Falling is one of the main challenges for the elderly, relatives and health care services. Regular physical activity is an important source of energy, self-reliance in everyday life and overall good health. To maintain physical function like strength and balance, we must be active. As we grow older, we lose muscle strength and our balance is reduced. The best way to limit this loss of function is to be active and spend as much time as possible in a weight-bearing, standing position. ExorLive provides easy to use exercise software for rehabilitation and sports therapists and fitness experts. Inspire your clients with quality-assured exercises. Send exercise programmes straight to an app for the client, or simply print or email.
New in ExorLive: SeniorLive SeniorLive is a series of instructional exercise videos with music. It consists of functional strength and balance training for seniors. The exercises should be performed standing with the support of a chair or walker. The programme is suited for people with reduced balance and walking function. It is also well suited as a group exercise for the elderly.
Neurokinex – provider of neurological activity-based rehabilitation – has launched the Neurokinex Charitable Trust to provide specialised neurological rehabilitation for various forms of paralysis. Established in 2013, Neurokinex is the first and only European affiliate of the Christopher & Dana Reeve Foundation’s Neuro Recovery Network. It sets out to ‘redefine possibilities’ for people with a spinal cord injury: its programmes stimulate and load the entire nervous and musculoskeletal systems through carefully crafted, task-specific exercises with the assistance of skilled therapists.
I believe that everyone living with a neurological impairment resulting from paralysis deserves access to high quality rehabilitation and wellness programmes based on the latest breakthroughs in neuroscience and neuro-restorative research,”
says Harvey Sihota, Neurokinex CEO and founder. “My hope is that by raising funds for initiatives such as a dedicated paediatric capability, individual bursaries and an innovation fund to support continuous improvement, more and more people with spinal cord injury can access our groundbreaking programmes and maximise their rehabilitation and recovery.” http://neurokinex.org/charity
medica presents an efficient best-practice model for multi-phase group therapy
With the THERA-Trainer Complete Solution for gait rehabilitation, medica Medizintechnik GmbH brings a complete device-based concept for neurological rehabilitation onto the market. The company is thus addressing the challenge, faced by many hospitals, of offering scientifically established and effective therapies despite the lack of resources, cost pressures and time constraints.
With our Complete Solution, we are successfully implementing an evidence-based, clinically proven treatment concept for the rehabilitation of the lower extremities.
Jacob Tiebel, head of product management at medica
Many hospitals need tailored strategies to work efficiently, and medica Medizintechnik GmbH’s new solution concept meets this requirement. The THERA-Trainer Complete Solution for gait rehabilitation is developed individually with each customer and is tailored to the current operating reality of each hospital. An in-depth analysis of the initial situation and a customised design of the solution ensure that space issues are taken into account and that the training and therapy devices are properly utilised. The Complete Solution is not a substitute for therapists, but instead facilitates and supports their work. In addition, it enables a single therapist to treat several patients at the same time.
A complete solution, not a piecemeal offering
With the Complete Solution concept, THERA-Trainer primarily addresses the organisational and process weaknesses in hospitals. With this approach, medica intends to harness previously untapped economic potential in hospitals, while at the same time working sustainably towards better treatment outcomes. The focus is not on the individual products, but on an optimised therapy process and the full set of devices as a complete solution. Last year, medica acquired an end-effector gait trainer through its merger with the Swiss company ability.
With the THERA-Trainer lyra, we now offer the full range of products for gait rehabilitation. The real innovation lies in integrating these products intelligently into a high-efficiency setting.
medica owner and managing director Peter Kopf
First pilot projects have been successful
The first pilot project was launched last year in collaboration with one of Germany’s largest hospital operators. The first THERA-Trainer Complete Solution was installed by medica in the neurological centre at the MEDIAN clinic in Madgeburg. This marked the beginning of intensive cooperation between the rehabilitation sector and industry.
Prof. Michael Sailer, medical director of the MEDIAN clinic in Madgeburg, is convinced: “Professional care allows us to develop a differentiated approach with the Complete Solution.” The process of carrying out a preliminary analysis of a hospital’s therapy processes, followed by the creation of new therapeutic pathways, is of vital importance for cost-effective use, Sailer continues.
With the Complete Solution for gait rehabilitation, medica is striving towards long-term cooperation and partnership with hospitals. The concept has already received positive feedback from experts, and official distribution of the THERA-Trainer Complete Solution is now underway.
THERA-Trainer® a trade mark of medica Medizintechnik GmbH
Pivotal Phase III data showed that once-daily eslicarbazepine acetate monotherapy is non-inferior to twice-daily controlled release carbamazepine for newly diagnosed epilepsy[1]
Although adverse event rates were similar in the two treatment groups, eslicarbazepine acetate treatment had lower rates of discontinuation due to adverse events than carbamazepine.1
Bial and Eisai have announced that positiveresults from a pivotal Phase III monotherapy study of once-daily Zebinix® (eslicarbazepine acetate) in newly diagnosed focal epilepsy patients have been published in the journal Epilepsia.1
The study of 815 patients met its primary endpoint, showing that treatment with eslicarbazepine acetate monotherapy was non-inferior to twice-daily controlled-release carbamazepine, the current standard of care. Eslicarbazepine acetate was also shown to be well-tolerated.1
For this patient population in particular, it is important that the physician takes into consideration individual factors and tailors treatment to the individual. We therefore welcome the news that another treatment has been shown to be effective for these patients, especially one with an easy to use once-daily formulation that has the potential to improve adherence,”
Eugen Trinka, lead author of the study, Professor and Chair, Department of Neurology, and Medical Director Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.
The primary endpoint of non-inferiority was shown through the proportion of patients seizure-free for the entire 26-week evaluation period. The data show that 71.1% (n=276/388) of patients for eslicarbazepine acetate and 75.6% (n=300/397) of patients for controlled-release carbamazepine were seizure-free for six months or more, at the last evaluated dose (average risk difference -4.28%; 95% CI: -10.3, 1.74%). The one-year seizure-freedom rate at the last evaluated dose was 64.7% (n=251/388) on eslicarbazepine acetate and 70.3% (n=279/397) on controlled-release carbamazepine (average risk difference: -5.46%; 95% CI: -11.88, 0.97%).1
Incidence rates of treatment-emergent adverse events (TEAEs) were similar in patients receiving eslicarbazepine acetate (76.3%) (n=306/401) versus controlled-release carbamazepine (79.6%) (n=328/412). It was also noted that fewer patients discontinued eslicarbazepine acetate treatment (14.0%) compared with carbamazepine-CR (18.4%), primarily driven by lower rates discontinuation due to adverse events.1
The most frequently reported possibly-related TEAEs for eslicarbazepine acetate were, in order of most frequent, dizziness, headache, somnolence, fatigue and nausea.1
Eslicarbazepine acetate is indicated in Europe as a monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy.[2] Eslicarbazepine acetate is also indicated in Europe as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.2
References
1 Trinka E, et al. (2018) Efficacy and safety of eslicarbazepine acetate versus controlled-release carbamazepine monotherapy in newly diagnosed epilepsy: A Phase III double-blind, randomized, parallel-group, multicentre study.Epilepsia. 00, 1-13.
3 Hebeisen S, et al. (2015) Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: A comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 89, 122-135.
4 Elger C, et al. (2007) Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia. 48, 497-504.
5 Elger C, et al. (2009) Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial onset seizures: A randomised, double-blind, placebo-controlled, parallel-group Phase III study. Epilepsia. 50, 454-63.
6 Ben-Menachem E, et al. (2010) Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Research. 89(2-3), 278-85.
7 Gil-Nagel A, et al. (2009) Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurologica Scandinavica. 120, 281-87.
Managed Access Agreement to be developed in parallel to urgently provide effective new treatment to patients in England
Maidenhead, UK – 19 January, 2018 – The National Institute for Health and Care Excellence (NICE) has formally invited Biogen to submit SPINRAZA (nusinersen), the first and only disease-modifying treatment for 5q spinal muscular atrophy (SMA), for assessment via the Single Technology Appraisal (STA) route. Whilst on its own this choice of route could have signalled a setback for access, the openness demonstrated by NICE and NHS England to commence development of a Managed Access Agreement straight away has reassured the company that there is still a viable, long-term reimbursement path for this significant therapeutic advancement in England.
We now have an opportunity for SMA patients in England & Wales who deserve access to nusinersen, a medicine which has the potential to address unmet medical need in a devastating disease. Whilst we have been disappointed by the delays in the NICE process so far, we have been encouraged by a recent meeting with NICE and NHS England, where the need to respond to specific STA and access challenges in appraising nusinersen was expressly acknowledged, and an immediate plan for a Managed Access Agreement that can work alongside the STA process was agreed. Now is the time for all stakeholders to work together to ensure as many patients as possible get rapid access to this life saving medicine.
Terry O’Regan, Vice President and Managing Director of Biogen UK and Ireland
Nusinersen received European marketing authorisation following accelerated assessment in May 2017, and since that time NICE has been reviewing the best route for the appraisal. So far, nusinersen is reimbursed in Italy and Sweden with ongoing negotiations taking place across Europe.
Due to the significant clinical improvements shown with nusinersen in clinical trials and the urgent need for a treatment where before there was none, Biogen opened one of the largest global expanded access programmes in rare disease (since Autumn 2016) as an interim measure for those with infantile-onset SMA (consistent with type 1). To date, all eligible children in the UK have been treated with nusinersen following a Biogen/NHS collaboration in which it was agreed that Biogen would provide the medicine free of charge, and the NHS would devise an urgent policy to administer the treatment.
What happens now?
Biogen will submit to NICE in March 2018 (in line with the submission request date), and the NICE appraisal committee will outline their initial recommendation in June 2018 – at this point, feedback will be invited from relevant stakeholders including clinicians and patient representatives. NICE then provides its recommendation on whether routine funding can be made available to patients in England via the NHS, currently scheduled for November 2018. The STA will consider nusinersen for all appropriate patients who may benefit, which extends beyond those affected by infantile-onset SMA (consistent with type 1).
Walk With Path is a health-tech start-up focused on improving mobility and reducing the risk of falls across a broad population, including the elderly and those with chronic diseases. The company launched its rst product, Path Finder, in June 2017. Since then, there has been positive feedback from people with Parkinson’s disease.
Path Finder is designed to alleviate ‘freezing of gait’ in Parkinson’s disease, by providing visual cues that act as external triggers.
The company also recently started studies with UCL, looking at how the next product, Path Feel, can aid people in improving balance. Path Feel is an insole designed to improve balance. It provides a vibrational feedback to the soles of the feet, to assist those with neuropathies and general balance issues, feel more balanced and confident.
Future falls prevention workshops will be hosted in central London next year. For more information email Neil@innervate.co.uk
ICON plc, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has contributed to a complex pan-European traumatic brain injury (TBI) research study involving over 4,500 patients in 65 sites in 20 European countries.
ICON provided site management and source data verification (SDV) services to the study, which was supported by the EU and led by Professor Andrew Maas from the University Hospital Antwerp (Belgium) and Professor David Menon from the University of Cambridge (UK). ICON’s Dr Valérie Legrand, VP Project Management and a recognised expert in CNS, also provided clinical expertise as a member of the project’s Management Committee.
The Lancet Neurology Commission on TBI was launched at the European Parliament on 7th November 2017 and set out clinical and research priorities and recommendations to address the varied challenges in TBI.
The Commission on TBI identifies 12 key recommendations and policies to improve the prevention, quality of care and clinical research in TBI. It seeks to identify strategies to better characterise TBI, increase prognostic accuracy, and adopt a more precision-medicine approach to treatments. The Commission also promotes the use of new tools for clinical evidence generation and implementation, so that research outputs can be more rapidly integrated into clinical care. Moreover, it highlights the importance of international collaboration of funding agencies and researchers to provide a global response to reduce the individual and societal burden of TBI.
Read Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research free online at http://bit.ly/2jbGfst
Veriton Pharma Ltd has been announced as the new company name for Special Products Ltd.
This name change has occurred both to incorporate the company’s past heritage with its future ambitions to make trusted medicines available for everyday living.
The Chief Commercial Officer commented:
With the launch of Epistatus® 10mg in 1mL Oromucosal Solution Midazolam (as maleate), on the 8th of September 2017, and our extensive range of existing unlicensed medicines, we would like to assure our customers and partners that the excellent service and quality they have come to expect from us as a company will continue and all contacts at the company will remain the same.”
With its legacy of technical expertise, which began in a world-renowned children’s hospital over 20 years ago, Veriton Pharma sources and supplies licensed medicines for CNS and over 75 high-quality, UK batch manufactured unlicensed medicines in the fields of epilepsy, neurology and rare paediatric conditions that licensed products cannot meet.
Headquartered in Weybridge, UK, Veriton Pharma, is a privately owned, speciality pharmaceutical company which also has regional offices in the Middle East and Australia.
Source: The Christchurch Group Published online: 8/1/18
A neurological rehabilitation centre in Lincolnshire has been rated ‘Outstanding’ by the Care Quality Commission (CQC), placing it in the top 1% of healthcare services in the UK.
The Laurels, which opened in 2014 and is run by Christchurch Group, provides specialist community-based transitional rehabilitation in north-east Lincoln. It supports adults with neurological conditions resulting from injury, illness or disease. The service offers accommodation for 12 residents and is a Headway Approved Provider.
Inspectors praised the service for its calm and caring atmosphere, its strong, values-led leadership and the creative and individualised approach to support displayed by the registered manager and staff, which provided clear therapeutic benefits for residents. The CQC also highlighted how residents were actively involved in the preparation and on-going review of their personal care plan and supported to make decisions about how they wanted to be supported.
Richard McKenzie, Christchurch Group Chief Operations Officer, added:
I am delighted that the Laurels has been awarded ‘Outstanding’ status. We are proud to deliver life-changing, evidence-based outcomes for adults with neurological conditions. To have a service recognised as being in the top 1% of regulated healthcare services in the UK is an incredible achievement.
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