Author: Rachael Hansford

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

Blumenweg 8 · 88454 Hochdorf · Germany

Phone +49 7355–93 14–0 · Fax +49 7355–93 14–15

info@thera-trainer.de · www.thera-trainer.de/en

• 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 positive results 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.

² Zebinix^® (eslicarbazepine acetate) Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000988/WC500047225.pdf Accessed January 2018.

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.

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.