ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Electrical Stimulation for Footdrop in Hemiparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
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

September 2, 2005
September 7, 2005
March 2, 2018
June 1, 2018
June 1, 2018
July 2005
August 2, 2010   (Final data collection date for primary outcome measure)
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).
Fugl-Meyer Assessment(FMA) - Weeks 0, 12, 24, 36
Complete list of historical versions of study NCT00148343 on ClinicalTrials.gov Archive Site
  • Steps Per Minute [ Time Frame: Weeks 0, 12, 24, 36 ]
    The number of steps taken by participants in one minute
  • 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.
  • 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.

  • Gait Speed [ Time Frame: baseline, 12, 24 and 36 weeks ]
  • Quantitative Gait Analysis - 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
  • Electronic Activity Monitor (activPAL) 3 day monitor - weeks 0, 12, 24, 36
  • Optional Quantitative Gait Analysis of Orthotic Effect of ODFS - weeks 6-12
Not Provided
Not Provided
 
Functional Electrical Stimulation for Footdrop in Hemiparesis
Functional Electrical Stimulation for Footdrop in Hemiparesis

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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Hemiplegia
  • 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.
  • 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.
  • Experimental: ODFS
    Odstock Dropped-Foot Stimulator (ODFS)
    Interventions:
    • Device: Odstock Dropped-Foot Stimulator (ODFS)
    • Procedure: Traditional Physical Therapy Treatment
  • 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]
    Interventions:
    • Other: Conventional Standard of Care
    • Procedure: Traditional Physical Therapy Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
170
August 2, 2010
August 2, 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00148343
IRB04-00104
R01HD044816 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Plan to Share IPD: No
John Chae, MD, MetroHealth Medical Center
MetroHealth Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Case Western Reserve University
Principal Investigator: John Chae, MD MetroHealth Medical Center
MetroHealth Medical Center
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP