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Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

NCT ID: NCT01029912

Last Updated: 2017-12-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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. Assessments of ankle impairment and ambulation will be made at baseline and at end of treatment.

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

Conditions

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Stroke Hemiparesis Lower Extremity Paresis

Keywords

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Stroke Hemiplegia Footdrop Electrical Stimulation Motor Relearning Neuroplasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CCNMES

Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) Electrical Stimulator

Group Type EXPERIMENTAL

Electrical stimulator

Intervention Type 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.

Cyclic NMES

Cyclic Neuromuscular Electrical Stimulation (NMES) Electrical Stimulator

Group Type ACTIVE_COMPARATOR

Electrical stimulator

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jayme Knutson

Assistant Professor, Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jayme S. Knutson, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8650578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15494583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16731222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12485788 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15702321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17398254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18812432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16885421 (View on PubMed)

Related Links

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http://fescenter.org/index.php

Cleveland Functional Electrical Stimulation Center

http://www.metrohealth.org/body.cfm?id=2438

The MetroHealth System - Clinical Trials

Other Identifiers

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R21HD061593

Identifier Type: NIH

Identifier Source: secondary_id

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R21HD061593

Identifier Type: NIH

Identifier Source: org_study_id

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