Advice

Summary

Summary

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.

Product summary and likely place in therapy

  • The Odstock Dropped Foot Stimulator (ODFS) Pace and Pace XL are portable functional electrical stimulation (FES) devices, which are used to help people with drop foot walk.

  • The ODFS devices are used as part of an integrated rehabilitation system as an alternative, or in addition to, a foot orthosis or other walking aid for everyday use, or as a therapeutic intervention during physiotherapy sessions.

Effectiveness and safety

  • The evidence in this briefing is of mixed quality and comes from 6 reports including a total of 545 patients.

  • Two papers (from a single trial) reported different outcome measures for people with multiple sclerosis. One paper (n=53) reported a significant improvement in activities of daily living and a reduction in the number of falls for people in the intervention group compared with exercise therapy, whereas the other reported an improved walking performance while using the device but no benefit once people stopped using it (n=44).

  • Two of the papers, from a single trial on people with a history of stroke, reported no significant difference in training effect outcomes between the ODFS and standard care (physical therapy) groups (n=84 in both papers).

  • One further paper on people with a history of stroke reported a significant improvement in walking speed with the ODFS compared with standard care (physiotherapy), but a non‑significant improvement in physiological cost index (a measure of the effort involved in walking) and no training effect (after stopping use of the device; n=32).

  • One case series on people with multiple sclerosis reported significant improvements in assisted walking with the ODFS device compared with unassisted walking (n=153).

Technical and patient factors

  • The devices consist of a stimulator, self‑adhesive electrodes that attach to the leg and a footswitch, which is placed under the foot in the user's shoe.

  • As a user walks, a change in pressure on the footswitch activates the stimulator to apply a small electrical pulse via the electrodes. This causes the leg muscles to contract, which lifts the foot and stabilises the ankle. This aids walking in people with drop foot.

  • ODFS may have an orthotic or therapeutic effect, which is the impact on the user's ability to walk with and without the device respectively.

Cost and resource use

  • The ODFS Pace and Pace XL stimulators cost £670 and £995 respectively, excluding VAT.

  • Per patient costs are determined by tariff payments, which cover all equipment, consumables and staff time costs. At the National Clinical FES Centre, first appointments cost £140, with each subsequent appointment costing £300.

  • Total treatment costs over 5 years are estimated to be £3,320 and £4,325 for the Pace and Pace XL devices respectively. All costs are excluding VAT.