Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to describe the effect of neuromuscular electrical stimulation (NMES) in the form of functional electrical stimulation (FES) applied to different lower limb muscles on reactive balance and gait performance in stroke participants. Methods: Twenty individuals with chronic stroke will be asked to perform an experimental protocol that includes a postural disturbance in the form of a slip- or trip-like perturbation and a standardized walking test in both laboratory and outdoor environments with and without FES applied to different lower limb muscles of the paretic leg. FES will be applied using an advanced software that is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. This project design aims to examine whether a specific pattern of lower limb muscle stimulation could improve the kinematic and behavioral responses during reactive balance following slip- and trip-like perturbations. Additionally, the project aims to see if the kinematic and spatio-temporal gait parameters can be modified during a standardized walking test under different sensory and environmental conditions.

Clinical Trial Description

Functional impairment after a stroke often includes slowed gait velocity and increased fall risk attributed to foot drop (the inability to dorsiflex the ankle during the swing phase of gait) and lower limb muscle weakness. Damage in the motor cortex or corticospinal tract often results in significant, persistent distal muscle weakness, including the sensorimotor control of the ankle joint, typically because of a combination of weakness of the agonist ankle dorsiflexor muscles and spasticity of the antagonist plantar flexor muscle. This results in slower and abnormal gait which leads to gait compensation strategies such as hip hitching, excess circumduction during gait, reduced foot clearance, and high energy expenditure, all of which are factors which could increase the risk of falls in individuals with stroke. Functional electrical stimulation (FES) corresponds to the application of an electric field across the motor neurons of a muscle to induce an artificial, involuntary contraction to perform a functional movement. Numerous benefits of FES have been reported throughout literature such as increased muscle mass, increased bone mineral density, and improved cardiovascular parameters, among others. Previous studies in which authors assessed the effect of FES on individuals with stroke have demonstrated that the common peroneal nerve stimulates the tibialis anterior muscle to produce foot dorsiflexion during the swing phase of the gait cycle and reduces foot drop by facilitating increased voluntary muscle activity, which together improves the quality and symmetry of gait. Additionally, others studies showed that FES improves walking speed and energy expenditure in individuals with stroke. In the last years, FES systems have been used as neuroprosthetic devices in rehabilitative interventions such as gait training. Stimulator triggers, implemented to control stimulation delivery, range from open- to closed-loop controllers.12 Finite-state controllers trigger stimulators when specific conditions are met and utilize preset sequences of stimulation. Thus, wearable sensors provide the necessary input to differentiate gait phases during walking and trigger stimulation to specific muscles.13 This technology has been largely used to improve gait parameters in stroke participants, however, it has not been well described how this technology could help stroke participants during the loss of balance or during reactive balance. On the other hand, the literature suggests that a direct transcortical loop does not trigger the initial phase of postural responses to external perturbations, but it seems likely that the cerebral cortex becomes involved in the later phases of the reactive response.14 Thus, given that postural response lasts for many hundreds of milliseconds, it may be that the brainstem or spinal cord circuits initiate a response, and then the response subsequently becomes modified by cortical circuits during its later phases.15 In this context, the effect of peripheral stimulation to the muscles involved in the reactive response to an unexpected external perturbation on recovery performance has not yet been described. This project aims to describe whether a specific pattern of lower limb muscle stimulation could modify the recovery response after an unexpected perturbation in the form of a slip and/or trip in individuals with stroke. Also, this project aims to examine if a specific pattern of lower limb muscle stimulation provided by FES can modify kinematic and spatio-temporal gait parameters during a standardized walking test under different sensory conditions. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04957355
Study type Interventional
Source University of Illinois at Chicago
Status Active, not recruiting
Phase N/A
Start date May 15, 2021
Completion date December 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT03780296 - Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke N/A
Recruiting NCT03228264 - A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia. N/A
Completed NCT03531567 - Game-Based Home Exercise Programs in Chronic Stroke: A Feasibility Study N/A
Completed NCT02364232 - Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation N/A
Completed NCT04574687 - Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients. N/A
Not yet recruiting NCT05490277 - Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke Phase 1/Phase 2
Recruiting NCT04534556 - Wireless Nerve Stimulation Device To Enhance Recovery After Stroke N/A
Recruiting NCT04974840 - Thera-band Resisted Treadmill Training for Chronic Stroke Patients N/A
Recruiting NCT04553198 - Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery N/A
Completed NCT04226417 - Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke N/A
Active, not recruiting NCT02881736 - Proprioceptive Deficits and Anomalies in Movement-error Processing in Chronic Stroke Patients N/A
Completed NCT03208634 - Rehabilitation Multi Sensory Room for Robot Assisted Functional Movements in Upper-limb Rehabilitation in Chronic Stroke N/A
Recruiting NCT05183100 - Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke N/A
Completed NCT03326349 - Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke N/A
Recruiting NCT04721860 - Optimizing Training in Severe Post-Stroke Walking Impairment N/A
Completed NCT01916486 - Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke N/A
Active, not recruiting NCT05134324 - The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke N/A
Active, not recruiting NCT03947645 - Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients N/A
Completed NCT03752788 - Dual-Task Training With Different Priority Instructional Sets on the Gait Parameters in Patients With Chronic Stroke N/A
Completed NCT05376982 - Comparison of NT Vs Body Weight Supported TT Along With CT on Lower Extremity in Chronic Stroke Patients N/A