NICE has developed a medtech innovation briefing (MIB) on the ODFS Pace and Pace XL functional electrical stimulation devices for treating drop foot.
The Odstock Dropped Foot Stimulator (ODFS) Pace and Pace XL devices are functional electrical stimulators indicated for treating drop foot relating to neurological conditions. They can be used as an alternative or adjunct to orthotic devices or other walking aids, or to provide a longer term therapeutic effect. Relevant evidence includes 3 randomised control trials (RCTs; 5 papers), and 1 case series. In people with multiple sclerosis, 1 RCT reported a significant improvement in activities of daily living and a reduction in the number of falls compared with exercise therapy, whereas the other reported an improved walking performance while using the device but no benefit once people stopped using it. A case series found significant improvements in outcome measures for assisted walking (with the ODFS device) compared with unassisted walking.
Three papers reported studies involving people with a history of stroke. Two of the papers from a single trial reported no significant difference in training effect outcomes between the ODFS and standard care (physical therapy) groups. A further paper reported a significant improvement in walking speed with the ODFS compared with standard care (physiotherapy), but a non-significant improvement in physiological cost index (effort involved in walking) and no lasting effect without the device.
The ODFS Pace and Pace XL stimulators cost £670 and £995 respectively (excluding VAT), and are used for an average of 5 years. The total treatment costs are £3,320 and £4,325 per patient over 5 years respectively, including consumables. All costs are excluding VAT.
MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.