Functional Electrical Stimulation for Footdrop in Hemiparesis

• ClinicalTrials.gov Identifier: NCT00148343
• Recruitment Status: Completed
• First Posted: September 7, 2005
• Results First Posted: June 1, 2018
• Last Update Posted: June 1, 2018
• Sponsor: MetroHealth Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Case Western Reserve University
• Information provided by (Responsible Party): John Chae, MD, MetroHealth Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Hemiplegia	Device: Odstock Dropped-Foot Stimulator (ODFS); Other: Conventional Standard of Care; Procedure: Traditional Physical Therapy Treatment	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Functional Electrical Stimulation for Footdrop in Hemiparesis
• Study Start Date: July 2005
• Actual Primary Completion Date: August 2, 2010
• Actual Study Completion Date: August 2, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: ODFS; 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.
Active Comparator: Standard of Care (inc. AFO); 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Fugl-Meyer Motor Assessment (FMA) [ Time Frame: Weeks 0, 12, 24, 36 ]
   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).

Secondary Outcome Measures :

1. Steps Per Minute [ Time Frame: Weeks 0, 12, 24, 36 ]
   The number of steps taken by participants in one minute
2. Modified Emory Functional Ambulation Profile(mEFAP) [ Time Frame: Weeks 0, 12, 24, 36 ]
   The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the "timed up-and-go" test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds.
3. Stroke-Specific Quality of Life Scale (SS-QOL) [ Time Frame: Weeks 0, 12, 24, 36 ]

   The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales.

   Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245.

4. Gait Speed [ Time Frame: baseline, 12, 24 and 36 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Sponsors and Collaborators

MetroHealth Medical Center

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Case Western Reserve University

Investigators

• Principal Investigator: John Chae, MD; MetroHealth Medical Center

More Information

Additional Information:

Cleveland FES Center 

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.

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.

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.

International Society for Prosthetics and Orthotics. Consensus Conference on

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.

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.

Kljajić M, Malezic M, Aćimović 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: John Chae, MD, Prof, Chair Physical Medicine and Rehabilitation, MetroHealth Medical Center
• ClinicalTrials.gov Identifier: NCT00148343
• Other Study ID Numbers: IRB04-00104; R01HD044816 ( U.S. NIH Grant/Contract )
• First Posted: September 7, 2005
• Results First Posted: June 1, 2018
• Last Update Posted: June 1, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by John Chae, MD, MetroHealth Medical Center:

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

Additional relevant MeSH terms:

Hemiplegia; Paresis; Nervous System Diseases; Paralysis; Neurologic Manifestations