Trial record 5 of 32 for:    Foot Drop

Functional Electrical Stimulation for Footdrop in Hemiparesis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Chae, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00148343
First received: September 2, 2005
Last updated: December 22, 2011
Last verified: December 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation for Footdrop in Hemiparesis

Resource links provided by NLM:


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 ]

Enrollment: 110
Study Start Date: July 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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))
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

Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Investigators
Principal Investigator: John Chae, MD MetroHealth Medical Center
  More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Chae, Prof Vice Chair Physical Medicine and Rehabilitation, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00148343     History of Changes
Other Study ID Numbers: R01HD044816
Study First Received: September 2, 2005
Last Updated: December 22, 2011
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

Additional relevant MeSH terms:
Paresis
Hemiplegia
Stroke
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paralysis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014