NCT02797886

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 10 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	FES + VOL	Electrical stimulation is applied in concert with the subject's volitional movement.
OTHER	FES	Electrical stimulation is applied to the subject while they are asked to do nothing.
OTHER	VOL	The subject initiates and completes the movement without electrical stimulation.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• First posted: 2016-06-14
• Last updated: 2016-06-14