Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

October 9, 2017 updated by: Jayme Knutson, MetroHealth Medical Center
This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos) and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • 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 Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

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

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 21 to 75 years
  • Minimum of 2 wks from a first clinical non-hemorrhagic or hemorrhagic stroke
  • Medically stable
  • Unilateral lower extremity hemiparesis
  • Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council scale, while seated
  • NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
  • Full voluntary ROM of the contralateral ankle
  • Skin intact on bilateral lower extremities
  • Able to don the NMES system or caregiver available to assist with device if needed.
  • Able to hear and respond to stimulator auditory cues
  • Able to follow 3-stage commands
  • Able to recall 2 of 3 items after 30 minutes
  • Cognition and communication adequate for safe use of the device based on neurological assessment by physician principal investigator

Exclusion Criteria:

  • Severely impaired cognition and communication
  • History of peroneal nerve injury
  • History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis
  • Uncontrolled seizure disorder
  • Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
  • Edema of the paretic lower extremity
  • Absent sensation of paretic lower extremity
  • Evidence of deep venous thrombosis or thromboembolism
  • History of cardiac arrhythmias with hemodynamic instability
  • Cardiac pacemaker or other implanted electronic system
  • Botulinum toxin injections to any lower extremity muscle in the last 3 months
  • Pregnancy
  • Symptomatic peripheral neuropathy
  • Current use of psychoactive medications (except selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants)
  • Acetylcholinesterase inhibitor usage
  • Unstable asthmatic condition
  • Metallic implants (including clips and/or wires)
  • Prosthetic heart valves
  • Cardiac, renal or other stent
  • History of claustrophobia
  • Low visual acuity
  • Body weight or body habitus not compatible to MRI machine
  • Medical, psychological, or social concern identified by the principal investigator or co-investigator which suggests inappropriateness of subject participation

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCNMES
Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.
Device: Contralaterally Controlled Neuromuscular Electrical Stimulation
Active Comparator: Cyclic NMES
Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.
Device: Cyclic Neuromuscular Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lower Extremity Fugl-Meyer Score at End of Treatment
Time Frame: Baseline and End of Treatment (6 weeks)

The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).

Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged.
Baseline and End of Treatment (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 10-Meter Walk Test
Time Frame: Baseline and End of Treatment (6 weeks)
Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.
Baseline and End of Treatment (6 weeks)
Change in Ankle Movement Tracking Error at End of Treatment
Time Frame: Baseline and End of Treatment (6 weeks)

Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.

Lower errors are considered to be better outcomes.

For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement.
Baseline and End of Treatment (6 weeks)
Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment
Time Frame: Baseline and End of Treatment (6 weeks)

The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.

Lower times are considered to be a better outcome.

For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged.
Baseline and End of Treatment (6 weeks)

Collaborators and Investigators

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

Sponsor

MetroHealth Medical Center

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University

Investigators

  • Principal Investigator: Lynne R. Sheffler, MD, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

May 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23HD060689 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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