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Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

Primary Purpose

Stroke, Hemiparesis, Footdrop

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contralaterally Controlled Neuromuscular Electrical Stimulation
Cyclic Neuromuscular Electrical Stimulation
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, hemiplegia, footdrop, electrical stimulation

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CCNMES

Cyclic NMES

Arm Description

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.

Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.

Outcomes

Primary Outcome Measures

Change in Lower Extremity Fugl-Meyer Score at End of Treatment
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.

Secondary Outcome Measures

Change in 10-Meter Walk Test
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.
Change in Ankle Movement Tracking Error at End of Treatment
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.
Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment
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.

Full Information

First Posted
June 23, 2014
Last Updated
October 9, 2017
Sponsor
MetroHealth Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT02199795
Brief Title
Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
Official Title
Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Footdrop
Keywords
stroke, hemiplegia, footdrop, electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCNMES
Arm Type
Experimental
Arm Description
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.
Arm Title
Cyclic NMES
Arm Type
Active Comparator
Arm Description
Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.
Intervention Type
Device
Intervention Name(s)
Contralaterally Controlled Neuromuscular Electrical Stimulation
Intervention Type
Device
Intervention Name(s)
Cyclic Neuromuscular Electrical Stimulation
Primary Outcome Measure Information:
Title
Change in Lower Extremity Fugl-Meyer Score at End of Treatment
Description
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.
Time Frame
Baseline and End of Treatment (6 weeks)
Secondary Outcome Measure Information:
Title
Change in 10-Meter Walk Test
Description
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.
Time Frame
Baseline and End of Treatment (6 weeks)
Title
Change in Ankle Movement Tracking Error at End of Treatment
Description
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.
Time Frame
Baseline and End of Treatment (6 weeks)
Title
Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment
Description
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.
Time Frame
Baseline and End of Treatment (6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne R. Sheffler, MD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23867888
Citation
Knutson JS, Hansen K, Nagy J, Bailey SN, Gunzler DD, Sheffler LR, Chae J. Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia. Am J Phys Med Rehabil. 2013 Aug;92(8):656-65. doi: 10.1097/PHM.0b013e31829b4c16.
Results Reference
background
PubMed Identifier
20531158
Citation
Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7.
Results Reference
background
PubMed Identifier
11988774
Citation
Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807.
Results Reference
background
PubMed Identifier
15385590
Citation
Kawashima N, Nozaki D, Abe MO, Akai M, Nakazawa K. Alternate leg movement amplifies locomotor-like muscle activity in spinal cord injured persons. J Neurophysiol. 2005 Feb;93(2):777-85. doi: 10.1152/jn.00817.2004. Epub 2004 Sep 22.
Results Reference
background
PubMed Identifier
21516330
Citation
Vasudevan EV, Zehr EP. Multi-frequency arm cycling reveals bilateral locomotor coupling to increase movement symmetry. Exp Brain Res. 2011 Jun;211(2):299-312. doi: 10.1007/s00221-011-2687-y. Epub 2011 Apr 23.
Results Reference
background
Links:
URL
http://fescenter.org/index.php
Description
Cleveland Functional Electrical Stimulation Center

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Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

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