Stroke Gait Rehabilitation Using Functional Electrical Stimulation

NCT01668602 | Completed Results FDA Device

• 3 other identifiers: IRB000583635K01HD079584-0213SDG13320000
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. As part of this protocol, 55 individuals with chronic stroke will be assigned to either Cohort 1 or Cohort 2, and will participate in 1-18 gait training sessions. If interested, study participants can also complete both study cohorts sequentially (with at least 3-weeks duration between switching from one cohort to the second). The study examines the effects among two cohorts of post stroke patients. Cohort 1 will participate in 18 sessions of fast treadmill walking plus Functional Electrical Stimulation (FastFES) and Cohort 2 will participate in 1-3 sessions of FastFES and fast walking without FES.

Conditions

Cerebrovascular Accident

Keywords

Rehabilitation; Gait disorders; Chronic stroke

Outcome Measures

Primary Outcomes (4)

• Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2

  Change from baseline in MEP amplitude (transverse abdominal (TA) muscle) 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.

  Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)

• Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2

  Change from baseline 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.

  Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)

• Change in Motor Evoked Potentials (MEP) Amplitude Measure in milliVolt (mV) of FastFES After 18 Training Sessions in Cohort 1

  Change from baseline in MEP amplitude (TA muscle in a resting state) 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.

  Baseline and up to 6 weeks

• Change in H-Reflex /M-Wave (Hmax/Mmax) Ratio Among FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1

  Change from baseline 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.

  Baseline and up to 6 weeks

Secondary Outcomes (2)

• Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 3 Training Sessions in Cohort 2

  Baseline, week 3 (after 3 sessions of one intervention), week 6 (after 3 sessions of the other intervention)

• Change in Peak Anterior Ground Reaction Force (AGRF) of FastFES Versus Fast Walking After 18 Training Sessions in Cohort 1

  Baseline and up to 6 weeks

Study Arms (2)

Cohort 1 - FastFES Training

EXPERIMENTAL

Participants with chronic stroke in Cohort 1 will receive 18 training sessions of FastFES (fast treadmill walking with electrical stimulation).

Device: Fast Walking with Fast Functional Electrical Stimulation (FES) Training

Cohort 2 - FastFES and Fast Walking

EXPERIMENTAL

Participants with chronic stroke in Cohort 2 who complete 3 sessions of FastFES and 3 sessions of fast walking.

Device: Fast Walking with Fast Functional Electrical Stimulation (FES) Training; Other: Fast Walking

Interventions

Fast Walking with Fast Functional Electrical Stimulation (FES) Training DEVICE

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. FastFES gait training sessions may comprise up to six 6-minute bouts of walking with rest breaks between bouts (total 30-minutes of walking). The last training bout (bout 6) may comprise 6-minutes of over ground walking, during which subjects will be asked to walk as fast as they can. For safety, a physical therapist will walk with and guard the subject during over ground walking.

Also known as: FastFES

Cohort 1 - FastFES Training; Cohort 2 - FastFES and Fast Walking

Fast Walking OTHER

Fast walking training sessions will be similar to FastFES in duration, dosage, structure but no FES will be provided.

Cohort 2 - FastFES and Fast Walking

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• American Heart Association: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Allen JL, Ting LH, Kesar TM. Gait Rehabilitation Using Functional Electrical Stimulation Induces Changes in Ankle Muscle Coordination in Stroke Survivors: A Preliminary Study. Front Neurol. 2018 Dec 20;9:1127. doi: 10.3389/fneur.2018.01127. eCollection 2018.

  PMID: 30619077 DERIVED

MeSH Terms

Conditions

Stroke; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Trisha Kesar, PT, PhD
• Organization: Emory University

trisha.m.kesar@emory.edu

404-712-5803

Study Officials

• Trisha Kesar, PT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Assignment to either Cohort 1 or Cohort 2 will occur simultaneously and will be based on the lab/personnel and subject schedules. Participants in Cohort 1 receive only FastFES. Participants in Cohort 2 will receive 3 sessions of FastFES and 3 sessions of fast walking without FES.

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 10, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)