Pairing Functional Electrical Stimulation (FES) and Volitional Effort Training Promotes Neuroplasticity and Motor Gain

June 8, 2016 updated by: Kessler Foundation
The goal of the study is to explore the effect of combined training involving functional electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke patients. Participants will be assessed for functional motor ability and neurological function during their first visit and then again after five and then ten weeks of training. Functional motor ability is broken down into dorsiflexion strength and general gait analysis. Dorsiflexion strength is measured by use of a dynamometer. Gait is assessed via recordings of electromyography, pedobarography, kinematic, and various functional variables during 10 walking trials. The neurological assessment will include electroencephalographic (EEG) analysis of movement-related cortical potentials (MRCP), somatosensory evoked potentials (SSEP), and M-wave response to stimulation. Participants will be randomly assigned to one of three groups: 1) FES + volitional movement (VOL), 2) FES alone, and 3) VOL alone, which will determine their training regimen. The training sessions involve roughly 20 minutes of repeated muscle contractions (with appropriate breaks to avoid fatigue). The participants assigned to the FES+VOL group will receive electrical stimulation to the peroneal nerve in concert with volitional dorsiflexion, whereas the other groups will either dorsiflex voluntarily with no stimulation or receive stimulation while being asked to do nothing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be hemiplegic secondary to stroke and exhibit foot drop (as diagnosed by the participant's treating physician)
  • Between the ages of 10 and 90.
  • Must have sustained a stroke at least 6 months prior to enrollment.
  • Uninvolved lower limb must have no history of injury or pathology within the last 90 days.
  • Must be able to walk independently for 10 meters.
  • Must have inadequate dorsiflexion during the swing phase of gait resulting in inadequate limb clearance
  • Medically stable for three months prior to the most recent episode of stroke resulting in hemiplegia or hemiparesis with foot drop
  • Adequate cognitive function to give informed consent, understand instructions, and give adequate feedback.

Exclusion Criteria:

  • Individuals with additional orthopedic, neuromuscular, or neurological pathologies that would interfere with their ability to walk
  • Individuals with previous use of FES for community ambulation (neuroprosthesis) or clinical treatment <1 year will be excluded from participation due to possible confounding effects
  • Severe cardiac disease such as myocardial infarction, or congestive heart failure
  • Fixed ankle contractures of ten degrees of plantarflexion with knee extended
  • Pre-existing pathology resulting in a significant disruption in alignment or function of the lower extremity
  • Excessive dysesthetic pain secondary to neurological involvement
  • Severe hypertonicity resulting in the need for more involved rehabilitation strategies
  • Participants will not be excluded due to gender or ethnicity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FES+VOL
Electrical stimulation (FES) in concert with volitional effort. The subject is visually cued to initiate the movement and when they begin the movement (as ascertained by EMG response), the stimulation is immediately applied until the completion of the trial.
Other: FES + VOL
Electrical stimulation is applied in concert with the subject's volitional movement.
Active Comparator: FES
Electrical stimulation alone. The subject is asked to do nothing as electrical stimulation initiates and completes the movement for them.
Other: FES
Electrical stimulation is applied to the subject while they are asked to do nothing.
Active Comparator: VOL
Volitional effort alone. When cued, the subject initiates and completes the movement on their own until the completion of the trial. There is no electrical stimulation in this group.
Other: VOL
The subject initiates and completes the movement without electrical stimulation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Force Produced by Voluntary Dorsiflexion
Time Frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Time to Complete 10 Meter Walk
Time Frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Center of Pressure of Plantar Loading During Walking Trial
Time Frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Joint Angles During Walking Trial
Time Frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Sagittal (flexion and extension), frontal (abduction and adduction) and transverse (internal and external rotation) plane angles of the ankle, knee, and hip.
Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude of the Major Components of Somatosensory Evoked Potentials
Time Frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude of the N1, N2, P1, and P2 components of artifact free epochs
Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude of the P40-N50 Complex During Movement Related Cortical Potentials
Time Frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Amplitude and Latency of M-Wave Component of EMG During Maximal Voluntary Contraction
Time Frame: Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention
Change from baseline to 0 weeks post-intervention and from baseline to 5 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-806-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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