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Functional Electrical Stimulation for Footdrop in Hemiparesis
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), August 2008
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00148343
  Purpose

The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors.

The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.


Condition Intervention Phase
Stroke
Hemiplegia
 Device: Odstock Dropped-Foot Stimulator (ODFS)
Other: Conventional Standard of Care
Procedure: Traditional Physical Therapy Treatment
 Phase II

MedlinePlus related topics: Foot Health
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Functional Electrical Stimulation for Footdrop in Hemiparesis

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Fugl-Meyer Motor Assessment (FMA) [ Time Frame: Weeks 0, 12, 24, 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantitative Gait Analysis [ Time Frame: Weeks 0, 12, 24, 36 ] [ Designated as safety issue: No ]
  • Modified Emory Functional Ambulation Profile(mEFAP) [ Time Frame: Weeks 0, 12, 24, 36 ] [ Designated as safety issue: No ]
  • Stroke-Specific Quality of Life Scale (SS-QOL) [ Time Frame: Weeks 0, 12, 24, 36 ] [ Designated as safety issue: No ]
  • Electronic Activity Monitor (activPAL) - 3 day monitor [ Time Frame: Weeks 0, 12, 24, 36 ] [ Designated as safety issue: No ]
  • Optional Quantitative Gait Analysis of Orthotic Effect of ODFS vs. AFO [ Time Frame: Once in Weeks 6-12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: July 2005
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Odstock Dropped-Foot Stimulator (ODFS)
Device: Odstock Dropped-Foot Stimulator (ODFS)
Device implementation & use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
Procedure: Traditional Physical Therapy Treatment
Traditional physical therapy treatment for 12 weeks.
2: Active Comparator
Conventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO))
Other: Conventional Standard of Care
Conventional standard of care (which may include implementation & use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.
Procedure: Traditional Physical Therapy Treatment
Traditional physical therapy treatment for 12 weeks.

Detailed Description:

Hemiplegia is a major consequence of stroke and contributes significantly to the physical disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during the swing phase of gait, and ankle instability during stance phase, are important gait abnormalities that contribute to reduced mobility among stroke survivors. In the United States, the standard of care in addressing these deficits is the custom molded ankle-foot-orthosis (AFO). However, evolving data now demonstrate that active repetitive movement training is the principal substrate for facilitating motor relearning after stroke. Motor relearning is defined as the reacquisition of motor ability after central nervous system injury. Thus, while an AFO may assist stroke survivors to ambulate in the short-term, it is possible that it also inhibits recovery in the long-term. Previous studies have demonstrated that active repetitive movement exercises mediated by neuromuscular electrical stimulation (NMES) facilitate motor relearning among stroke survivors. In particular, studies have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for foot-drop experience sufficient recovery that they no longer need the peroneal nerve stimulator or an AFO for community ambulation. However, there are no blinded randomized clinical trials that rigorously evaluate the motor relearning effects of ambulation training with peroneal nerve stimulators. Thus, the primary aim of this project is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb motor relearning among chronic stroke survivors. The secondary aim is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb mobility (disability) and overall quality of life. A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared to ambulation training with conventional standard of care (which may include an AFO). Subjects will be treated for 12 weeks and followed for a total of another 6 months. This project will determine the effectiveness of peroneal nerve stimulation in facilitating motor relearning and improving the mobility and quality of life of stroke survivors. This proposed approach is expected to improve patient outcome and challenge the present clinical paradigm of prescribing AFOs for stroke survivors with foot-drop.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stroke survivors >90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke
  • Age: 18-80 years
  • Unilateral hemiparesis
  • Medically stable
  • Sufficient endurance & motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO
  • Berg Balance Scale score of 24 or greater without any assistive devices
  • Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing
  • Demonstrate foot-drop during ambulation such that gait instability [need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls] or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited
  • Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES
  • If using an AFO, willing to terminate its use and comply with study requirements

Exclusion Criteria:

  • Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
  • Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
  • Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
  • Absent sensation of the affected lower limb
  • History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability
  • Demand pacemakers or any other implanted electronic systems
  • Pregnant women
  • Uncontrolled seizure disorder
  • Parkinson's Disease
  • Spinal cord injury
  • Traumatic brain injury with evidence of motor weakness
  • Multiple sclerosis
  • Fixed ankle plantar flexor contracture
  • Peroneal nerve injury at the fibular head as the cause of foot-drop
  • Uncompensated hemineglect
  • Severely impaired cognition and communication
  • Painful hypersensitivity to NMES of the common peroneal nerve
  • Inadequate social support (potential unlikeliness to comply with treatment & follow-up)
  • History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry
  • Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148343

Contacts
Contact: Cathy Corrigan, RN 216-778-5347 ccorrigan@metrohealth.org
Contact: Peggy Maloney, RN 216-778-5347 mmaloney@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Cathy Corrigan, RN     216-778-5347     ccorrigan@metrohealth.org    
Contact: Peggy Maloney, RN     216-778-5347     mmaloney@metrohealth.org    
Principal Investigator: John Chae, MD            
Sub-Investigator: Lynne Sheffler, MD            
Sub-Investigator: Ron Triolo, PhD            
Sub-Investigator: Cathy Corrigan, RN            
Sub-Investigator: Gregory Naples            
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: John Chae, MD MetroHealth Medical Center
  More Information

Cleveland FES Center  This link exits the ClinicalTrials.gov site
The MetroHealth System - Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:
Burridge JH, Taylor PN, Hagan SA, Wood DE, Swain ID. The effects of common peroneal stimulation on the effort and speed of walking: a randomized controlled trial with chronic hemiplegic patients. Clin Rehabil. 1997 Aug;11(3):201-10.
Burridge J, Taylor P, Hagan S, Swain I. Experience of clinical use of the Odstock dropped foot stimulator. Artif Organs. 1997 Mar;21(3):254-60.
Burridge JH, McLellan DL. Relation between abnormal patterns of muscle activation and response to common peroneal nerve stimulation in hemiplegia. J Neurol Neurosurg Psychiatry. 2000 Sep;69(3):353-61.
Burridge JH, Wood DE, Taylor PN, McLellan DL. Indices to describe different muscle activation patterns, identified during treadmill walking, in people with spastic drop-foot. Med Eng Phys. 2001 Jul;23(6):427-34.
Taylor PN, Burridge JH, Dunkerley AL, Wood DE, Norton JA, Singleton C, Swain ID. Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking. Arch Phys Med Rehabil. 1999 Dec;80(12):1577-83.
Taylor PN, Burridge JH, Dunkerley AL, Lamb A, Wood DE, Norton JA, Swain ID. Patients' perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clin Rehabil. 1999 Oct;13(5):439-46.
Taylor P, Burridge J. Functional Electrical Stimulation - the Odstock Dropped Foot Stimulator. In: Sassoon R, ed. Understanding Stroke: Pardoe Blacker Publishing Ltd, 2002:72-78.
Taylor P. The use of electrical stimulation for correction of dropped foot in subjects with upper motor neuron lesions. Advances in Clinical Neurosciences and Rehabilitation 2002; 2:16-18.
Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9.
Francisco G, Chae J, Chawla H, Kirshblum S, Zorowitz R, Lewis G, Pang S. Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: a randomized pilot study. Arch Phys Med Rehabil. 1998 May;79(5):570-5.
Mann GE, Wright PA, Swain ID. Training effects of electrical stimulation and the conventional ankle foot orthosis in the correction of drop foot following stroke., 1st Annual Conference of FESnet, 2002.
Taylor P, Mann G, Swain I. Does prior use of an Ankle Foot Orthosis (AFO) effect the response to use of the Odstock Dropped Foot Stimulator?, Institute of Physics and Engineering in Medicine (IPEM) Annual Scientific Meeting, Bath, U.K., September 15-17, 2003:89-90.
Buurke JH, Roetenberg D, Kleissen RFM, Hermens HJ. Early recovery of gait after stroke, 3rd World Congress in Neurological Rehabilitation, Venice, Italy, April 2-6, 2002, 2002.
Teasell RW, Bhogal SK, Foley NC, Speechley MR. Gait retraining post stroke. Top Stroke Rehabil. 2003 Summer;10(2):34-65.
Teasell RW, Foley NC, Bhogal SK, Speechley MR. An evidence-based review of stroke rehabilitation. Top Stroke Rehabil. 2003 Spring;10(1):29-58. Review.
LIBERSON WT, HOLMQUEST HJ, SCOT D, DOW M. Functional electrotherapy: stimulation of the peroneal nerve synchronized with the swing phase of the gait of hemiplegic patients. Arch Phys Med Rehabil. 1961 Feb;42:101-5. No abstract available.
Waters RL, McNeal D, Perry J. Experimental correction of footdrop by electrical stimulation of the peroneal nerve. J Bone Joint Surg Am. 1975 Dec;57(8):1047-54.
Waters RL, McNeal DR, Clifford B. Correction of footdrop in stroke patients via surgically implanted peroneal nerve stimulator. Acta Orthop Belg. 1984 Mar-Apr;50(2):285-95. No abstract available.
Kljajic M, Malezic M, Acimovic R, Vavken E, Stanic U, Pangrsic B, Rozman J. Gait evaluation in hemiparetic patients using subcutaneous peroneal electrical stimulation. Scand J Rehabil Med. 1992 Sep;24(3):121-6.
van der Aa HE, Bultstra G, Verloop AJ, Kenney L, Holsheimer J, Nene A, Hermens HJ, Zilvold G, Buschman HP. Application of a dual channel peroneal nerve stimulator in a patient with a "central" drop foot. Acta Neurochir Suppl. 2002;79:105-7.
Merletti R, Andina A, Galante M, Furlan I. Clinical experience of electronic peroneal stimulators in 50 hemiparetic patients. Scand J Rehabil Med. 1979;11(3):111-21.
Granat MH, Maxwell DJ, Ferguson AC, Lees KR, Barbenel JC. Peroneal stimulator; evaluation for the correction of spastic drop foot in hemiplegia. Arch Phys Med Rehabil. 1996 Jan;77(1):19-24.
Takebe K, Kukulka C, Narayan MG, Milner M, Basmajian JV. Peroneal nerve stimulator in rehabilitation of hemiplegic patients. Arch Phys Med Rehabil. 1975 Jun;56(6):237-9.
Takebe K, Basmajian JV. Gait analysis in stroke patients to assess treatments of foot-drop. Arch Phys Med Rehabil. 1976 Jul;57(1):305-10.
Stefancic M, Rebersek M, Merletti R. The therapeutic effects of the Ljublijana functional electrical brace. Eur Medicophys 1976; 12:1-9.
Carnstam B, Larsson LE, Prevec TS. Improvement of gait following functional electrical stimulation. I. Investigations on changes in voluntary strength and proprioceptive reflexes. Scand J Rehabil Med. 1977;9(1):7-13.
Sullivan SB. Stroke. In: Sullivan SB, ed. Physical Rehabilitation: Assessment and Treatment. Philadelphia: F. A. Davis Company, 1994:327-360.
Verbeke G, Molenbergh G. Linear mixed models for longitudinal data. New York: Springer-Verlag, 2000.
Harrell FE. Regression modeling strategies. New York: Springer-Verlag, 2001.

Responsible Party: MetroHealth Medical Center; Case Western Reserve University ( John Chae, MD )
Study ID Numbers: R01HD044816, R01HD044816
Study First Received: September 2, 2005
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00148343  
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
hemiplegia
hemiparesis
stroke
 foot-drop
electrical stimulation
ankle-foot-orthosis

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Hemiplegia
Paresis
Cerebral Infarction
Stroke
 Vascular Diseases
Central Nervous System Diseases
Neurologic Manifestations
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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