SCI-ARMI and the time from SCL onset to the examination, the effect of the country on ability realization gain was found non-significant (P = 0.086). CONCLUSION: The study confirmed that rehabilitation makes a net contribution to improvement in performance in patients with SCL, beyond the contribution of neurological recovery. After controlling for affecting factors, this contribution was quite similar in the participating units from different countries.

A multi-center international study on the spinal cord independence measure, version IV: Rasch psychometric validation.

CONTEXT: The Spinal Cord Independence Measure is a comprehensive functional rating scale for individuals with spinal cord lesion (SCL). OBJECTIVE: To validate the scores of the three subscales of SCIM IV, the fourth version of SCIM, using advanced statistical methods. STUDY DESIGN: Multi-center cohort study. SETTING: Nineteen SCL units in 11 countries. METHODS: SCIM developers created SCIM IV following comments by experts, included more accurate definitions of scoring criteria in the SCIM IV form, and adjusted it to assess specific conditions or situations that the third version, SCIM III, does not address. Professional staff members assessed 648 SCL inpatients, using SCIM IV and SCIM III, at admission to rehabilitation, and at discharge. The authors examined the validity and reliability of SCIM IV subscale scores using Rasch analysis. RESULTS: The study included inpatients aged 16-87 years old. SCIM IV subscale scores fit the Rasch model. All item infit and most item outfit mean-square indices were below 1.4; statistically distinct strata of abilities were 2.6-6; most categories were properly ordered; item hierarchy was stable across most clinical subgroups and countries. In a few items, however, we found misfit or category threshold disordering. We found SCIM III and SCIM IV Rasch properties to be comparable. CONCLUSIONS: Rasch analysis suggests that the scores of each SCIM IV subscale are reliable and valid. This reinforces the justification for using SCIM IV in clinical practice and research.

A mobile app for home-based exercise in spinal cord injured persons: Proposal and pilot study.

BACKGROUND AND OBJECTIVE: To preserve cardiovascular health in persons with spinal cord injury (SCI), it is important to promote physical activity programs adapted to them. Home-based exercise programs allow patients to perform clinician-prescribed physical activity without going to a hospital. However, they make it difficult for the clinician to guide and monitor the patient. To face this issue, this paper proposes a novel smartphone-based mobile application (Fisiofriend), and evaluates its feasibility with a pilot study in a real clinical intervention. METHODS: Fourteen SCI male subjects were involved in a 6-weeks home-based intervention, based on upper limbs exercises: 7 subjects (APP group) used Fisiofriend, and 7 subjects used traditional pictorial instructions on paper (PAPER group). At the beginning (t1) and end (t2) of the study period, we measured: (i) biceps and triceps brachii strength and endurance parameters with an isokinetic dynamometer (Biodex System 4), (ii) O2 maximal consumption with a crank ergometer stress test (VO2000, Medgraphics). Moreover, we collected subjective data about subjects' perception of the support (app or paper) in the home-based program. RESULTS: Physiological results were encouraging for both groups. Questionnaire data suggests a possible advantage of the app in terms of pleasantness, engagement and perception of positive effects. Practical clinical experience with the subjects and their informal reports highlighted which features of the app could be of particular benefit in real interventions, as we discuss in the paper. CONCLUSIONS: The study showed the feasibility of using a mobile app in home-based exercise programs involving SCI patients. We discuss implications of introducing such kind of apps into clinical practice.

Robot-assisted gait training in patients with Parkinson's disease: Implications for clinical practice. A systematic review.

BACKGROUND: Gait impairments are common disabling symptoms of Parkinson's disease (PD). Among the approaches for gait rehabilitation, interest in robotic devices has grown in recent years. However, the effectiveness compared to other interventions, the optimum amount of training, the type of device, and which patients might benefit most remains unclear. OBJECTIVE: To conduct a systematic review about the effects on gait of robot-assisted gait training (RAGT) in PD patients and to provide advice for clinical practice. METHODS: A search was performed on PubMed, Scopus, PEDro, Cochrane library, Web of science, and guideline databases, following PRISMA guidelines. We included English articles if they used a robotic system with details about the intervention, the parameters, and the outcome measures. We evaluated the level and quality of evidence. RESULTS: We included twenty papers out of 230 results: two systematic reviews, 9 randomized controlled trials, 4 uncontrolled studies, and 5 descriptive reports. Nine studies used an exoskeleton device and the remainders end-effector robots, with large variability in terms of subjects' disease-related disability. CONCLUSIONS: RAGT showed benefits on gait and no adverse events were recorded. However, it does not seem superior to other interventions, except in patients with more severe symptoms and advanced disease.

Evidence-based improvement of gait in post-stroke patients following robot-assisted training: A systematic review.

BACKGROUND: The recovery of walking after stroke is a priority goal for recovering autonomy. In the last years robotic systems employed for Robotic Assisted Gait Training (RAGT) were developed. However, literature and clinical practice did not offer standardized RAGT protocol or pattern of evaluation scales. OBJECTIVE: This systematic review aimed to summarize the available evidence on the use of RAGT in post-stroke, following the CICERONE Consensus indications. METHODS: The literature search was conducted on PubMed, Cochrane Library and PEDro, including studies with the following criteria: 1) adult post-stroke survivors with gait disability in acute/subacute/chronic phase; 2) RAGT as intervention; 3) any comparators; 4) outcome regarding impairment, activity, and participation; 5) both primary studies and reviews. RESULTS: Sixty-one articles were selected. Data about characteristics of patients, level of disability, robotic devices used, RAGT protocols, outcome measures, and level of evidence were extracted. CONCLUSION: It is possible to identify robotic devices that are more suitable for specific phase disease and level of disability, but we identified significant variability in dose and protocols. RAGT as an add-on treatment seemed to be prevalent. Further studies are needed to investigate the outcomes achieved as a function of RAGT doses delivered.

What does evidence tell us about the use of gait robotic devices in patients with multiple sclerosis? A comprehensive systematic review on functional outcomes and clinical recommendations.

INTRODUCTION: There is growing evidence on the efficacy of gait robotic rehabilitation in patients with multiple sclerosis (MS), but most of the studies have focused on gait parameters. Moreover, clear indications on the clinical use of robotics still lack. As part of the CICERONE Italian Consensus on Robotic Rehabilitation, the aim of this systematic review was to investigate the existing evidence concerning the role of lower limb robotic rehabilitation in improving functional recovery in patients with MS. EVIDENCE ACQUISITION: We searched for and systematically reviewed evidence-based studies on gait robotic rehabilitation in MS, between January 1st, 2010 and December 31st, 2020, in the following databases: Cochrane Library, PEDro, PubMed and Google Scholar. The study quality was assessed by the 16-item assessment of multiple systematic reviews 2 (AMSTAR 2) and the 10-item PEDro scale for the other research studies. EVIDENCE SYNTHESIS: After an accurate screening, only 17 papers were included in the review, and most of them (13 RCT) had a level II evidence. Most of the studies used the Lokomat as a grounded robotic device, two investigated the efficacy of end-effectors and two powered exoskeletons. Generally speaking, robotic treatment has beneficial effects on gait speed, endurance and balance with comparable outcomes to those of conventional treatments. However, in more severe patients (EDSS >6), robotics leads to better functional outcomes. Notably, after gait training with robotics (especially when coupled to virtual reality) MS patients also reach better non-motor outcomes, including spasticity, fatigue, pain, psychological well-being and quality of life. Unfortunately, no clinical indications emerge on the treatment protocols. CONCLUSIONS: The present comprehensive systematic review highlights the potential beneficial role on functional outcomes of the lower limb robotic devices in people with MS. Future studies are warranted to evaluate the role of robotics not only for walking and balance outcomes, but also for other gait-training-related benefits, to identify appropriate outcome measures related to a specific subgroup of MS subjects' disease severity.

Robotic-assisted gait rehabilitation following stroke: a systematic review of current guidelines and practical clinical recommendations.

INTRODUCTION: Stroke is the third leading cause of adult disability worldwide, and lower extremity motor impairment is one of the major determinants of long-term disability. Although robotic therapy is becoming more and more utilized in research protocols for lower limb stroke rehabilitation, the gap between research evidence and its use in clinical practice is still significant. The aim of this study was to determine the scope, quality, and consistency of guidelines for robotic lower limb rehabilitation after stroke, in order to provide clinical recommendations. EVIDENCE ACQUISITION: We systematically reviewed stroke rehabilitation guideline recommendations between January 1, 2010 and October 31, 2020. We explored electronic databases (N.=4), guideline repositories and professional rehabilitation networks (N.=12). Two independent reviewers used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, and brief syntheses were used to evaluate and compare the different recommendations, considering only the most recent version. EVIDENCE SYNTHESIS: From the 1219 papers screened, ten eligible guidelines were identified from seven different regions/countries. Four of the included guidelines focused on stroke management, the other six on stroke rehabilitation. Robotic rehabilitation is generally recommended to improve lower limb motor function, including gait and strength. Unfortunately, there is still no consensus about the timing, frequency, training session duration and the exact characteristics of subjects who could benefit from robotics. CONCLUSIONS: Our systematic review shows that the introduction of robotic rehabilitation in standard treatment protocols seems to be the future of stroke rehabilitation. However, robot assisted gait training (RAGT) for stroke needs to be improved with new solutions and in clinical practice guidelines, especially in terms of applicability.

Carotid Artery Stiffness and Development of Hypertension in People with Paraplegia and No Overt Cardiovascular Disease: A 7-year Follow-up Study.

OBJECTIVES: The aim of this study was to compare arterial stiffness between people with paraplegia and able-bodied persons (ABPs) and to assess cardiovascular markers that may be predictive of the development of arterial hypertension in people with spinal cord injury (SCI). SETTING: This study was conducted at rehabilitation Hospital, Udine (Italy). METHODS: Fifty-seven patients with SCI were prospectively enrolled and compared with 88 healthy ABPs. All patients underwent comprehensive transthoracic echocardiography, and one-point left common carotid artery (CCA) color-Doppler study for arterial stiffness. RESULTS: Patients with SCI had significantly lower body mass index (BMI) and diastolic blood pressure (BP) compared with ABPs, and significantly higher carotid stiffness values (and lower arterial compliance) (P < 0.05) after adjustment for age, sex, BMI, physical activity, and heart rate. The SCI patients had lower values of the right ventricular function parameters (tricuspid annular plane systolic excursion and right Sm; P < 0.0001), increased wall thickness, and impaired diastolic function. At 7-year follow-up, 10.5% of SCI patients showed high BP; they were significantly heavier with a tendency toward increased abdominal obesity after adjustment for age and systolic BP. BMI was found to be an independent predictor of the development of hypertension. CONCLUSIONS: Patients with posttraumatic chronic SCI and no overt cardiovascular disease exhibit higher CCA stiffness along with the left and right ventricular involvement, compared with ABPs. People with paraplegia who develop arterial hypertension show increased CCA stiffness mediated by obesity. Lifestyle modifications and weight control should be promoted in all patients with SCI, even at a very early stage.

Exercise prescription in subjects with spinal cord injuries.

OBJECTIVE: To evaluate the effect of training with ergometers on subjects with spinal cord injury (SCI) in the postacute phase. DESIGN: Cohort study. SETTING: A spinal unit at a physical medicine and rehabilitation institute. PARTICIPANTS: Twenty-one subjects with SCI in the postacute phase as a consecutive sample were chosen on a strict first-come, first-chosen basis. All patients completed the study. INTERVENTIONS: A 6-week (5d/wk, 90 min/d) program consisting of exercises with the ergometers formulated (as intensity and duration) for each patient on the basis of the results obtained in specific cardiovascular tests. MAIN OUTCOME MEASURES: Parameters of workload levels, as well as hematologic and hormonal parameters, recorded during the first 6 weeks of training. RESULTS: The workload performed during the training showed an initial increase, but it reached a plateau in week 4. No statistically meaningful variations in the workload emerged between the fourth and the sixth weeks of monitoring. There were no hematologic or hormonal signs of overtraining. CONCLUSIONS: Strengthening and aerobic rehabilitation programs for patients with subacute SCI should be limited to 4 weeks, followed by an independent maintenance exercise program. The strengthening program is safe for these patients.