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Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jayme Knutson, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01029912
First received: December 9, 2009
Last updated: December 13, 2011
Last verified: December 2011

December 9, 2009
December 13, 2011
November 2009
August 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029912 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors
Contralaterally Controlled NMES in Chronic Ankle Dorsiflexor Paresis After Stroke

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Hemiparesis
  • Lower Extremity Paresis
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.

  • Experimental: CCNMES
    Contralaterally Controlled Neuromuscular Electrical Stimulation
    Intervention: Device: Electrical stimulator
  • Active Comparator: Cyclic NMES
    Cyclic Neuromuscular Electrical Stimulation
    Intervention: Device: Electrical stimulator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01029912
R21HD061593
No
Jayme Knutson, Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Jayme S. Knutson, PhD Case Western Reserve University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP