Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

NCT01029912 | Completed Results

• 1 other identifier: R21HD061593
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of stroke. The purpose of this exploratory study is to compare two different treatments -- Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of ankle movement and better walking after stroke.

Conditions

Stroke; Hemiparesis; Lower Extremity Paresis

Keywords

Stroke; Hemiplegia; Footdrop; Electrical Stimulation; Motor Relearning; Neuroplasticity

Outcome Measures

Primary Outcomes (3)

• 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. 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.

  2 timepoints: Prior to treatment, and End of treatment at 6 weeks.

• Change in Gait Velocity (cm/Sec) at End of Treatment

  Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged.

  2 timepoints: Prior to treatment, and End of treatment at 6 weeks.

• Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).

  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.

  2 timepoints: Prior to treatment, and End of treatment at 6 weeks.

Study Arms (2)

CCNMES

EXPERIMENTAL

Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) Electrical Stimulator

Device: Electrical stimulator

Cyclic NMES

ACTIVE COMPARATOR

Cyclic Neuromuscular Electrical Stimulation (NMES) Electrical Stimulator

Device: Electrical stimulator

Interventions

Electrical stimulator DEVICE

6-week intervention 15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week. Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device.

CCNMES; Cyclic NMES

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 to 80 years
• \>6 months 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 (MRC) scale, while seated
• Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an ankle-foot orthosis (AFO).
• AFO is clinically indicated (footdrop during ambulation or inefficient gait patterns)
• Neuromuscular electrical stimulation (NMES) of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
• Full voluntary dorsiflexion of the contralateral ankle
• Skin intact on hemiparetic lower extremity
• 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

You may not qualify if:

• Brainstem stroke
• 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 affected lower extremity
• Absent sensation of lower leg and foot
• 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
• Currently receiving Physical Therapy for the lower extremity

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (8)

• Nudo RJ, Wise BM, SiFuentes F, Milliken GW. Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science. 1996 Jun 21;272(5269):1791-4. doi: 10.1126/science.272.5269.1791.

  PMID: 8650578 BACKGROUND

• Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853.

  PMID: 15494583 BACKGROUND

• Robbins SM, Houghton PE, Woodbury MG, Brown JL. The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil. 2006 Jun;87(6):853-9. doi: 10.1016/j.apmr.2006.02.026.

  PMID: 16731222 BACKGROUND

• Rushton DN. Functional electrical stimulation and rehabilitation--an hypothesis. Med Eng Phys. 2003 Jan;25(1):75-8. doi: 10.1016/s1350-4533(02)00040-1.

  PMID: 12485788 BACKGROUND

• Khaslavskaia S, Sinkjaer T. Motor cortex excitability following repetitive electrical stimulation of the common peroneal nerve depends on the voluntary drive. Exp Brain Res. 2005 May;162(4):497-502. doi: 10.1007/s00221-004-2153-1. Epub 2005 Feb 9.

  PMID: 15702321 BACKGROUND

• Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003.

  PMID: 17398254 BACKGROUND

• Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23.

  PMID: 18812432 BACKGROUND

• Sheffler LR, Hennessey MT, Naples GG, Chae J. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair. 2006 Sep;20(3):355-60. doi: 10.1177/1545968306287925.

  PMID: 16885421 BACKGROUND

Related Links

• Cleveland Functional Electrical Stimulation Center
• The MetroHealth System - Clinical Trials

MeSH Terms

Conditions

Stroke; Paresis; Hemiplegia; Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Dr. Jayme Knutson
• Organization: MetroHealth Medical Center

jsk12@case.edu

2167787342

Study Officials

• Jayme S. Knutson, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: December 9, 2009
• First Posted: December 10, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 7, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)