VP92 Portable Robotic Exoskeleton Stride Management Assist (SMA®)

2019 ◽  
Vol 35 (S1) ◽  
pp. 95-95
Author(s):  
Luis María Sánchez-Gómez ◽  
Ana Isabel Hijas-Gómez ◽  
Mar Polo-DeSantos ◽  
Setefilla Luengo-Matos
Keyword(s):  
Energy Expenditure ◽  
Conventional Therapy ◽  
New Technologies ◽  
Adult Population ◽  
Safety Data ◽  
Gait Training ◽  
Cochrane Library ◽  
Early Assessment ◽  
Robotic Exoskeleton ◽  
Gait Parameters

IntroductionThe Stride Management Assist (SMA®) device consist in a portable robotic exoskeleton designed for gait rehabilitation and training by repetition of walking patterns with automated regular gait cycles. Used for adult population with gait disorders of neurological or musculoskeletal origin that require rehabilitation. The objective of this work is to assess its efficacy and safety.MethodsThis technology was identified by the early Awareness and Alert System, “SINTESIS-new technologies” of AETS-ISCIII. An early assessment of the technology was conducted. The searched databases were: Pubmed, Embase, WOS, Tripdatabase, ClinicalTrials.org and Cochrane Library. Clinical studies using the device published in any language until 10 October 2018 were reviewed.ResultsWe found 3 abstracts to congresses and 6 clinical trials that evaluated the use of the device. Outcomes measures among studies included spatiotemporal gait parameters, energy expenditure, muscular activity and functional performance. Five studies consisted in proof-of-concept analysis; 3 studies evaluated the effect of gait training with SMA® compared with conventional therapy alone in individuals after stroke (2 studies) and Parkinson disease (1 study); and 1 before-and-after study assessed the effect of gait training with SMA® in elderly adults. During its use, improvements in spatiotemporal gait parameters were described in 4/5 studies, and 2/5 studies showed less energy expenditure versus 2/5 studies that found no differences. After gait training, 3/4 studies described greater improvements in gait parameters when associated its use. Only one clinical trial collected safety data reporting no adverse events.ConclusionsThe SMA® device allows to increase the efficiency and parameters of the march during its use. The assistance in the stride might have an impact on health by facilitating the recovery of the gait; however, further research is needed to determine the feasibility in the latter case since comparative studies with conventional therapy are limited.

PP012 Efficacy And Safety Of The ELIPSE Gastric Balloon For Weight Loss

2017 ◽  
Vol 33 (S1) ◽  
pp. 72-73
Author(s):  
Luis María Sánchez-Gómez ◽  
Setefilla Luengo-Matos ◽  
Mar Polo-Desantos ◽  
Juan Pablo Chalco Orrego
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
New Technologies ◽  
Cochrane Library ◽  
Gastric Balloon ◽  
Efficacy And Safety ◽  
Early Assessment ◽  
The Mean ◽  
The Impact

INTRODUCTION:Conventional gastric balloons for weight loss require endoscopy for placement and removal. The ELIPSETM is a new gastric balloon designed for weight loss that is swallowed and does not require endoscopy or anesthesia. The device is designed to remain in the stomach and be expelled after a predetermined time of 4 months. The objective of this work is to assess the efficacy and safety of the ELIPSETM procedureless gastric balloon for weight loss.METHODS:The ELIPSETM procedureless gastric balloon was identified by the early Awareness and Alert System, “SINTESIS-new technologies,” of The Instituto De Salud Carlos III (AETS-ISCIII). An early assessment of the technology was conducted. The searched databases were: MEDLINE (PubMed), Centre for Reviews and Dissemination, and the Cochrane Library. Clinical studies using the device published in any language until 10 January 2017 were reviewed.RESULTS:A prospective, non-randomized, open label study supported by industry was retrieved. Thirty-four patients were enrolled. Six patients treated with an experimental device were excluded. Twenty-eight patients successfully swallowed the device. No endoscopy or anesthesia was required. All devices were excreted safely. Of the twenty-five patients finally studied, the mean percent total body weight loss was 10 percent (95 percent Confidence Interval, CI 7.3–12.7) and the mean waist circumference was reduced by 8.4cm (95 percent CI 5.7-11.8) at 4 months. Improvements were also seen in metabolic parameters (HbA1c, Low density lipoprotein, triglycerides and blood pressure). All aspects of quality of life measured by the Impact of Weight on Quality of Life (IWQoL) questionnaire demonstrated significant improvements. About safety, there were no serious adverse events or serious adverse device effects, however 64 percent of patients had vomiting, 54 percent experienced nausea, 25 percent had abdominal pain and 2 patients were excluded because of symptoms.CONCLUSIONS:The ELIPSETM gastric balloon for weight loss seems to be an effective therapy with an acceptable safety profile. However it would be necessary to continue further studies to confirm these results, including comparative studies with current treatments.

PD48 OTL38, A Tumour-Specific Agent In Surgery For Ovarian Cancer

2018 ◽  
Vol 34 (S1) ◽  
pp. 146-146
Author(s):  
Mar Polo-Desantos ◽  
Setefilla Luengo-Matos ◽  
Juan Pablo Chalco Orrego ◽  
Luis María Sánchez-Gómez
Keyword(s):  
Ovarian Cancer ◽  
Adverse Events ◽  
Cytoreductive Surgery ◽  
Near Infrared ◽  
New Technologies ◽  
Imaging System ◽  
Folate Receptor ◽  
Cochrane Library ◽  
Control Group ◽  
Early Assessment

Introduction:Ovarian cancer (OC) has the highest mortality rate of all gynecologic malignancies. Completeness of cytoreductive surgery is a key prognostic factor for survival. To differentiate clearly between malignant and healthy tissue is essential for achieving complete cytoreduction. Using current approaches, this differentiation is difficult and can lead to incomplete tumour removal. OTL38 is a folate analogue conjugated to a near-infrared fluorescent dye which has high specificity and affinity for folate receptor alpha (FRα) expressed in OC. OTL38 together with a specific imaging system can help the surgeon to visualize diseased tissue. The objective of this work is to know the effectiveness and safety of OTL38 in of OC surgery.Methods:Early assessment of OTL38 identified through the early-awareness and alert-system, “SINTESIS-new technologies”, of AETS-ISCIII. The searched databases were: PubMed, WOS, Tripdatabase, Dynamed, Cochrane Library and ICTRP. Clinical studies using the OTL38 in cytoreductive surgery in OC published until September 2017 were reviewed.Results:Only one publication, supported by industry, was retrieved. The study assesses the pharmacokinetics and tolerability of OLT38 in 30 healthy people randomized into 4 groups with different doses and a control group. The study also analyses the percentage of cytoreduction in 12 OC patients. Infusion of 0.025, 0.05, and 0.1 mg/kg OTL38 doses was associated with mild adverse events which did not require intervention. The 0.2 mg/kg dose was associated to adverse events of moderate severity. In OC patients, 0.0125 mg/kg dose was considered the optimal dose with mild adverse events. OTL38 accumulated in FRα-positive tumours and metastases allowed the surgeon to resect an additional 29 percent of malignant lesions which were not detected using standard inspection and palpation methods.Conclusions:The OTL38 is an emergent health technology, which could help in cytoreductive surgery for ovarian cancer. However, the evidence is scarce and it would be necessary to continue further studies.

scholarly journals Effect of Virtual Reality Training on Balance and Gait Ability in Patients With Stroke: Systematic Review and Meta-Analysis

2016 ◽  
Vol 96 (12) ◽  
pp. 1905-1918 ◽  
Author(s):  
Ilona J.M. de Rooij ◽  
Ingrid G.L. van de Port ◽  
Jan-Willem G. Meijer
Keyword(s):  
Virtual Reality ◽  
Conventional Therapy ◽  
Data Extraction ◽  
Meta Analysis ◽  
Gait Training ◽  
Berg Balance Scale ◽  
Cochrane Library ◽  
Novel Therapy ◽  
Study Selection ◽  
Vr Training

AbstractBackgroundVirtual reality (VR) training is considered to be a promising novel therapy for balance and gait recovery in patients with stroke.PurposeThe aim of this study was to conduct a systematic literature review with meta-analysis to investigate whether balance or gait training using VR is more effective than conventional balance or gait training in patients with stroke.Data SourcesA literature search was carried out in the databases PubMed, Embase, MEDLINE, and Cochrane Library up to December 1, 2015.Study SelectionRandomized controlled trials that compared the effect of balance or gait training with and without VR on balance and gait ability in patients with stroke were included.Data Extraction and SynthesisTwenty-one studies with a median PEDro score of 6.0 were included. The included studies demonstrated a significant greater effect of VR training on balance and gait recovery after stroke compared with conventional therapy as indicated with the most frequently used measures: gait speed, Berg Balance Scale, and Timed “Up & Go” Test. Virtual reality was more effective to train gait and balance than conventional training when VR interventions were added to conventional therapy and when time dose was matched.LimitationsThe presence of publication bias and diversity in included studies were limitations of the study.ConclusionsThe results suggest that VR training is more effective than balance or gait training without VR for improving balance or gait ability in patients with stroke. Future studies are recommended to investigate the effect of VR on participation level with an adequate follow-up period. Overall, a positive and promising effect of VR training on balance and gait ability is expected.

PP262 PapSEEK: Liquid Biopsy For Endometrial And Ovarian Cancer Screening

2020 ◽  
Vol 36 (S1) ◽  
pp. 22-23
Author(s):  
Ana Isabel Hijas-Gómez ◽  
Mª Mar Polo-de-Santos ◽  
Setefilla Luengo-Matos ◽  
Luís María Sánchez-Gómez
Keyword(s):  
Ovarian Cancer ◽  
Endometrial Cancer ◽  
Diagnostic Accuracy ◽  
Pap Smear ◽  
New Technologies ◽  
Gynecological Cancer ◽  
Cochrane Library ◽  
Early Assessment ◽  
Preliminary Results ◽  
Tumor Types

IntroductionEndometrial and ovarian cancer are the first and second leading causes of death from gynecological cancer in Spain. Survival is generally determined by stage at diagnosis, but there is no test currently used for early detection of both tumor types. PapSEEK is a test developed to diagnose endometrial and ovarian cancer by detecting aneuploidies and somatic mutations commonly associated with both tumor types through DNA next-generation sequencing (NGS) of liquid from Papanicolaou test (Pap smear) samples. The objective of this work was to assess the effectiveness and safety of PapSEEK.MethodsPapSEEK was identified by the Early Awareness and Alert System, “SINTESIS-new technologies”, of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS-ISCIII). An early assessment of the technology was conducted through a literature search of the following databases: PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and The Cochrane Library. Clinical studies on the effectiveness and safety of PapSEEK published up to February 2019 were reviewed.ResultsThe evidence comprised proof of concept and diagnostic accuracy studies, which showed good preliminary results regarding the accuracy of the test for diagnosing endometrial cancer (sensitivity ranged from 0.81 to 0.93), but not for ovarian cancer (sensitivity ranged from 0.33 to 0.45). The specificity for both tumor types ranged from 0.99 to 1.00. Since PapSEEK uses a sampling method that is routinely used in clinical practice (the Pap smear), no evidence was found in the literature on the safety of the test.ConclusionsPapSEEK is a novel technology developed to diagnose endometrial and ovarian cancer by means of DNA-NGS of Pap smear samples. The identified studies showed good preliminary results regarding the ability of the test to diagnose endometrial cancer, but not ovarian cancer. PapSEEK may be useful as a screening tool for endometrial cancer. However, further research on PapSEEK is needed to prospectively evaluate its diagnostic accuracy, compare it with current tests used in the early diagnosis of both cancer types, evaluate its effect on patient survival and disease progression, and measure its economic impact.

PD78 Minimally Invasive Capsulorhexis In Children's Cataracts

2018 ◽  
Vol 34 (S1) ◽  
pp. 156-157
Author(s):  
Luis María Sánchez-Gómez ◽  
Setefilla Luengo-Matos ◽  
Juan Pablo ◽  
Chalco Orrego ◽  
Mar Polo-Desantos
Keyword(s):  
Minimally Invasive ◽  
Standard Treatment ◽  
New Technologies ◽  
Corneal Edema ◽  
Cochrane Library ◽  
Control Group ◽  
Early Assessment ◽  
Visual Axis ◽  
Open Label ◽  
Pediatric Cataract

Introduction:Minimally invasive capsulorhexis is an incision in the anterior capsule in the peripheral zone for cataract extraction. It allows reduction of the size of the lesion, ensuring a better transparency of the visual axis, preserving the capsule almost intact and a layer of lenticular epithelial cells. The procedure could have a potential regenerative effect of the lens in a natural way. The objective of this study is to assess the efficacy and safety of minimally invasive capsulorhexis to promote lens regeneration in children's cataracts.Methods:This technology was identified by the early Awareness and Alert System, “SINTESIS-new technologies” of Agencia de Evaluación de Tecnologías Sanitarias (AETS) Instituto de Salud Carlos III (ISCIII). An early assessment was conducted. The searched databases were: PubMed, Centre for Reviews and Dissemination (CRD), and Cochrane Library. Clinical studies using the procedure published in any language until 29 September 2017 were reviewed.Results:An open-label, randomized trial in pediatric cataract patients (age: 0–2 years) was retrieved. Twelve patients underwent minimally invasive capsulorhexis, while twenty-five patients received the standard treatment. Regarding efficacy, a transparent regenerated biconvex lens was found in 100 percent of eyes three months after surgery, but wasn't found in the control group. 100 percent of capsular openings healed within one month after surgery in the experimental group, but not in the control group. Both groups increased their visual acuity parameters without significant differences. Regarding safety, children receiving the standard technique had a higher incidence of corneal edema (eight percent in the intervention vs thirty percent in the control group), anterior chamber inflammation (seventeen percent vs seventy-four percent), additional laser capsulotomy (zero percent vs eighty-four percent) and increased visual axis opacification (four percent vs eighty-four percent).Conclusions:Minimally invasive capsulorhexis in children's cataracts seems to be a promising new procedure. Preliminary efficacy results were good and safety profile was better than standard treatment. However, it would be necessary to continue further studies to confirm these results.

Abstract TP149: Utilization of a Robotic Exoskeleton to Provide Increased Mass Practice for Gait Training and its Impact on Discharge Destination for Individuals With Acute Stroke

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Anthony Russo ◽  
Melissa A Perret ◽  
Kirk Endersby ◽  
Adam G Kesten ◽  
Marisa A King ◽  
...  
Keyword(s):  
Acute Stroke ◽  
New Technologies ◽  
Specific Activity ◽  
Gait Training ◽  
Functional Mobility ◽  
Discharge Destination ◽  
Matched Sample ◽  
Robotic Exoskeleton ◽  
Matching Criteria ◽  
The Impact

Introduction: Mass practice of task-specific activity, such as repeated stepping for gait retraining, is an integral part of acute stroke rehabilitation. New technologies including the use of a robotic exoskeleton (RE) have recently been introduced to the inpatient rehab facility (IRF). A RE can help skilled physical therapists (PT) provide repetitive stepping practice to patients who have had a stroke. Hypothesis: We hypothesize the use of a RE will enable PTs in an IRF to provide added stepping practice to their therapy program and influence discharge destination as compared to traditional treatment plans. Methods: Fifteen participants with acute stroke (<6 months post, age 58±10; height 66±5in; 176±35lbs; LOS 29±7days) were recruited for RE gait training during inpatient rehabilitation in conjunction with traditional therapy. Participants ambulated in the RE over level surfaces with the assistance of a PT (minimum of 3 sessions in the RE). Participant inclusion requirements: medical clearance, upright standing tolerance (≥15 min), intact skin, and physically fit into the device. A matched sample of participants (n=15) was selected from a hospital database (matching criteria: length of stay, admission motor FIM, age, gender and affected side). The data was analyzed using independent sample and paired sample t-tests. Results: Participants in the RE group walked an average distance of 212 feet in traditional PT where gait training was provided and 551 feet in RE sessions (p=.033). Discharge destination for the RE group: 10 home; 3 subacute; 2 nursing facilty and for the matched sample: 13 home; 2 subacute. Motor FIM scores significantly increased from admission to discharge: RE group (p≤.001) and matched group (p≤.001). Motor FIM gain at discharge in the RE group significantly increased compared to the matched sample, 26.4±6.4 vs. 21.6±5.9, (p=0.044). Conclusions: This exploratory investigation demonstrated the RE provides increased dosing of gait training. Discharge destination was not notably impacted by method of gait training. Improvement of motor FIM scores in the RE group begins to demonstrate the impact of mass practice provided by the RE. Further research is needed to objectively explore the impact of RE on functional mobility and quality of life.

BREAST CANCER SCREENING: CURRENT ACHIEVEMENTS, FUTURE PERSPECTIVES AND NEW TECHNOLOGIES

2019 ◽  
Vol 65 (5) ◽  
pp. 664-671
Author(s):  
Ilya Pyatnitskiy ◽  
O. Puchkova ◽  
Viktor Gombolevskiy ◽  
Lyudmila Nizovtsova ◽  
Natalya Vetsheva ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Screening ◽  
Breast Cancer Screening ◽  
New Technologies ◽  
Screening Program ◽  
Cochrane Library ◽  
Future Perspectives ◽  
Pubmed Database ◽  
The World ◽  
The Cochrane Library

The article presents a literature review of the PubMed database and the Cochrane library, aimed at analyzing the current situation and problems in the field of breast cancer screening in the world and Russia to form an idea of the key elements in organizing an effective screening program in the Russian healthcare system, as well as the possibilities of using new technologies when organizing such programs.

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

Medicina ◽  
2021 ◽  
Vol 57 (7) ◽  
pp. 713
Author(s):  
Cristiano Sconza ◽  
Francesco Negrini ◽  
Berardo Di Matteo ◽  
Alberto Borboni ◽  
Gennaro Boccia ◽  
...  
Keyword(s):  
Crossover Trial ◽  
Gait Training ◽  
Treatment Session ◽  
Control Group ◽  
Walk Test ◽  
Robot Assisted ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Before And After

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.

Feasibility and Preliminary Efficacy of Gait Training Assisted by Multichannel Functional Electrical Stimulation in Early Stroke Rehabilitation: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 35 (2) ◽  
pp. 131-144
Author(s):  
Maijke van Bloemendaal ◽  
Sicco A. Bus ◽  
Frans Nollet ◽  
Alexander C. H. Geurts ◽  
Anita Beelen
Keyword(s):  
Electrical Stimulation ◽  
Functional Electrical Stimulation ◽  
Step Length ◽  
Gait Training ◽  
Control Group ◽  
Significant Group ◽  
Gait Symmetry ◽  
Gait Parameters ◽  
Walking Capacity ◽  
Experimental Group

Background. Many stroke survivors suffer from leg muscle paresis, resulting in asymmetrical gait patterns, negatively affecting balance control and energy cost. Interventions targeting asymmetry early after stroke may enhance recovery of walking. Objective. To determine the feasibility and preliminary efficacy of up to 10 weeks of gait training assisted by multichannel functional electrical stimulation (MFES gait training) applied to the peroneal nerve and knee flexor or extensor muscle on the recovery of gait symmetry and walking capacity in patients starting in the subacute phase after stroke. Methods. Forty inpatient participants (≤31 days after stroke) were randomized to MFES gait training (experimental group) or conventional gait training (control group). Gait training was delivered in 30-minute sessions each workday. Feasibility was determined by adherence (≥75% sessions) and satisfaction with gait training (score ≥7 out of 10). Primary outcome for efficacy was step length symmetry. Secondary outcomes included other spatiotemporal gait parameters and walking capacity (Functional Gait Assessment and 10-Meter Walk Test). Linear mixed models estimated treatment effect postintervention and at 3-month follow-up. Results. Thirty-seven participants completed the study protocol (19 experimental group participants). Feasibility was confirmed by good adherence (90% of the participants) and participant satisfaction (median score 8). Both groups improved on all outcomes over time. No significant group differences in recovery were found for any outcome. Conclusions. MFES gait training is feasible early after stroke, but MFES efficacy for improving step length symmetry, other spatiotemporal gait parameters, or walking capacity could not be demonstrated. Trial Registration. Netherlands Trial Register (NTR4762).

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