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Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029912
First Posted: December 10, 2009
Last Update Posted: October 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Case Western Reserve University
Information provided by (Responsible Party):
Jayme Knutson, Case Western Reserve University
  Purpose
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.

Condition Intervention Phase
Stroke Hemiparesis Lower Extremity Paresis Device: Electrical stimulator Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contralaterally Controlled NMES in Chronic Ankle Dorsiflexor Paresis After Stroke

Resource links provided by NLM:


Further study details as provided by Jayme Knutson, Case Western Reserve University:

Primary Outcome Measures:
  • Active Range of Motion of Ankle. Maximum voluntary ankle dorsiflexion angle will be measured using an electrogoniometer. Three ankle dorsiflexion trials will be averaged. [ Time Frame: Pre-treatment, End of treatment, 4-wks & 12-wks Post-treatment. ]

Secondary Outcome Measures:
  • Ankle Movement Tracking Error. The subject's task is to try to keep a computer cursor on or as close to a scrolling trace as possible by voluntarily dorsiflexing the ankle. Three to six trials will be administered after a practice trial. [ Time Frame: Pre-treatment, End of treatment, 4-wks & 12-wks Post-treatment. ]
  • Maximum Voluntary Ankle Dorsiflexion Isometric Moment. Isometric ankle dorsiflexion moment will be measured. Three isometric moment trials will be averaged. [ Time Frame: Pre-treatment, End of treatment, 4-wks & 12-wks Post-treatment. ]
  • Fugl-Meyer Lower Extremity Motor Assessment. In the lower limb motor impairment component of the Fugl-Meyer Assessment (FMA), the subject is asked to make various isolated and simultaneous movements of the hip, knee, and ankle. [ Time Frame: Pre-treatment, End of treatment, 4-wks & 12-wks Post-treatment. ]
  • Quantitative Gait Analysis. Gait kinematics and spatio-temporal gait parameters will be assessed using a motion capture and analysis system. [ Time Frame: Pre-treatment, End of treatment, 4-wks & 12-wks Post-treatment. ]
  • Modified Emory Functional Ambulation Profile (MEFAP). The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains. [ Time Frame: Pre-treatment, End of treatment, 4-wks & 12-wks Post-treatment. ]
  • Questionnaire. A questionnaire will be administered to assess the participants' impression of the intervention's dose and ease of using the device, as well as of their ability to dorsiflex their ankle and of any effect on their walking. [ Time Frame: Pre-treatment, End of treatment, 4-wks & 12-wks Post-treatment. ]

Enrollment: 26
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CCNMES
Contralaterally Controlled Neuromuscular Electrical Stimulation
Device: Electrical stimulator

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.

Active Comparator: Cyclic NMES
Cyclic Neuromuscular Electrical Stimulation
Device: Electrical stimulator

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.


Detailed Description:

Ankle dorsiflexor weakness results in inefficient and unstable gait. While routine physical therapy is beneficial, for many individuals it remains limited in its effectiveness, and consequently many stroke survivors have difficulty walking safely or remain non-ambulatory. Ankle-foot-orthoses (AFOs) are often prescribed to provide ankle stability, but because they limit ankle mobility they may actually inhibit recovery of dorsiflexion. Advanced rehabilitation techniques that emphasize active, repetitive, goal-oriented movement of the impaired limb have produced measurable functional improvements, yet a significant degree of lower extremity disability often remains. In addition, some of these emerging therapies are difficult to administer and are applicable only to patients who retain at least some degree of ambulation. Thus, there is a need for alternative treatments.

This is an exploratory study of an innovative neuromuscular electrical stimulation (NMES) treatment for restoring lower extremity motor control following stroke. We will investigate whether stroke survivors with chronic footdrop recover voluntary ankle dorsiflexion after a novel treatment of NMES. Surface electrodes will deliver stimulation to dorsiflex the ankle with an intensity that is proportional to the amount of dorsiflexion of the other unimpaired ankle. Thus, voluntary dorsiflexion of the unaffected ankle produces stimulated dorsiflexion of the affected ankle. We refer to this stimulation paradigm as Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES). In contrast to existing peroneal nerve stimulators, CCNMES is not intended to be used to assist ambulation; rather it is intended as solely a motor retraining paradigm that may reduce lower extremity impairment and improve ambulation. The primary objective of the proposed study is to obtain pilot data so that an estimate can be made of the efficacy of CCNMES in reducing lower extremity impairment and improving ambulation.

Twenty-six chronic stroke survivors (>6 months post-stroke) will be randomized to either CCNMES or cyclic NMES, an intervention that provides electrical stimulation of the ankle dorsiflexors, but with preprogrammed timing and intensity. For both groups, the treatment will last 6 weeks followed by a 3-month follow-up period. Assessments of ankle impairment and ambulation will be made at baseline, post-treatment, and 1-month and 3-months post-treatment.

This study is the first randomized controlled trial of CCNMES for restoring ankle dorsiflexion in patients with chronic hemiplegia.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 MRC scale, while seated
  • Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an AFO.
  • AFO is clinically indicated (footdrop during ambulation or inefficient gait patterns)
  • 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

Exclusion Criteria:

  • Brainstem stroke
  • Severely impaired cognition and communication
  • History of peroneal nerve injury
  • History of Parkinson's, SCI, TBI, 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029912


Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
National Institutes of Health (NIH)
Case Western Reserve University
Investigators
Principal Investigator: Jayme S. Knutson, PhD Case Western Reserve University
  More Information

Additional Information:
Publications:
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.
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. Erratum in: JAMA. 2004 Nov 24;292(20):2470.
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.
Rushton DN. Functional electrical stimulation and rehabilitation--an hypothesis. Med Eng Phys. 2003 Jan;25(1):75-8.
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. Epub 2005 Feb 9.
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.
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.
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.

Responsible Party: Jayme Knutson, Assistant Professor, Physical Medicine and Rehabilitation, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01029912     History of Changes
Other Study ID Numbers: R21HD061593 ( U.S. NIH Grant/Contract )
First Submitted: December 9, 2009
First Posted: December 10, 2009
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jayme Knutson, Case Western Reserve University:
Stroke
Hemiplegia
Footdrop
Electrical Stimulation
Motor Relearning
Neuroplasticity

Additional relevant MeSH terms:
Stroke
Paresis
Muscle Weakness
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes


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