Research/Evidence

FES is recognised and approved by the National Institute for Health and Care Excellence (NICE). More information on this can be found by clicking here

Clinical Evidence:

Evidence for the correction of Dropped foot using the ODFS Pace

The Odstock Dropped Foot Stimulator (ODFS) Pace was developed at Salisbury District Hospital under funding from the Department of Health.

The Device was evaluated for dropped foot in chronic stroke in a randomised controlled trial (RCT)^{1, 2}.  Additional case series data was collected from patients with MS and incomplete spinal cord injury³ .  The trial demonstrated:

• Increased walking speed when the ODFS Pace is used
• Reduced walking effort
• Reduced spasticity
• Increased quality of life
• Significant cost utility gain (QALY analysis)

The clinical service modal and evidence for the ODFS Pace were presented to the NHS who subsequently recommended the treatment for patients with dropped foot due to upper motor neurone lesions^{4, 5}  .

Audit of the clinical service confirms the results of the RCT and demonstrates a training effect from using the ODFS and a high level of treatment adherence (86% at one year)^{6, 7, 8, 9}. The main reasons patients choose to continue to use the ODFS are:¹⁰

• Reduced effort of walking
• Increased confidence when walking
• Reduced trips and falls

An RCT of the use of the device with secondary progressive MS demonstrated increased walking speed with the device, 72% reduction in falls and a significant positive impact on activities of daily living in comparison to a group that received physiotherapy^{11, 12}.

An audit of 186 users of the ODFS Pace who had MS showed that FES improves functional ambulation category¹⁵.

The ODFS Pace has been demonstrated to be a clinically and cost effective long term assistive device with an average use of 5 years and to extend mobility in MS by 4 years^17,18,19.

Studies using the ODFS Pace with people who exhibited freezing of gait due to Parkinson’s disease indicated that the device may have a significant training effect, reducing bradikinesia^{13, 20}.

Use of the ODFS was recommended in the Royal College of Physicians Clinical Guidelines on Stroke¹⁴.

In excess of 7000 patients have received treatment for dropped foot using FES in Salisbury since the service began. Over 20,000 have received treatment elsewhere in the UK.

FES is recommended in the NICE guidelines IPG278¹⁶.

References

1. Burridge JH, Taylor PN, Hagan SA, Wood DE, Swain ID. The effect of common peroneal nerve stimulation on quadriceps spasticity in hemiplegia. Physiotherapy, 83(2): 82‑89, 1997.
2. Burridge J, Taylor P, Hagan S, Wood D, Swain I. (1997) The effects of common peroneal nerve stimulation on the effort and speed of walking: A randomised controlled clinical trial with chronic hemiplegic patients. Clin Rehabil 201-210.
3. Burridge JH, Taylor PN, Hagan SA, Swain ID. Experience of the clinical use of the Odstock Drop Foot Stimulator. Artificial Organs 21(3): 254‑260, 1997
4. Swain ID, Taylor PN, Burridge JH, Hagan SA, Wood DE. Report to the development evaluation committee Common peroneal stimulation for the correction of drop-foot (1996) https://odstockmedical.com/sites/default/files/the_dec_report.pdf
5. Taylor P, Mann G, Jolley C, Swain I. Economic Justification for the Odstock Dropped Foot Stimulator (ODFS).  ISPO meeting 3^rd Nov 2007 https://odstockmedical.com/sites/default/files/cost_benefit_paper_4.pdf
6. Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton C, Swain ID. Clinical use of the Odstock Drop Foot Stimulator ‑ its effect on the speed and effort of walking. Archives of Physical Medicine and Rehabilitation, 80: 1577-1583, 1999.
7. Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton, C, Swain ID. Clinical audit of five years provision of the Odstock Drop Foot Stimulator. Artificial Organs, 23(5): 440-442, 1999.
8. Taylor PN. The use of electrical stimulation for correction of dropped foot in subjects with upper motor neuron lesions. Advances in Clinical Neuroscience and Rehabilitation, 2(1): 16-18, 2002.
9. Swain ID, Taylor PN. The clinical use of functional electrical stimulation in neurological rehabilitation. In: Horizons in Medicine 16 – Updates on major clinical advances. Ed. Franklyn J. Pub. Royal College of Physicians, ISBN 1-86016-233-9, London, pp. 315-322, 2004.
10. Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton, C, Swain ID. Patient perceptions of the Odstock Drop Foot Stimulator. Clinical Rehabilitation, 13: 333-340, 1999.
11. Mann GE, Jolley CJ, Taylor PN. An investigation into the effect of functional electrical stimulation on mobility and quality of life in patients with Multiple Sclerosis. 10^th Annual Conference of the International FES Society, pp. 309-311, Montreal, Canada, July 2005.
12. Esnouf JE, Taylor PN. Does the Canadian Occupational Performance Measure determine if the Odstock Drop Foot Stimulator improves activities of daily living for people with multiple sclerosis? 9^th Annual Conference of the International FES Society and 2^nd FESnet Conference, (ISBN 1-85899-191-9), pp. 267-269, Bournemouth, UK, September 2004.
13. Mann GE, Finn SM, Taylor PN. A Pilot study to investigate the feasibility of electrical stimulation to assist gait in Parkinson’s disease. Neuromodulation,11 (2) 2008
14. Intercollegiate working party for stroke, (2016) National clinical guidelines for stroke London, Royal College of Physicians ISBN 1860 161 200
15. Street TD, Taylor PN, Swain ID. The Effectiveness of Functional Electrical Stimulation on Walking Speed, Functional Walking Category and Clinically Meaningful Changes for People with Multiple Sclerosis. Archives of Physical Medicine.  Volume 96, Issue 4, April 2015, Pages 667–672
16. http://www.nice.org.uk/Guidance/IPG278 Functional electrical stimulation for drop foot of central neurological origin N1733 1P ISBN 84629-846-6 Jan 09 & Treating drop foot using electrical stimulation N1734 1P ISBN 1-84629-847-4 Jan 09
17. Taylor P, Humphreys L, Swain I. A 15 year cost-effectiveness study of the use of FES for the correction of dropped foot in Multiple sclerosis.  Multiple Sclerosis Journal  2014;20:(7) 1001-2
18. Juckes FM, Marceniuk G, Seary C, Stevenson VL A cohort study of functional electrical stimulation in people with multiple sclerosis demonstrating improvements in quality of life and cost-effectiveness. Clin Rehabil. 2019 Apr 10:269215519837326.
19. Renfrew LM, Paul L, McFadyen A, Rafferty D, Moseley O, Lord AC, Bowers R, Mattison P. The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial. Clin Rehabil. 2019 Apr 11:269215519842254. doi: 10.1177/0269215519842254.
20. The Effectiveness of Peroneal Nerve Functional Electrical Simulation for the Reduction of Bradykinesia in Parkinsons Disease A Feasibility Study for a Randomised Control Trial.pdf