ABSTRACT
Introduction: Balance impairments are common in multiple sclerosis (MS). Pilates is a popular alternative method for balance performance maintenance and improvement that may reduce the rapid symptoms worsening frequently associated with physical inactivity. An Italian network of fifteen experts in MS rehabilitation developed through a User-Centered Design approach the MS-FIT exergame, a Kinect-based tool, to autonomously train balance through Pilates exercises. The MS-FIT user executes the exercises shown by a teacher's avatar and improves the performances through the feedbacks on the execution correctness. Aim(s): This study (Clinical.Trials.gov, NCT04011579) aims at evaluating the feasibility of an at-home intervention with MS-FIT. Method(s): Feasibility was investigated in terms of adherence (sessions number), usability (usability items of Tele-healthcare Satisfaction Questionnaire, u-TSQ, satisfaction (Client Satisfaction Questionnaire, CSQ-8), safety (adverse events), and physical effectiveness (Timed UP-&-GO, TUG;Timed 25-Foot Walk, T25FW;2-Minutes Walking Test, 2MWT). Result(s): Forty-five people with MS (PwMS) were enrolled and randomized into the experimental (EXP, n=23) and control (CTRL, n=22) groups. During the 6 weeks of the study, only the usual physical activities were admitted (rehabilitation excluded) and, in addition, EXP had to practice MS-FIT at least three times a week. Due to organizational consequences of COVID pandemic, 8 subjects dropped-out (EXP, n=17;CTRL, n=20). The sample analysed showed the following characteristics: gender (EXP: 6M;CTRL: 7M), age (EXP: 41.9+/-9.6y;CTRL: 43.3+/-10.5y), course (EXP: 94.4% and CTRL: 95.0% relapsing-remitting), disease duration (EXP: 9.9+/-7.2y;CTRL: 12.5+/-9.8y) and EDSS (EXP: 2.6+/-0.8;CTRL: 2.6+/-0.8). EXP highly adhered to the MS-FIT training (23.6+/-6.1 sessions);the tool was usable (u-TSQ: 3.01/4);satisfaction was medium-tohigh (CSQ-8: 25.1/32);the training with MS-FIT was safe (no adverse events). The groups did not differ in TUG, T25FW and 2MWT. An analysis separate for each group showed a significant improvement only in EXP (TUG: pre 7.5+/-1.2s, post 7.0+/-1.2s, p<0.05;T25FW: pre 6.1+/-1.5s, post 5.0+/-1.2s, p<0.01;2MWT: pre 175.4+/-51.0m, post 194.1+/-56.9m, p<0.01). Conclusion(s): MS-FIT is well-accepted and effective and could be a complement of traditional MS interventions. Based on the results and participants' feedbacks MS-FIT has been refined and is used in an ongoing randomized controlled trial.
ABSTRACT
Introduction: Patients with multiple sclerosis (MS) often receive disease-modifying therapies (DMTs) which can reduce the response to vaccines. BNT162b2 (Pfizer-BioNTech) is the first COVID-19 vaccine authorized in Italy but was not evaluated in MS patients receiving DMTs. Objectives: To evaluate serological response and safety to BNT162b2 in patients with MS. Methods: This is an early multicenter, case-control and prospective study. Patients were healthcare workers (HCWs) with MS, receiving at least one DMT, and having received BNT162b2. Blood samples were collected between 2 and 6 weeks after the second vaccine dose and analyzed to quantify anti-Spike antibodies (Abbott). Anti-Spike cut-off for response was set at 7.1 BAU/ ml. Anti-Spike levels in patients considered at-risk of reduced response were compared to those considered non-at-risk, according to literature and expert consensus. Anti-Spike levels were compared to those of a control population of HCWs, without MS or immune-related disease, untreated, and having received BNT162b2. Total follow up was of 9 weeks from the first vaccine dose. Results: From February 2020, 39 MS patients were enrolled. One patient, treated with ocrelizumab, did not develop serological response (1.8 BAU/ml). The remaining patients responded to the vaccine, including two ocrelizumab-treated patients. The control population consisted of 273 HCWs. All controls responded to BNT162b2. Median anti-Spike levels in patients (1471.0 BAU/ ml;range 779.7-2357.0) and controls (1479.0 BAU/ml;range 813.1-2528.0) were comparable. Patients receiving at-risk treatments (n=9;5 fingolimod, 3 ocrelizumab, 1 natalizumab) showed significantly reduced median anti-Spike levels (241.9 BAU/ml;range 40.2-530.0) compared to non-at-risk (n=30;15 dimethyl fumarate, 5 teriflunomide, 4 interferons, 3 glatiramer acetate, 2 cladribine, 1 alemtuzumab) ones (1707.7 BAU/ml;range 1356.2- 2432.8) (p<0.001). No COVID-19 cases were reported. Two patients had a clinical MS relapse after 17 and 30 days after the second dose. A causal relationship with the vaccination could not be established. Conclusions: In our study, most MS patients produce a serological response to BNT162b2 similar to non-MS controls;however, at-risk DMTs resulted in reduced anti-Spike levels and one ocrelizumab- treated patient did not respond. These observations should be better investigated and replicated in larger studies to support clinical decision in COVID-19 vaccine management.
ABSTRACT
BACKGROUND: Lombardy was severely hit by the COVID-19 pandemic since February 2020 and the Health System underwent rapid reorganization. Outpatient clinics were stopped for non-urgent patients: it became a priority to manage hundreds of fragile neurological patients who suddenly had less reference points. In Italy, before the pandemic, Televisits were neither recognized nor priced. METHODS: At the Fondazione IRCCS Istituto Neurologico C. Besta, we reorganized outpatient clinics to deliver Neuro-telemedicine services, including Televisits and Teleneurorehabilitation, since March 2020. A dedicated Working Group prepared the procedure, tested the system, and designed satisfaction questionnaires for adults and children. RESULTS: After a pilot phase, we prepared a procedure for Telemedicine outpatient clinics which was approved by hospital directions. It included prescription, booking, consenting, privacy and data protection, secure connection with patients (Teams Microsoft 365), electronic report preparation and delivery, reporting, and accountability of the services. During the March-September 2020 period, we delivered 3167 Telemedicine services, including 1618 Televisits, to 1694 patients (972 adults, 722 children) with a wide range of chronic neurological disorders. We successfully administered different clinical assessment and scales. Satisfaction among patients and caregivers was very high. CONCLUSIONS: During the dramatic emergency, we were able to take care of more than 1600 patients by organizing Neuro-telehealth in a few weeks, lessening the impact of the pandemic on fragile patients with chronic neurological disorders;this strategy is now stably embedded in our care pathways. In Italy, Telehealth is at present recognized and priced and is becoming a stable pillar of the health system.