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Stroke Gait Rehabilitation Using Functional Electrical Stimulation

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ClinicalTrials.gov Identifier: NCT01668602
Recruitment Status : Recruiting
First Posted : August 20, 2012
Last Update Posted : September 19, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
American Heart Association
Information provided by (Responsible Party):
Trisha Kesar, PT, PhD, Emory University

Brief Summary:
The study is a prospective interventional study to assess the changes in corticospinal excitability and spinal reflex excitability of in response to rehabilitative strategies and protocols that are commonly used during physical therapy treatment of gait disorders among post-stroke subjects. The study examines the effects among 2 cohorts of post stroke patients that undergo 2 types of interventions - Fast treadmill walking plus functional Electrical Stimulation (FastFES) and Fast treadmill training (Fast). Cohort 1 complete 3 sessions for each intervention in a randomized crossover design; Cohort 2 complete 18 sessions of FastFES to evaluate longer-term effects of training.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: Functional electrical stimulation (FES) Other: Fast Treadmill Walking Not Applicable

Detailed Description:

Stroke is the number one cause of disability. Difficulty with walking affects most stroke survivors. Walking deficits (e.g. reduced ankle flexion during swing phase, decreased forward propulsion during terminal stance) can cause risks of falls, slow walking speed, increased effort of walking, and difficulties with activities of daily living. Restoration of walking ability can improve quality of life, and is perceived as a major goal of rehabilitation by stroke survivors. Examples of interventions that are used to rehabilitate walking post-stroke are functional electrical stimulation, fast treadmill walking, and bio- feedback. While recent research has focused on comparing the effectiveness of different gait rehabilitation interventions, the neural and biomechanical mechanisms underlying different gait rehabilitation strategies are unknown.

The overall purpose of this protocol is to assess the magnitude and time course of biomechanical and neurophysiologic effects of rehabilitative strategies and protocols that are commonly used during physical therapy treatment of gait disorders post-stroke among 2 cohorts of people post-stroke - Cohort 1 and Cohort 2.

The study is being conducted in 2 phases. The Preliminary study phase involves enrolling 35 healthy young able bodied participants that undergo different gait training sessions using electrical stimulation, walking speed, and biofeedback, or neurophysiologic evaluations comprising measurement of corticospinal excitability and spinal excitability (to understand neurophysiology in neurologically-unimpaired adults). This preliminary study helps to better understand the feasibility and safety of the gait training sessions, and to develop strategies for neurophysiologic evaluations (corticospinal and spinal excitability measures) for post stroke subjects that are involved in next phase of the study. Post-stroke individuals also participated in preliminary neurophysiologic testing.

The interventional study phase involves enrolling 55 post stroke subjects that will be assigned to 2 cohorts. Both cohorts will receive identical training sessions involving FastFES and FES but will differ in the number of training sessions. Subjects in Cohort 1 will receive 3 training sessions with a repeated-measures crossover design, while the subjects in Cohort 2 will receive up to 18 training sessions. For both cohorts, dependent variables will include corticospinal and spinal neurophysiology measures, gait biomechanics, and gait function.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Unblinded Non-randomized
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cortical and Spinal Correlates of Post-stroke Gait Rehabilitation
Study Start Date : August 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Cohort 1
Subjects will receive identical treatment of 3 training sessions with Fast Functional Electrical Stimulation that includes Fast treadmill walking and FES (FastFES) and Fast walking without FES.
Device: Functional electrical stimulation (FES)
Functional electrical stimulation (FES) Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current. The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction. The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle.

Other: Fast Treadmill Walking
Subjects will be trained while walking on a treadmill at speeds that were faster than their self-selected speed in fast treadmill walking

Active Comparator: Cohort 2
Subjects in this group will receive 18 training sessions of Fast Functional Electrical Stimulation (FES) that includes Fast treadmill walking and FES.
Device: Functional electrical stimulation (FES)
Functional electrical stimulation (FES) Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current. The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction. The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle.




Primary Outcome Measures :
  1. Change in Motor evoked potentials (MEP) amplitude measure in milliVolt (mV) of FastFES versus Fast walking after 3 training sessions in Cohort 1 [ Time Frame: Baseline up to 6 weeks ]
    Change in MEP amplitude is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.

  2. Change in H‐reflex /M‐wave (Hmax/Mmax) ratio among FastFES versus Fast walking after 3 training sessions in Cohort 1 [ Time Frame: Baseline up to 6 weeks ]
    Change in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.

  3. Change in Motor evoked potentials (MEP) amplitude measure in milliVolt (mV) of FastFES versus Fast walking after 18 training sessions in Cohort 2 [ Time Frame: Baseline and up to 12 weeks ]
    Change in MEP amplitude is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES versus Fast walking. TMS will be delivered using two Magstim 200 stimulators connected via a BiStim module. An average of 10 TMS-evoked MEP responses will be used to comparing mean peak-to-peak MEP amplitudes in response to suprathreshold TMS delivered to the hotspot.

  4. Change in H‐reflex /M‐wave (Hmax/Mmax) ratio among FastFES versus Fast walking after 18 training sessions in Cohort 2 [ Time Frame: Baseline and up to 12 weeks ]
    Change in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. An electrical stimulation electrode is placed just above the knee, and used as the anode for tibial nerve stimulation. Electrical stimulation is delivered via surface electrodes in a static position to the popliteal fossa. The subject's EMG activity will be recorded while the cathode is moved at the back of the knee to determine the location that provides the best EMG response (H-reflex). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity in milliAmpere(mA) 1-80), 7-10 seconds apart, are delivered to the muscle. Also 5-20 electrical stimulus pulses at intensities are delivered that elicit a percentage of the maximum reflex response.


Secondary Outcome Measures :
  1. Change in Peak anterior ground reaction force (AGRF) of FastFES versus Fast walking after 3 training sessions in Cohort 1 [ Time Frame: Baseline and up to 6 weeks ]
    Peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.

  2. Change in Peak anterior ground reaction force (AGRF) of FastFES versus Fast walking after 18 training sessions in Cohort 2 [ Time Frame: Baseline and up to 12 weeks ]
    Peak AGRF during treadmill walking will be collected using a treadmill instrumented with two force platforms under each belt. Motion analysis data will be collected during 15- to 40-second long dynamic walking trials as subjects walk on a treadmill.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic stroke (>6 months post stroke)
  • First (single) lesion
  • Able to walk with or without the use of a cane or walker
  • Sufficient cardiovascular health and ankle stability to walk for 6 minutes at a self-selected speed without an orthoses
  • Resting heart rate 40-100 beats per minute
  • Resting blood pressure between 90/60-70/90.

Exclusion Criteria:

  • Evidence of moderate/ severe chronic white matter disease or cerebellar stroke on MRI
  • Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
  • Insulin dependent diabetes
  • History of lower extremity joint replacement
  • Score of >1 on question 1b and >0 on question 1c on NIH Stroke Scale
  • Inability to communicate with investigators
  • Neglect/hemianopia, or unexplained dizziness in last 6 months
  • Neurologic conditions other than stroke
  • Orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking
  • Contraindications to transcranial magnetic stimulation (TMS) are: history of seizures, metal implants in the head or face, history of recurring or severe headaches/migraine, headache within the past 24 hours, presence of skull abnormalities or fractures, hemorrhagic stroke, history of dizziness, syncope, nausea, or loss of consciousness in the past 12 months

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): NCT01668602


Contacts
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Contact: Trisha Kesar, PT, PhD 404-712-5803 trisha.m.kesar@emory.edu

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Trisha Kesar, PhD    404-712-5803    trisha.m.kesar@emory.edu   
Principal Investigator: Trisha Kesar, PhD         
Sponsors and Collaborators
Emory University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
American Heart Association
Investigators
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Principal Investigator: Trisha Kesar, PT, PhD Emory University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trisha Kesar, PT, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01668602     History of Changes
Other Study ID Numbers: IRB00058363
5K01HD079584-02 ( U.S. NIH Grant/Contract )
13SDG13320000 ( Other Identifier: American Heart Association )
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Trisha Kesar, PT, PhD, Emory University:
Rehabilitation
Gait disorders

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases