Advice
The technology
The technology
The RT300 combines functional electrical stimulation (FES) with a motorised ergometer that allows repetitive cycling activity as part of a rehabilitation programme for people with a spinal cord injury.
It stimulates muscles with electrodes attached to the skin, producing muscle contractions and patterned activity. It can stimulate muscle groups in 1 or both arms or legs and trunk in a coordinated cycling motion. The standard configuration stimulates 6 muscle groups with 1 stimulator. Another 6 muscle groups can be stimulated by an extra stimulator and 4 more can be stimulated by individual Bluetooth stimulators. Training plans vary in clinical practice. The typical training session can range from 15 to 60 minutes per session, 3 to 4 times per week. The training can last from 6 weeks up to lifetime use depending on the severity of spinal injuries.
RT300 has systems configurable for different muscle groups (arms, legs) and can be used while in a wheelchair, chair or bed. It can be used by children.
During a therapy session, the technology starts by passively cycling muscles and prepares them for exercise. Electrical stimulation then gradually activates the muscles to work up to a target speed or until muscle fatigue is detected. Different parameters can be changed depending on the person's progress, such as current amplitude and frequency, pulse width and resistance. The RT300 has an automatic setting which adjusts the ergometer resistance or the stimulation to safely get to the target speed and avoid excessive muscle movement. RT300 will stop if it detects too much muscle spasm to avoid injury. All functions of the RT300 are controlled by a tablet computer.
Innovations
The RT300 system has a motor built into the stimulation system to automatically adjust the stimulation and the ergometer resistance. This is not available in other FES systems. The company claims this allows therapy to respond to individual patient performance, to maximise muscle contractions and to give consistent and reliable outcomes.
RT300 systems use software that sends data through a secure Wi-Fi connection from the tablet computer to a cloud-based database. This means data can be monitored by therapists and therapy can be customised. Data collected in treatment sessions can be exported as documents in formats such as Excel and PDF, which can be included in individuals' NHS electronic records.
Current NHS pathway
NICE's guideline on spinal injury covers early management in pre‑hospital settings (including ambulance services), emergency departments and major trauma centres but does not cover rehabilitation. The British Society of Rehabilitation Medicine guideline on chronic spinal cord injury also does not include rehabilitation.
NICE's interventional procedures guidance on functional electrical stimulation for drop foot of central neurological origin supports the use of FES for drop foots from conditions such as stroke, cerebral palsy, multiple sclerosis or spinal cord injury provided that normal arrangements are in place for clinical governance, consent and audit.
The current standard care after a spinal cord injury involves acute care after the injury, rehabilitation and reintegration into the community, lifelong follow-up of people living with spinal cord injury, and further admission if necessary for medical or surgical management (NHS England 2013). Rehabilitation following spinal cord injury starts as soon as the patient is medically stable after injury, and focuses on increasing functional independence (Harvey 2016). A range of rehabilitation measures can be used to improve function or compensate for loss of function, such as exercise (WHO 2013).
NICE is aware of the following CE‑marked FES-assisted cycling systems that appear to fulfil a similar function to RT300:
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Rehamove: FES cycling system for weakened or paralysed arms or legs
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BerkelBike: FES-assisted outdoor leg cycling.
Population, setting and intended user
RT300 would be used in a rehabilitation setting with standard rehabilitation care for adults or children with weakened or paralysed muscles in their arms or legs because of spinal cord injury. The technology can also be used in the home.
A trained therapist would set up the RT300 system after a complete assessment of the patient. The therapy could then be given by a therapy assistant or carer at home. Physiotherapists would need training to use RT300.
Costs
Technology costs
Table 1 Cost of RT300
|
Description |
Cost 1 |
|
RT300 leg cycle (6 channels) |
£14,995 (ex VAT) |
|
RT300 leg and arm cycle (6 channels) |
£21,995 (ex VAT) |
|
Additional 6 channels |
£6,995 (ex VAT) |
|
Delivery, installation and clinical follow-up |
£495 (ex VAT) |
|
RT300 service charge |
£495 annually |
|
Electrodes2 |
£528 annually |
|
1The technology has an 8 year lifespan. The cost may vary depending on the number of channels available. 2The cost is based on a single patient using the RT300 3 times per week for 1 year. |
|
Costs of standard care
No estimate for the complete cost of rehabilitation care for people with spinal cord injuries could be identified. One expert noted the cost of other passive FES equipment varied from £50 to £3,500. The number of rehabilitation (physiotherapy) sessions during which treatment with RT300 would be used varies between patients. The estimated cost of a hospital physiotherapist is £32 per hour.
Resource consequences
The company states that 7 of the 12 UK specialist spinal cord injury units offer RT300 as part of standard care, particularly for people with incomplete spinal cord injuries.
If used more widely, it is not expected that RT300 would lead to any major changes in infrastructure, but extra physiotherapy services (such as staff) may be needed.
Using RT300 may help strengthen muscles and improve patient mobility, so it could reduce subsequent resource use and costs in NHS and social care settings. However, there is no evidence to support this, and variability in the standard care pathway and uncertainty in the population who may benefit mean the resource impact is uncertain.