The New Modular Sforzesco Brace (Modular Italian Brace) Is as Effective as the Classical One: A Retrospective Controlled Study from a Prospective Cohort.

Background: The Sforzesco brace is a very rigid push-up brace effective in adolescent idiopathic scoliosis (AIS). We recently developed a new Sforzesco brace based on modularity (the Modular Italian brace-MI brace) that could allow standardization, facilitating global expertise diffusion, increased modifiability and adaptability, and cost savings due to longer brace life. We aimed to compare the short-term results of the two braces. Methods: The retrospective study included 231 consecutive AIS treated with a MI brace (N = 53) or Sforzesco brace (N = 178). The main outcome was the first 6-month follow-up out-of-brace radiograph Cobb angle change. Secondary outcomes included the in-brace Cobb degrees and aesthetics (TRACE), prominence (angle of trunk rotation and mm), kyphosis, and lordosis changes. Results: The two groups were similar at baseline, apart from more immature patients in MI brace. Both braces reduced the Cobb angle (-6° out-of-brace; -16° in-brace) without differences between groups. All secondary outcomes improved, apart from a statistically and clinically insignificant 3° kyphosis reduction. The MI brace participants were 4.9 times more likely to improve the Cobb angle than the Sforzesco brace (OR = 4.92; 95%CI 1.91-12.64; p = 0.001). Conclusions: These findings suggest that the MI-brace can be safely used instead of the classical Sforzesco brace. However, further studies of different designs and longer follow-ups are needed to confirm these findings.

Developing a new tool for scoliosis screening in a tertiary specialistic setting using artificial intelligence: a retrospective study on 10,813 patients: 2023 SOSORT award winner.

PURPOSE: The study aims to assess if the angle of trunk rotation (ATR) in combination with other readily measurable clinical parameters allows for effective non-invasive scoliosis screening. METHODS: We analysed 10,813 patients (4-18 years old) who underwent clinical and radiological evaluation for scoliosis in a tertiary clinic specialised in spinal deformities. We considered as predictors ATR, Prominence (mm), visible asymmetry of the waist, scapulae and shoulders, familiarity, sex, BMI, age, menarche, and localisation of the curve. We implemented a Logistic Regression model to classify the Cobb angle of the major curve according to thresholds of 15, 20, 25, 30, and 40 degrees, by randomly splitting the dataset into 80-20% for training and testing, respectively. RESULTS: The model showed accuracies of 74, 81, 79, 79, and 84% for 15-, 20-, 25-, 30- and 40-degrees thresholds, respectively. For all the thresholds ATR, Prominence, and visible asymmetry of the waist were the top five most important variables for the prediction. Samples that were wrongly classified as negatives had always statistically significant (p ≪ 0.01) lower values of ATR and Prominence. This confirmed that these two parameters were very important for the correct classification of the Cobb angle. The model showed better performances than using the 5 and 7 degrees ATR thresholds to prescribe a radiological examination. CONCLUSIONS: Machine-learning-based classification models have the potential to effectively improve the non-invasive screening for AIS. The results of the study constitute the basis for the development of easy-to-use tools enabling physicians to decide whether to prescribe radiographic imaging.

How do patients sleep after orthopaedic surgery? Changes in objective sleep parameters and pain in hospitalized patients undergoing hip and knee arthroplasty.

PURPOSE: The aim of this observational cohort study was to assess actigraphy-based sleep characteristics and pain scores in patients undergoing knee or hip joint replacement and hospitalized for ten days after surgery. METHODS: N=20 subjects (mean age: 64.0±10.39 years old) wore the Actiwatch 2 actigraph (Philips Respironics, USA) to record sleep parameters for 11 consecutive days. Subjective scores of pain, by a visual analog scale (VAS), were constantly monitored and the following evaluation time points were considered for the analysis: pre-surgery (PRE), the first (POST1), the fourth (POST4), and the tenth day (POST10) after surgery. RESULTS: Sleep quantity and timing parameters did not differ from PRE to POST10, during the hospitalization whereas sleep efficiency and immobility time significantly decreased at POST1 compared to PRE by 10.8% (p=0.003; ES: 0.9, moderate) and 9.4% (p=0.005; ES: 0.86, moderate) respectively, and sleep latency increased by 18.7 min (+320%) at POST1 compared to PRE (p=0.046; ES: 0.70, moderate). Overall, all sleep quality parameters showed a trend of constant improvement from POST1 to POST10. VAS scores were higher in the first day post-surgery (4.58 ± 2.46; p=0.0011 and ES: 1.40, large) compared to POST10 (1.68 ± 1.58). During the time, mean VAS showed significant negative correlations with mean sleep efficiency (r = -0.71; p=0.021). CONCLUSION: Sleep quantity and timing parameters were stable during the entire hospitalization whereas sleep quality parameters significantly worsened the first night after surgery compared to the pre-surgery night. High scores of pain were associated with lower overall sleep quality.

Rehabilitation and COVID-19: systematic review by Cochrane Rehabilitation.

INTRODUCTION: Until the last update in February 2022, the Cochrane Rehabilitation COVID-19 Evidence-based Response (REH-COVER) action identified an increasing volume of evidence for the rehabilitation management of COVID-19. Therefore, our aim was to identify the best available evidence on the effectiveness of interventions for rehabilitation for COVID-19-related limitations of functioning of rehabilitation interest in adults with COVID-19 or post COVID-19 condition (PCC). EVIDENCE ACQUISITION: We ran the searches on February 17th, 2023, in the following databases: PubMed, EMBASE, CENTRAL, CINHAL, and the Cochrane COVID-19 Study Register, applying a publication date restriction to retrieve only papers published in 2022. To retrieve papers published before 2022, we screened the reference lists of previous publications included in the REH-COVER action, covering papers from early 2020 to the end of 2022. This current review includes only randomised controlled trials and concludes the rapid living systematic reviews of the Cochrane Rehabilitation REH-COVER action. The risk of bias and certainty of evidence were evaluated in all studies using the Cochrane Risk of Bias tool and GRADE, respectively. We conducted a narrative synthesis of the evidence. PROSPERO registration number: CRD42022374244. EVIDENCE SYNTHESIS: After duplicate removal, we identified 18,950 individual records and 53 RCTs met the inclusion criteria. Our findings suggest that the effect of breathing and strengthening exercise programs on dyspnea and physical exercise capacity compared to no treatment in non-severe COVID-19 patients is uncertain. Multicomponent telerehabilitation may slightly increase physical exercise capacity compared to educational intervention in adults with PCC. There is, however, uncertainty about its effect on lung function and physical exercise capacity when compared to no treatment. Finally, the effect of inspiratory muscle training on maximal inspiratory pressure compared to no treatment in adults with PCC is uncertain. CONCLUSIONS: Interventions that are part of comprehensive pulmonary rehabilitation approaches may benefit dyspnea and exercise tolerance in adults with COVID-19 and PCC. The available evidence has several methodological limitations that limit the certainty of evidence and the clinical relevance of findings. Therefore, we cannot provide robust suggestions for practice. While high-quality RCTs are being conducted, clinicians should consider using high-quality evidence from other pulmonary conditions to rehabilitate patients with COVID-19 or PCC using context-specific interventions.

Impact of the Free-Pelvis Innovation in Very Rigid Braces for Adolescents with Idiopathic Scoliosis: Short-Term Results of a Matched Case-Control Study.

We introduced pelvis semi-rigid material (ethylene vinyl acetate) (Free-Pelvis) to improve the comfort and adaptability of very rigid braces (VRBs) for adolescents with idiopathic scoliosis (AIS), but this can also negatively impact the corrective forces on the trunk. Study Design: This was a matched retrospective cohort study. The inclusion criteria were AIS, age 10-16, VRB 23 h/day, X-rays available, primary curve 36°-65°, and angle of trunk rotation 7-23°. The cases were Sforzesco VRB with Free-Pelvis (FPB). The controls included classical Sforzesco VRB matched for Risser (range 0/4), menarche age (10/15), weight (33.5/83 kg), height (140/180 cm), BMI (13.5/29 kg/sqm), aesthetics (TRACE 4/12), plumbline distances (S1: -60/35; C7 + L3: -10/115 mm), and referred brace use (22/24 h/day). Statistics: predictors of the results have been tested with linear and logistic regression according to the outcome variable type. We performed logistic regression for improved vs. worsened. The explanatory variable was brace type. We included 777 VRB and 25 FPB, age 13 ± 1, 47° ± 8° Cobb, and 11% men. The few baseline statistical differences were not clinically relevant. We achieved in-brace corrections of 15.2° ± 7.7° and 17.4° ± 6.5° for VRB and FPB, respectively (p = 0.21); out-of-brace corrections at 5 ± 2 months were 7.8° ± 0.2° for VRB and 8.1° ± 1.3° for FPB (p = 0.83). The type of brace did not influence the Cobb angle at either time interval or affect the odds of improvement. Free-Pelvis innovation, introduced to improve comfort and adaptability, does not change the in-brace or short-term results of classical VRB and consequently can be safely applied.

Predicting final results of brace treatment of adolescents with idiopathic scoliosis: first out-of-brace radiograph is better than in-brace radiograph-SOSORT 2020 award winner.

PURPOSE: In-brace radiograph of adolescents with idiopathic scoliosis (AIS) has been shown to reflect brace efficacy and the possibility of achieving curve correction. Conversely, the first out-of-brace radiograph could demonstrate the patient's ability to maintain the correction. We aimed to determine which of the two radiographs is the best predictor of the Cobb angle at the end of treatment (final radiograph). DESIGN: Retrospective cohort study of a prospective dataset. METHODS: The population was selected based on the following inclusion criteria: AIS, age 10-18 years; Risser score 0-2; Cobb angle 25-40°; brace treatment; availability of all radiographs. STATISTICS: Pearson correlations provide a first exploration of data. The univariate and multivariate logistic regression model tested the predictors. Finally ROC curve provided a check of model accuracy. RESULTS: A total of 131 patients were included (mean age 13.0 ± 1.3, Cobb angle 33.2 ± 5.5°; 78% females). At the end of treatment, 56% had stabilised, 9% had progressed, and 44% had improved. The difference between the in-brace and final radiographs was 8.0 ± 6.0°, while the difference between the first out-of-brace and final radiographs was 1.8 ± 5.2°. The best predictor of final outcome was the first out-of-brace radiograph (0.80), compared to in-brace (0.68) and baseline (0.59) radiographs. The best cut-offs to predict avoidance of progression were 30% and 10% of the correction rates for the in-brace and first out-of-brace radiographs, respectively. CONCLUSION: The first out-of-brace radiograph predicts end results better than the in-brace radiograph. It offers an excellent clinical reference for clinicians and patients. The first out-of-brace radiograph should be considered an essential element of future predictive models. LEVEL OF EVIDENCE 1: Diagnostic: individual cross-sectional studies with consistently applied reference standard and blinding.

Efficacy of robotic exoskeleton for gait rehabilitation in patients with subacute stroke : a systematic review.

BACKGROUND: Stroke is the most common cause of disability in Western Countries. It can lead to loss of mobility, capability to walk and ultimately loss of independence in activities of daily living (ADL). Several rehabilitative approaches have been proposed in these years. Robot-assisted gait rehabilitation (RAGT) plays a crucial role to perform a repetitive, intensive, and task-oriented treatment in stroke survivors. However, there are still few data on its role in subacute stroke patients. AIM: The aim of the present study was to assess the efficacy of RAGT for gait recovery in subacute stroke survivors. DESIGN: Systematic review with meta-analysis. SETTING: The setting of the study included Units of Rehabilitation. POPULATION: The analyzed population was represented by subacute stroke patients. METHODS: PubMed, Scopus, Web of Science, CENTRAL, and PEDro were systematically searched until January 18, 2021, to identify randomized controlled trials (RCTs) presenting: stroke survivors in subacute phase (≤6 months) as participants; exoskeleton robots devices as intervention; conventional rehabilitation as a comparator; gait assessment, through qualitative scales, quantitative gait scales or quantitative parameters, as outcome measures. We also performed a meta-analysis of the mean difference in the functional ambulation category (FAC) via the random effect method. RESULTS: Out of 3188 records, 14 RCTs were analyzed in this systematic review. The 14 studies have been published in the last 14 years (from 2006 to 2021) and included 576 stroke survivors, of which 306 received RAGT, and 270 underwent conventional rehabilitation. Lokomat robotic system was the most investigated robotic exoskeleton by the RCTs included (N.=9), albeit the meta-analysis demonstrated a non-significant difference of -0.09 in FAC (95% CI: -0.22.0.03) between Lokomat and conventional therapy. According to the PEDro scale, 11 (78.5%) were classified as good-quality studies, two as fair-quality studies (14.3%), and one as poor-quality study (7.1%). CONCLUSIONS: Taken together, these findings showed that RAGT might have a potential role in gait recovery in subacute stroke survivors. However, further RCTs comparing the efficacy of RAGT with conventional physical therapy are still warranted in the neurorehabilitation field. CLINICAL REHABILITATION IMPACT: This systematic review provides information on the efficacy of RAGT in allowing subacute stroke patients to perform high-intensity gait training with a lower physical burden on PRM professionals.

Rehabilitation and COVID-19: rapid living systematic review by Cochrane Rehabilitation Field - third edition. Update as of June 30th, 2021.

INTRODUCTION: This paper updates and summarizes the current evidence informing rehabilitation of patients with COVID-19 and/or describing the consequences of the disease and its treatment. EVIDENCE ACQUISITION: Studies published from May 1st to June 30th, 2021 were selected, excluding descriptive studies and expert opinions. Papers were categorized according to study design, research question, COVID-19 phase, limitations of functioning of rehabilitation interest, and type of rehabilitation service involved. From this edition, we improved the quality assessment using the Joanna Briggs Institute checklists for observational studies and the Cochrane Risk of Bias Tool for randomized-controlled clinical trials (RCTs). EVIDENCE SYNTHESIS: Twenty-five, out of 3699 papers, were included. They were three RCTs, 13 cross-sectional studies and nine cohort studies. Twenty studies reported data on symptom prevalence (N.=13) or disease natural history (N.=7); and five studies reported intervention effectiveness at the individual level. All study participants were COVID survivors and 48% of studies collected information on participants 6 months or longer after COVID-19 onset. The most frequent risks of bias for RCTs concerned weaknesses in allocation concealment, blinding of therapists, and lack of intention-to-treat analysis. Most analytical studies failed to identify or deal with confounders, describe or deal with dropouts or eventually perform an appropriate statistical analysis. CONCLUSIONS: Most studies in this updated review targeted the prevalence of limitations of functioning of rehabilitation interest in COVID-19 survivors. This is similar to past review findings; however, data in the new studies was collected at longer follow-up periods (up to one year after symptom onset) and in larger samples of participants. More RCTs and analytical observational studies are available, but the methodological quality of recently published studies is low. There is a need for good quality intervention efficacy and effectiveness studies to complement the rapidly expanding evidence from observational studies.

A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis.

Combining evidence-based medicine and shared decision making, current guidelines support an evidence-based personalised approach (EBPA) for idiopathic scoliosis in adolescents (AIS). EBPA is considered important for adolescents' compliance, which is particularly difficult in AIS. Benchmarking to existing Randomised Controlled Trials (RCTs) as paradigms of single treatments, we aimed to check the effectiveness and burden of care of an EBPA in high-risk AIS. This study's design features a retrospective observation of a prospective database including 25,361 spinal deformity patients < 18 years of age. Participants consisted of 1938 AIS, 11-45° Cobb, Risser stage 0-2, who were studied until the end of growth. EBPA included therapies classified for burdensomeness according to current guidelines. Using the same inclusion criteria of the RCTs on exercises, plastic, and elastic bracing, out of the 1938 included, we benchmarked 590, 687, and 884 participants, respectively. We checked clinically significant results and burden of care, calculating Relative Risk of success (RR) and Number Needed to Treat (NNT) for efficacy (EA) and intent-to-treat analyses. At the end of growth, 19% of EBPA participants progressed, while 33% improved. EBPA showed 2.0 (1.7-2.5) and 2.9 (1.7-4.9) RR of success versus Weinstein and Coillard's studies control groups, respectively. Benchmarked to plastic or elastic bracing, EBPA had 1.4 (1.2-1.5) and 1.7 (1.2-2.5) RR of success, respectively. The EBPA treatment burden was greater than RCTs in 48% of patients, and reduced for 24% and 42% versus plastic and elastic bracing, respectively. EBPA showed to be from 40% to 70% more effective than benchmarked individual treatments, with low NNT. The burden of treatment was frequently reduced, but it had to be increased even more frequently.

Case Report: Rehabilitation After Platelet-Rich Growth Factors' Intra-Articular Injections for Knee Osteoarthritis: Two Case Reports of a Home-Based Protocol.

Knee osteoarthritis (KOA) is a chronic progressive disease that can cause pain, functional impairment, and ultimately disability. A novel and promising therapeutic approach to KOA is the so-called regenerative medicine, a set of procedures designed to harness tissue regenerative capacity and optimize functional recovery. Increasing evidence points out that platelet-rich plasma (PRP) intra-articular injections can decrease pain and improve functional abilities in KOA patients. In the present case reports, we analyze two patients who were treated with PRP injections coupled with a posttreatment home-based rehabilitation program. The two patients were selected to represent two different populations: patient 1 was an 85-year-old with severe impairment of functional abilities, while patient 2 was a younger (59 years old) and more active patient. The protocol consisted in a series of exercise to be performed at home, during the five days following PRP injection for two consecutive weeks (10 days in total). The exercises were designed to reduce the inflammation after the injection, enhance the proprioceptive control of the treated lower limb, and strengthen hip and knee flexors and extensors, mainly by isometric work. Results were evaluated at two time points: before and 2 months after the first PRP injection. The outcomes considered were as follows: visual analog scale for pain, EuroQol 5 dimensions questionnaire, Tegner Activity Scale for functioning, and Knee Injury and Osteoarthritis Outcome Score (KOOS). Both patients did not report any side effects from the treatment. Improvement in patient 1 was drastic at the two months follow-up as far as pain and functional abilities are concerned. Patient 2's improvement was less evident, probably due to the higher starting point in both pain and functionality. Overall, the developed program seemed safe and was tolerated by the patients analyzed in the study, who performed it with good compliance.

Robot-Assisted Gait Training in Patients with Multiple Sclerosis: A Randomized Controlled Crossover Trial.

Background and Objectives: Gait disorders represent one of the most disabling aspects in multiple sclerosis (MS) that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. The aim of this study is to evaluate the effectiveness of robot-assisted gait training (RAGT) in association with physiotherapy treatment in patients affected by MS in comparison with ground conventional gait training. Study design: Randomized controlled crossover trial. Materials and Methods: Twenty-seven participants affected by MS with EDSS scores between 3.5 and 7 were enrolled, of whom seventeen completed the study. They received five training sessions per week over five weeks of conventional gait training with (experimental group) or without (control group) the inclusion of RAGT. The patients were prospectively evaluated before and after the first treatment session and, after the crossover phase, before and after the second treatment session. The evaluation was based on the 25-foot walk test (25FW, main outcome), 6 min walk test (6MWT), Tinetti Test, Modified Ashworth Scale, and modified Motricity Index for lower limbs. We also measured disability parameters using Functional Independence Measure and Quality of Life Index, and instrumental kinematic and gait parameters: knee extensor strength, double-time support, step length ratio; 17 patients reached the final evaluation. Results: Both groups significantly improved on gait parameters, motor abilities, and autonomy recovery in daily living activities with generally better results of RAGT over control treatment. In particular, the RAGT group improved more than control group in the 25FW (p = 0.004) and the 6MWT (p = 0.022). Conclusions: RAGT is a valid treatment option that in association with physiotherapy could induce positive effects in MS-correlated gait disorders. Our results showed greater effectiveness in recovering gait speed and resistance than conventional gait training.

Rest-activity daily rhythm and physical activity levels after hip and knee joint replacement: the role of actigraphy in orthopedic clinical practice.

Elective hip and knee joint replacement for osteoarthritis are cost-effective surgical procedures requiring specific rehabilitation programs. Actigraphy is widely used in both research and clinical practice to study activity patterns with great accuracy and validity but it has never been utilized in orthopedic patients. Therefore, the aim of this study was to objectively assess, through actigraphy, physical activity (PA) levels and rest-activity daily rhythm (RAR) in patients undergoing hip or knee joint replacement and hospitalized for ten days after surgery. Twenty subjects (11 males and 9 females; age: 62.68 ± 10.39 years old; BMI: 29.03 ± 3.92 kg/m2) wore the Actiwatch 2 actigraph (Philips Respironics, Portland, OR) to record both PA levels and RAR for 11 consecutive days and data on subjective scores of pain, by a visual analog scale (VAS), and functional and clinical scores were collected. The following time-points were considered for the statistical analysis: pre-surgery (PRE), the first (POST1), the fourth (POST4) and the tenth (POST10) day after surgery. RAR were processed with the population mean cosinor to describe the rhythm's characteristics (acrophase, amplitude and MESOR) while data on actigraphy-based PA, VAS, and functional clinical scores were compared among PRE, POST1, POST4 and POST 10 with the RM-ANOVA or the non-parametric Friedman test. The day after surgery the subjects had a flattened RAR compared to the other conditions: lower values were detected in POST1 compared to both PRE, POST4 and POST10 for MESOR (p < .0001; η2p = .71, large) and amplitude (p < .0001; η2p = .63, large) while RAR's acrophase (p < .0001; η2p = .61, large) was delayed in PRE (16:45) compared to POST1 (12:42), POST4 (14:38), and POST10 (14:38). PA levels were significantly lower at POST 1 (76.7 ± 33.4) compared to PRE (192.3 ± 91.5; p < .0001 and ES: 1.68, large), POST4 (137.9 ± 45.9; p < .0001 and ES: 1.54, large), and POST10 (131.2 ± 54.3; p < .0001 and ES: 1.21, large) whereas VAS and functional clinical values significantly improved at POST10. Hip and knee joint replacement negatively influenced RAR and PA the first day after surgery but a progressive improvement in the circadian pattern of rest-activity cycle, PA levels, VAS and functional ability was recorded from POST4 to POST10. Actigraphy has the ability to collect real-life data without interfering with clinical practice and give clinicians a new measure of performance that is currently not available. This tool could allow to identify patients with disrupted circadian rhythm and reduced PA in the peri-operative period in orthopedic surgery, and timely intervene on these subjects with personalized rehabilitative intervention.

Reliability of activity monitors for physical activity assessment in patients with musculoskeletal disorders: A systematic review.

BACKGROUND: Activity monitors have been introduced in the last years to objectively measure physical activity to help physicians in the management of musculoskeletal patients. OBJECTIVE: This systematic review aimed at describing the assessment of physical activity by commercially available portable activity monitors in patients with musculoskeletal disorders. METHODS: PubMed, Embase, PEDro, Web of Science, Scopus and CENTRAL databases were systematically searched from inception to June 11th, 2020. We considered as eligible observational studies with: musculoskeletal patients; physical activity measured by wearable sensors based on inertial measurement units; comparisons performed with other tools; outcomes consisting of number of steps/day, activity/inactivity time, or activity counts/day. RESULTS: Out of 595 records, after removing duplicates, title/abstract and full text screening, 10 articles were included. We noticed a wide heterogeneity in the wearable devices, that resulted to be 10 different types. Patients included suffered from rheumatoid arthritis, osteoarthritis, juvenile idiopathic arthritis, polymyalgia rheumatica, and fibromyalgia. Only 3 studies compared portable activity trackers with objective measurement tools. CONCLUSIONS: Taken together, this systematic review showed that activity monitors might be considered as useful to assess physical activity in patients with musculoskeletal disorders, albeit, to date, the high device heterogeneity and the different algorithms still prevent their standardization.