Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

Stroke Clinical Trial

Official title:

Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199795
• Other study ID #: K23HD060689
• Secondary ID: K23HD060689
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: October 9, 2017
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2017
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Footdrop
• Hemiparesis
• Paresis
• Stroke

Intervention

Device:
• Contralaterally Controlled Neuromuscular Electrical Stimulation

• Cyclic Neuromuscular Electrical Stimulation

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Case Western Reserve University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Epub 2004 Sep 22. — View 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. — View 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. — View Citation

Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and End of Treatment (6 weeks)
Secondary	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.	Baseline and End of Treatment (6 weeks)
Secondary	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.	Baseline and End of Treatment (6 weeks)

External Links

•   Cleveland Functional Electrical Stimulation Center