Advice
The technology
The technology
The Mollii suit (Inerventions), previously known as the Elektrodress, is a jacket and trousers that are designed to give therapeutic electrical stimulation to people with muscle spasticity.
The Mollii suit is a full-body garment which uses a type of transcutaneous electrical nerve stimulation (TENS). It delivers electrical stimulation to the wearer's skin through electrodes in the suit. The Mollii suit includes 58 electrodes, a subset of which are activated for each person, depending on the muscle pairs being targeted. The electrical stimulation is intended to stimulate the sensory nerves through the muscle spindles, while avoiding contraction of the muscle spindles themselves, so-called 'sub-threshold sensory stimulation'. The suit has a programmable control unit. Negative side effects have been reported to be minimal and short lived (for example, tingling but no pain).
The device is designed for home use after an initial assessment, in which a trained therapist sets the device settings to the individual's needs. The settings are saved to allow for home use with minimal training. The Mollii suit is worn for 60 to 90 minutes every other day, with the aim of reducing muscle spasticity and improving movement for up to 48 hours after each session. The company states that with regular use the effects may extend beyond 48 hours, and that the system is suitable for long-term use.
The device can be worn by both adults and children with muscle spasticity caused by brain injury (for example, because of stroke or cerebral palsy). It aims to reduce muscle stiffness and undesired reflexes. This enables improved muscle and joint movements, including greater balance and muscle control. The Mollii suit is available in 26 different sizes and is suitable for children aged 2.5 years and over (about 95 cm) up to adults with a maximum weight of 19 stones (120 kg).
Innovations
The potentially innovative aspect of the Mollii suit is the sub-threshold sensory electrical stimulation to cause reciprocal inhibition of the muscles.
The design of the full-body suit is intended to target a range of different muscles simultaneously, rather than focusing on an isolated muscle contraction. This is claimed to improve muscle tone, range, control and movement.
The Mollii suit is designed to address several muscle and motor function problems. The manufacturer proposes that it therefore differs from most TENS and functional electrical stimulation devices, which are more commonly used for a specific indication, for example, to reduce pain in a localised area or to help walking.
Current NHS pathway
Currently, a person with a motor function or muscle tone disorder will typically be referred to secondary care. Many different management techniques are used depending on the severity of spasticity. Management may be directed by different professionals (a paediatrician or paediatric neurologist, physiotherapist, occupational therapist, orthotist, surgeon, parent or carer).
Management approaches will be determined by each person's specific health condition. They can include: physical and occupational therapy, orthoses, and pain and spasticity medication (for example, baclofen, diazepam or local injection of botulinum toxin type A). In certain people, surgery (for example, orthopaedic surgery or selective dorsal rhizotomy) may be also considered. NICE guidance on managing spasticity in under 19s gives options specifically for children.
Population, setting and intended user
The Mollii suit can be used for adults and children with muscle spasticity or other motor function disorders. Examples of relevant populations include, but are not limited to, people with neurological disease such as cerebral palsy or multiple sclerosis, stroke, acquired brain injury and spinal cord injury. The Mollii suit could be considered as well as, or instead of, standard treatment options, including functional electrical stimulation, in several different post-acute care pathways. However, it is expected that all people using the Mollii suit would continue with physical therapy and exercise treatments. Because the suit is not yet used within the NHS, it is not clear how the Mollii suit would be integrated into existing pathways. Current NHS practice is unlikely to change substantially if the Mollii suit is used as part of the current treatment options.
Before starting treatment with the Mollii suit, the person is assessed to identify their individual response and whether the device is effective. The treatment is deemed to be suitable for the person if they show a noticeable neurological response, such as reduced spasticity or reduced pain. The manufacturer states that people with spasticity, high muscle tone, over activity or balance issues tend to show the most noticeable responses during the initial assessment.
After the initial assessment in an outpatient or inpatient secondary care setting, the Mollii suit is mainly intended to be used at home (with additional help from a carer if needed). It may also be used in an inpatient or outpatient setting in hospitals and rehabilitation centres.
If the Mollii suit were to be adopted by the NHS, appropriately trained physiotherapists or other clinicians would offer it to people for whom it would be suitable. Training takes 2 days and covers the theoretical and practical aspects of the technology. Therapists must have enough knowledge and experience in neurophysiology to be suitable for training. No formal training is needed for the person having the Mollii suit, or their carer.
Costs
Technology costs
The 2017 list price of the Mollii suit and its consumables is £4,100 (excluding VAT). This includes the initial assessment and programming of the device, as well as a follow-up assessment with a Mollii suit-trained clinician or therapist. Growing children and some adults may need reassessment to adjust the suit settings. These sessions are provided by the company and currently cost £100 to £150. The cost of an NHS physiotherapist's time to do an assessment is expected to be similar (grade and setting dependent; PSSRU 2016). Alterations for size and fit of the suit cost between £190 and £260 (excluding VAT).
The manufacturer's warranty for the device is 2 years, but it is expected that an adult can use the device for 3 to 4 years. The lifespan of the device is expected to be shorter with children because they are growing, but if a suit is returned within 1 year, another new or reconditioned garment may be bought at half the cost. The Mollii suit is sold with 4 AAA rechargeable batteries and a wall charger. Depending on the person's patterns of use, batteries should allow 4 to 6 sessions of use before they need recharging. It is expected that the batteries will need replacing after 1 to 2 years of use. The cost of replacement batteries, as well as home washing of the garment, is expected to be incurred by the person using the device.
Costs of standard care
Several options are available in current standard NHS care. The least costly therapeutic option is oral baclofen, costing £40.30 per year for a 60 mg/day dose (Drug Tariff January 2017), in addition to the costs of monitoring and consultations. Local injection with botulinum toxin twice yearly has an estimated annual cost of £870 and £1,263 for adults and children respectively, including follow-up but not the first initial consultation for treatment (NHS reference costs 2015/16). Intrathecal baclofen therapy, taking into account the implantable pump lifetime (7 years), has an average annual cost of £2,093 and £3,318 for adults and children respectively (NHS reference costs 2015/16; Drug Tariff January 2017). The annual cost of staff time for physiotherapy once per week is about £6,686 (PSSRU 2016). The cost of selective dorsal rhizotomy surgery is estimated at £25,362 (NICE guideline on spasticity).
Resource consequences
The Mollii suit is currently provided by private or third-sector health organisations. Some NHS trusts have been involved with initial assessments of the technology but it is not currently in routine NHS use.
If the Mollii suit were shown to improve clinical outcomes compared with current interventions, it has the potential to be cost neutral or cost saving, for example, through reduced length of stay if used concurrently in hospital rehabilitation, or reduced need for health and social support because of improved rehabilitation outcomes. Cost savings could also result if the technology was shown to reduce the need for concurrent medication or the need for surgery. However, if the Mollii suit was adopted as an adjunct to existing therapies, more costs might be incurred, especially if there was no long-term reduction in medication use or surgical procedures.
Because of variation in practice and the different needs and severity of spasticity in people affected by the various conditions mentioned, the resource impact of adopting this technology is highly uncertain. However, it is not anticipated that the adoption of this technology would present practical difficulties or need changes in facilities and infrastructure.