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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: November 6, 2017
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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Information provided by (Responsible Party):
Jayme Knutson, MetroHealth Medical Center
  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
Stroke Hemiparesis Lower Extremity Paresis Device: Electrical stimulator

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, MetroHealth Medical Center:

Primary Outcome Measures:
  • Change in Lower Extremity Fugl-Meyer Score at End of Treatment [ Time Frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks. ]

    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.


  • Change in Gait Velocity (cm/Sec) at End of Treatment [ Time Frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks. ]
    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.

  • Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP). [ Time Frame: 2 timepoints: Prior to treatment, and End of treatment at 6 weeks. ]

    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.



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 (CCNMES) Electrical Stimulator
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 (NMES) Electrical Stimulator
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. 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.

  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 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
  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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Investigators
Principal Investigator: Jayme S. Knutson, PhD Case Western Reserve University
  More Information

Additional Information:
Publications:

Responsible Party: Jayme Knutson, Assistant Professor, Physical Medicine and Rehabilitation, MetroHealth Medical Center
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
Results First Submitted: September 8, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Jayme Knutson, MetroHealth Medical Center:
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