Pairing Functional Electrical Stimulation (FES) and Volitional Effort Training Promotes Neuroplasticity and Motor Gain

NCT ID: NCT02797886

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30

Brief Summary

The goal of the study is to explore the effect of combined training involving functional electrical stimulation (FES) of the ankle dorsal flexor with simultaneous maximal-effort voluntary contraction of the same muscle to correct or improve foot drop in chronic stroke patients. Participants will be assessed for functional motor ability and neurological function during their first visit and then again after five and then ten weeks of training. Functional motor ability is broken down into dorsiflexion strength and general gait analysis. Dorsiflexion strength is measured by use of a dynamometer. Gait is assessed via recordings of electromyography, pedobarography, kinematic, and various functional variables during 10 walking trials. The neurological assessment will include electroencephalographic (EEG) analysis of movement-related cortical potentials (MRCP), somatosensory evoked potentials (SSEP), and M-wave response to stimulation. Participants will be randomly assigned to one of three groups: 1) FES + volitional movement (VOL), 2) FES alone, and 3) VOL alone, which will determine their training regimen. The training sessions involve roughly 20 minutes of repeated muscle contractions (with appropriate breaks to avoid fatigue). The participants assigned to the FES+VOL group will receive electrical stimulation to the peroneal nerve in concert with volitional dorsiflexion, whereas the other groups will either dorsiflex voluntarily with no stimulation or receive stimulation while being asked to do nothing.

Conditions

Stroke; Drop Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FES+VOL

Electrical stimulation (FES) in concert with volitional effort. The subject is visually cued to initiate the movement and when they begin the movement (as ascertained by EMG response), the stimulation is immediately applied until the completion of the trial.

Group Type: EXPERIMENTAL

FES + VOL

Intervention Type: OTHER

Electrical stimulation is applied in concert with the subject's volitional movement.

FES

Electrical stimulation alone. The subject is asked to do nothing as electrical stimulation initiates and completes the movement for them.

Group Type: ACTIVE_COMPARATOR

FES

Intervention Type: OTHER

Electrical stimulation is applied to the subject while they are asked to do nothing.

VOL

Volitional effort alone. When cued, the subject initiates and completes the movement on their own until the completion of the trial. There is no electrical stimulation in this group.

Group Type: ACTIVE_COMPARATOR

VOL

Intervention Type: OTHER

The subject initiates and completes the movement without electrical stimulation.

Interventions

FES + VOL

Electrical stimulation is applied in concert with the subject's volitional movement.

Intervention Type: OTHER

FES

Electrical stimulation is applied to the subject while they are asked to do nothing.

Intervention Type: OTHER

VOL

The subject initiates and completes the movement without electrical stimulation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Must be hemiplegic secondary to stroke and exhibit foot drop (as diagnosed by the participant's treating physician)
• Between the ages of 10 and 90.
• Must have sustained a stroke at least 6 months prior to enrollment.
• Uninvolved lower limb must have no history of injury or pathology within the last 90 days.
• Must be able to walk independently for 10 meters.
• Must have inadequate dorsiflexion during the swing phase of gait resulting in inadequate limb clearance
• Medically stable for three months prior to the most recent episode of stroke resulting in hemiplegia or hemiparesis with foot drop
• Adequate cognitive function to give informed consent, understand instructions, and give adequate feedback.

Exclusion Criteria

• Individuals with additional orthopedic, neuromuscular, or neurological pathologies that would interfere with their ability to walk
• Individuals with previous use of FES for community ambulation (neuroprosthesis) or clinical treatment <1 year will be excluded from participation due to possible confounding effects
• Severe cardiac disease such as myocardial infarction, or congestive heart failure
• Fixed ankle contractures of ten degrees of plantarflexion with knee extended
• Pre-existing pathology resulting in a significant disruption in alignment or function of the lower extremity
• Excessive dysesthetic pain secondary to neurological involvement
• Severe hypertonicity resulting in the need for more involved rehabilitation strategies
• Participants will not be excluded due to gender or ethnicity.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Greg Ames

Role: CONTACT

games@kesslerfoundation.org

9732436816 ext. 6816

Kate Chervin

Role: CONTACT

kgoworek@kesslerfoundation.org

9733243560 ext. 3560

Other Identifiers

R-806-13

Identifier Type: -

Identifier Source: org_study_id