Effect of FES Interventions on Gait Dynamics in Stroke Population

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Kessler Foundation
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rakesh Pilkar, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT01952613
First received: September 24, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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 Intervention
Stroke
Foot Drop
Device: FES

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Responders to the FES Interventions in Stroke Population

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Gait Symmetry [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    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:
  • Surface Electromyogram (EMG) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    EMG activation timing and amplitudes


Estimated Enrollment: 10
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ten subjects between the ages of 18 and 75 with hemiplegia and drop foot secondary to chronic stroke will be recruited for this study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952613

Contacts
Contact: Kate Goworek 973-324-3560 kgoworek@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Not yet recruiting
West Orange, New Jersey, United States, 07052
Contact: Kate Goworek    973-324-3560    kgoworek@kesslerfoundation.org   
Contact: Rakesh Pilkar, PhD    973-243-6838    rpilkar@kesslerfoundation.org   
Principal Investigator: Rakesh Pilkar, PhD         
Sub-Investigator: Karen J Nolan, PhD         
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Kathleen Goworek, BS    973-324-3560    kgoworek@kesslerfoundation.org   
Contact: Rakesh Pilkar, PhD    973-243-6838    rpilkar@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Rakesh Pilkar, PhD Kessler Foundation
  More Information

No publications provided

Responsible Party: Rakesh Pilkar, Postdoctoral Fellow, Kessler Foundation
ClinicalTrials.gov Identifier: NCT01952613     History of Changes
Other Study ID Numbers: Kessler-RP-R03-1, 1R03NS082950-01
Study First Received: September 24, 2013
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
Foot drop
Functional Electrical Stimulation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014