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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 lesions4, 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 physiotherapy11, 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 years17,18,19.

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 bradikinesia13, 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 3rd 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. 10th 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? 9th Annual Conference of the International FES Society and 2nd 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
Resources +

Introduction to FES, the Clinical Service and referral criteria

YouTube channel

Knowledge Base

Refence list dropped foot stimulation

The Case for the Odstock Dropped Foot Stimulator Dec 2022

The Case for FES +

The Case for FES

A more in-depth document which is a summary of the published evidence for using the ODFS. (OML FES equipment).

A summary of the published evidence for using the ODFS.  The article summarises the Randomised Controlled Trials (RCT’s), case series and economic evaluations (QALY and cost benefit) for using the ODFS for correction of drop foot.  It also includes a comprehensive research reference list. Click here.
Current Research +

Tetragrip

OML is working with partners at Bournemouth and Southampton Universities to develop a FES system to assist hand function with people who have tetraplegia (a spinal cord injury in the neck).  It is aimed at people who have no or very little movement in their hands.

The system will use an electrode garment to activate the muscles that open and close the hand.  Movements are controlled using a simple movement sensor mounted on the shoulder. The system will allow the user to hold objects such as  a knife or fork, pen and other everyday objects. This project is funded by INSPIRE.

Further information.  Related article 1  Related article 2

Bowman

Lack of bowel control and constipation are common problems following spinal cord injury. Preliminary studies indicate that electrical stimulation of the abdominal muscles can lead to reduced constipation and improved bowel function.  This randomized controlled trial will evaluate the use of the Microstim 2v2 to increase natural bowel activity.72 people with spinal cord lesions at T12 or above will be randomly allocated to a treatment group or a placebos group. Both interventions will be used daily at home for 12 weeks. Further information. This project is funded by INSPIRE.

Smartstim

Adaptive functional electrical stimulation to aid walking for people with neurological dysfunction PhD studentship funded by OML and Bournemouth University
This project aims to develop methods of controlling stimulation parameters so that they can optimized for different walking environments.

Algorithms are being developed to automatically detect the type of walking that is required, for example, walking on smooth surfaces, walking on rough ground, stair climbing or stepping over a curb. A change in walking environment will then course adjustment of stimulation intensity and timing, improving the assistance given.

An investigation into the use in the rehabilitation of osteo arthritis patients who undergo hip replacement surgery

Louise Burges PhD programme funded by Bournemouth University.

This work aims to investigate the use of the Microstim 2v2 Orthopaedic in the training of muscle prior to and following total hip replacement due to OA.  A series of studies have reviewed the use of FES in this condition, examined the acceptability of the technique and aims to demonstrate that training of the quadriceps muscle may improve fatigue resistance.

Review article 1,  review article 2,  study 1,  study 2.

 

 

Recent research +

The Effectiveness of Peroneal Nerve Functional Electrical STimulation (FES) for the Reduction of Bradykinesia in Parkinson’s Disease: A Pragmatic Feasibility Study for a Single Blinded Randomised Control Trial (STEPS).

This Randomised controlled feasibility study was funded by Research for Patient Benefit (RfPB) and took place at Salisbury District Hospital and the National Hospital for neurology and Neurosurgery, London. The project aimed to assess the feasibility of conducting a study into the use of FES to improve the walking of people with Parkinson’s disease. FES was delivered using the ODFS Pace.

64 particiapants were randomised to either a standard care group or an intervention group.  FES was used for 18 weeks. Assessments were made at week 0, 6, 18 and 22 by an assessor blinded to group allocation and were made without FES being used. The study showed that the protocol and  intervention were feasible.  Participants walked faster after FES was used and improvements in activities of daily living were reported.

Summary of the results,  Full results. Participant information Salisbury and London.  Related work

Effect of neuromuscular electrical stimulation on the recovery of people with COVID-19 admitted to the intensive care unit: A narrative review.

This project reviewed the published evidence for how FES can be used to aid the recovery of people who have had Covid-19. FES may have a role in weaning of ventilators, prevention of deep vain thrombosis and muscle re-conditioning. Recommendations for practice and future research are made.

Review article

The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.

This study, funded by the MS society in Scotland, was a randomised controlled trial comparing the ODFS Pace and an ankle foot orthosis over 12 months. The study showed that both devices could improve walking. However, FES gave a bigger improvement in device related quality of life and people stopped using AFOs twice as often as FES. This resulted in greater cost effectiveness for FES than AFOs.

Abstract.   Full results  Related article 1 Related article 2 Related work

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