Functional Electrical Stimulation for Footdrop in Hemiparesis

NCT00148343 | Completed Results

• 2 other identifiers: IRB04-00104R01HD044816
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Hemiplegia

Keywords

hemiplegia; hemiparesis; stroke; foot-drop; electrical stimulation; ankle-foot-orthosis

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Motor Assessment (FMA)

  Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).

  Weeks 0, 12, 24, 36

Secondary Outcomes (4)

• Steps Per Minute

  Weeks 0, 12, 24, 36

• Modified Emory Functional Ambulation Profile(mEFAP)

  Weeks 0, 12, 24, 36

• Stroke-Specific Quality of Life Scale (SS-QOL)

  Weeks 0, 12, 24, 36

• Gait Speed

  baseline, 12, 24 and 36 weeks

Study Arms (2)

ODFS

EXPERIMENTAL

Odstock Dropped-Foot Stimulator (ODFS)

Device: Odstock Dropped-Foot Stimulator (ODFS); Procedure: Traditional Physical Therapy Treatment

Standard of Care (inc. AFO)

ACTIVE COMPARATOR

Conventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) \[Traditional Physical Therapy Treatment\]

Other: Conventional Standard of Care; Procedure: Traditional Physical Therapy Treatment

Interventions

Odstock Dropped-Foot Stimulator (ODFS) DEVICE

Device implementation \& use for \~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.

ODFS

Conventional Standard of Care OTHER

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.

Standard of Care (inc. AFO)

Traditional Physical Therapy Treatment PROCEDURE

Traditional physical therapy treatment for 12 weeks.

ODFS; Standard of Care (inc. AFO)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (33)

• 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. doi: 10.1177/026921559701100303.

  PMID: 9360032 BACKGROUND

• 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. doi: 10.1111/j.1525-1594.1997.tb04662.x.

  PMID: 9148719 BACKGROUND

• 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. doi: 10.1136/jnnp.69.3.353.

  PMID: 10945810 BACKGROUND

• 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. doi: 10.1016/s1350-4533(01)00061-3.

  PMID: 11551819 BACKGROUND

• 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. doi: 10.1016/s0003-9993(99)90333-7.

  PMID: 10597809 BACKGROUND

• 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. doi: 10.1191/026921599677086409.

  PMID: 10498351 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1161/01.str.29.5.975.

  PMID: 9596245 BACKGROUND

• 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. doi: 10.1016/s0003-9993(98)90074-0.

  PMID: 9596400 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• El-Hayek K, Quinn A, Berezovskiy R, Santing J, Harley M, Chae J. Relationship between lower limb motor impairment and ambulation function among chronic stroke survivors. Submitted.

  BACKGROUND

• Teasell RW, Bhogal SK, Foley NC, Speechley MR. Gait retraining post stroke. Top Stroke Rehabil. 2003 Summer;10(2):34-65. doi: 10.1310/UDXE-MJFF-53V2-EAP0.

  PMID: 13680517 BACKGROUND

• Teasell RW, Foley NC, Bhogal SK, Speechley MR. An evidence-based review of stroke rehabilitation. Top Stroke Rehabil. 2003 Spring;10(1):29-58. doi: 10.1310/8YNA-1YHK-YMHB-XTE1.

  PMID: 12970830 BACKGROUND

• International Society for Prosthetics and Orthotics. Consensus Conference on

  BACKGROUND

• 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.

  PMID: 13761879 BACKGROUND

• 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.

  PMID: 1081538 BACKGROUND

• 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.

  PMID: 6741512 BACKGROUND

• 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.

  PMID: 1411357 BACKGROUND

• 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. doi: 10.1007/978-3-7091-6105-0_23.

  PMID: 11974972 BACKGROUND

• 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.

  PMID: 315098 BACKGROUND

• 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. doi: 10.1016/s0003-9993(96)90214-2.

  PMID: 8554468 BACKGROUND

• 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.

  PMID: 1079717 BACKGROUND

• 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.

  PMID: 1084734 BACKGROUND

• Stefancic M, Rebersek M, Merletti R. The therapeutic effects of the Ljublijana functional electrical brace. Eur Medicophys 1976; 12:1-9.

  BACKGROUND

• 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.

  PMID: 302481 BACKGROUND

• Sullivan SB. Stroke. In: Sullivan SB, ed. Physical Rehabilitation: Assessment and Treatment. Philadelphia: F. A. Davis Company, 1994:327-360.

  BACKGROUND

• Verbeke G, Molenbergh G. Linear mixed models for longitudinal data. New York: Springer-Verlag, 2000.

  BACKGROUND

• Harrell FE. Regression modeling strategies. New York: Springer-Verlag, 2001.

  BACKGROUND

• Sheffler LR, Taylor PN, Bailey SN, Gunzler DD, Buurke JH, IJzerman MJ, Chae J. Surface peroneal nerve stimulation in lower limb hemiparesis: effect on quantitative gait parameters. Am J Phys Med Rehabil. 2015 May;94(5):341-57. doi: 10.1097/PHM.0000000000000269.

  PMID: 25802966 DERIVED

• Sheffler LR, Taylor PN, Gunzler DD, Buurke JH, Ijzerman MJ, Chae J. Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis. Arch Phys Med Rehabil. 2013 Jun;94(6):1007-14. doi: 10.1016/j.apmr.2013.01.024. Epub 2013 Feb 8.

  PMID: 23399456 DERIVED

Related Links

• Cleveland FES Center
• The MetroHealth System - Clinical Trials

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis; Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Limitations and Caveats

1. Uneven randomization with respect to dorsiflexion status and mEFAP at baseline. 2. High drop out rate of 30% for the ODFS and 20% for usual care 3. Optimal dose and duration of treatment unknown 4. Activity monitor on ODFS and AFO not reliable

Results Point of Contact

• Title: Lynne Sheffler, MD
• Organization: Case Western Reserve University/MetroHealth Medcial Center

lsheffler@metrohealth.org

216-957-3570

Study Officials

• John Chae, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, Chair Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: July 1, 2005
• Primary Completion: August 2, 2010
• Study Completion: August 2, 2010
• Last Updated: June 1, 2018
• Results First Posted: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)