Effect of FES Interventions on Gait Dynamics in Stroke Population

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. Identifier: NCT01952613
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : August 21, 2017
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Rakesh Pilkar, Kessler Foundation

Brief Summary:
Our proposal quantitatively analyzes gait dynamics of hemiplegic individuals in response to the Function Electrical Stimulation (FES) intervention and identifies the responders to the intervention. This study will improve our knowledge of FES intervention and help clinicians strategize the FES interventions more effectively based on the responders' gait characteristics, thus supporting the NINDS' fundamental goal of translating basic and clinical discoveries into better ways to prevent and treat neurological disorders.

Condition or disease Intervention/treatment Phase
Stroke Foot Drop Device: FES Not Applicable

Detailed Description:
Hemiplegia with associated foot drop occurs in 50% of the stroke survivors and frequently impairs an individual's ability to walk. Functional Electrical Stimulation (FES) based neuroprosthetic devices have been developed to correct foot drop. The efficacy of these devices were initially examined by Liberson el al. who demonstrated that electrical stimulations could assist in restoring functional movements in paralyzed limbs. In addition to assistance with foot drop, these devices have showed significant improvements in biomechanical variables such as walking speed, distance, stride length and physiological cost for individuals with stroke. In order to comprehensively understand the effect of electrical stimulations on gait recovery, it is critical to analyze the dynamic aspects of gait and measure gait variability during the functional electrical stimulation intervention. In the proposed investigation, we will determine the 'gait symmetry' of FES assisted walking using bilateral cyclograms of the ankle and knee over a period of 6 months. This novel approach will account for the dynamics and complexity of balance by measuring the deviations of joints from a line of symmetry at every instance of gait cycle and will provide better measure of gait symmetry. Utilization of this outcome measure will allow us to understand the role of electrical stimulation at ankle and how this effect gets translated to the knee and hip joints during walking. The changes in the surface electromyograms (EMGs) of selective muscle groups will demonstrate how FES can contribute to muscle re-training after stroke. We will use advanced signal processing algorithms to remove FES artifact from the EMG signal in order to comprehensively analyze the carry-over effect of the FES intervention. Finally, we will employ Principal Component Analysis (PCA) - an advanced data mining technique to track and quantify the overall gait recovery process of individuals with stroke using pattern classification algorithms. The gait symmetry measure and the EMGs will be statistically classified to see their clear separation at baseline and 6 month intervals. This classification will allow us to identify the individuals who were most responsive to the intervention. This information is critical and will allow researchers and clinicians to re-strategize the rehabilitation process. Such scientific evaluation will provide the base for further development and implementation of FES devices or technologies, thus supporting the NINDS' fundamental goal of translating basic and clinical discoveries into better ways to treat neurological disorders.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification of Responders to the FES Interventions in Stroke Population
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Stroke - FES
Stroke population currently prescribed a FES orthotic device (< week)
Device: FES
In phase 1, five subjects (randomly chosen) will be provided the FES device and instructed to use it for ambulation for the 6 months. At the baseline visit, gait data will be collected from this group. On the 6 month follow up visit, same data collection procedure will be performed and the devices will be collected back from the subjects. After performing quality check on these devices, phase 2 of the data collection will start by providing the devices to the other five subjects and their baseline data will be collected.

Primary Outcome Measures :
  1. Gait Symmetry [ Time Frame: 6 Months ]
    The kinematic data (3D Marker coordinates) obtained from ankle, knee and hip will be used for creating the bilateral cyclograms. The anterior-posterior angles will be plotted on the x-axis and the medial-lateral angles on y-axis. The equation for the gait symmetry will be based on the perpendicular distance of each point (representing the knee (or ankle) position) from the symmetry line and from origin on 2-D cyclogram plot.

Secondary Outcome Measures :
  1. Surface Electromyogram (EMG) [ Time Frame: 6 Months ]
    EMG activation timing and amplitudes

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have sustained a stroke at least 6 months prior to study enrollment
  • Must have hemiplegia with foot drop
  • Must have positive response to peroneal nerve stimulation resulting in adequate dorsiflexion of the ankle
  • No current usage of Functional Electrical Stimulations for the treatment of foot drop
  • No history of injury or pathology to the unaffected limb
  • Must be able to walk independently or with close supervision, for 25 feet without WalkAide or any assistive device

Exclusion Criteria:

  • Orthopedic pathologies or history that will interfere with ambulation or limit the range of motion of the lower limbs
  • Neuromuscular pathologies or history that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
  • Neurological pathologies (e.g., multiple sclerosis)
  • Serious lung or heart conditions that could severely limit their ability to walk
  • Current involvement in any other study that can affect the results of this study
  • Inability or unwillingness to comply with study procedures, follow-up requirements and follow instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01952613

United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Rakesh Pilkar, PhD Kessler Foundation

Responsible Party: Rakesh Pilkar, Research Scientist, Kessler Foundation Identifier: NCT01952613     History of Changes
Other Study ID Numbers: Kessler-RP-R03-1
1R03NS082950-01 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Rakesh Pilkar, Kessler Foundation:
Foot drop
Functional Electrical Stimulation

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases