Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started May 2014
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
November 8, 2017
CompletedNovember 8, 2017
October 1, 2017
9 months
June 23, 2014
September 11, 2017
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and End of Treatment (6 weeks)
Secondary Outcomes (3)
Change in 10-Meter Walk Test
Baseline and End of Treatment (6 weeks)
Change in Ankle Movement Tracking Error at End of Treatment
Baseline and End of Treatment (6 weeks)
Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment
Baseline and End of Treatment (6 weeks)
Study Arms (2)
CCNMES
EXPERIMENTALContralaterally 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 NMES
ACTIVE COMPARATORCyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Related Publications (5)
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.
PMID: 23867888BACKGROUNDKnutson 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.
PMID: 20531158BACKGROUNDSwinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807.
PMID: 11988774BACKGROUNDKawashima 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.
PMID: 15385590BACKGROUNDVasudevan 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.
PMID: 21516330BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jayme Knutson
- Organization
- MetroHealth Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lynne R. Sheffler, MD
MetroHealth Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Physical Medicine and Rehabilitation
Study Record Dates
First Submitted
June 23, 2014
First Posted
July 24, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 8, 2017
Results First Posted
November 8, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share