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Devices for dignity / Head up collar case study

 

Contents

The Head Up Collar

The development of a novel cervical orthosis to support neck weakness due to neurological disease

Many people with neurological conditions develop neck muscle weakness, leading to pain and restricted movement, as well as problems with swallowing, breathing and communication. The Head Up Collar helps to alleviate these problems.

Clinical requirement

There are around 35,000 people in the UK and USA currently living with Motor Neurone Disease (MND) / Amyotrophic Lateral Sclerosis (ALS) and a further 5500 – 6000 people in the UK living with a form of Spinal Muscular Atrophy. Severe weakness of the neck has been described in both of these disorders. Neck weakness and consequent head drop can increase problems with communication, swallowing, breathing, mobility, and pain.

Current practice and guidelines for care of patients with MND/ALS recommend the use of neck orthoses to compensate for neck weakness and provide support. Patients describe orthoses that are currently available as uncomfortable and restrictive.

The solution

The project was initially proposed by a Clinical Studies Group for MND, with support from carers and patients, who view the current cervical orthoses as inadequate in terms of function and comfort.

A collaborative project led by the University of Sheffield, partnering with D4D, the Motor Neuron Disease Association (MNDA) charity and Sheffield Hallam University obtained NIHR i4i funding to work in collaboration with patients, carers, designers, physiotherapists and a consultant neurologist to develop a new orthotic collar. The project has developed the Head Up Collar, a CE marked class 1 medical device that is currently being trialled with patients with neck weakness as a result of their neurological condition across 10 sites in the UK and Ireland. We have worked with Capatex Ltd, Techneopro, Charles Day (Steels) Ltd, and the Helping Hand Company to develop the materials and manufacturing methods for the device.

D4D has taken the lead role with regard to project management and clinical trial management to ensure the project delivers against its objectives, as well as the regulatory arrangements through to the granting of the CE mark. It is through D4D’s Core Team that the study was able to re-open on the NIHR CRN Portfolio. In parallel to this activity, D4D has also been active in managing the IP aspects of this device and in exploring the most suitable business/manufacturing partners to ensure this product is licenced with a suitable return on investment to the NHS while offering the product to patients at an affordable price.

The impact

Whilst the cervical orthosis developed as a result of this project uses MND as a case condition, it will also benefit individuals with weakness of the neck muscles due to other diseases, such as stroke, myopathy, dystonia and multiple sclerosis. In addition to the 5000 people in the UK living with MND/ALS, there is also an estimated 100,000 people living with multiple sclerosis and 250,000 people living with the effects of stroke.

Having spoken with healthcare professionals, it is clear that there is a need in the cervical orthoses market for a collar that provides support, without restricting movement, which is exactly what the Head Up Collar offers. Early feedback from patients and carers involved in the current trial has been extremely positive and encouraging:

“No comparison to other collars – it works”
 
“This collar gives support but also freedom of movement – I can wear it to drive.”
 
“My head is better positioned therefore do not feel as tired as before having the head resting on my chest.”

The Head Up Collar was designed, developed and produced by a project team from NIHR Devices for Dignity Healthcare Technology Co-operative (HTC), the University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Hallam University, Barnsley Hospital NHS Foundation Trust, and the Motor Neurone Disease Association (MNDA), with industry support. Funding has been provided through the NIHR i4i funding programme, MNDA and NIHR Devices for Dignity HTC, totalling £465,000.