Spinal Stimulation and Mobility Devices

N/ACompletedNCT05520359

University of Washington10 enrolled

Overview

This research study will combine non-invasive spinal stimulation with an ankle exoskeleton to examine the acute impact of the stimulation on gait in children with cerebral palsy.

For people with neurological conditions, excessive and inappropriate muscle activity resulting from injured sensory pathways (e.g., spasticity or hypertonicity) contributes to inefficient movement, bone deformities, pain, and other comorbidities. Research with humans and animals have highlighted the critical importance of both motor and sensory pathways for motor learning after neurologic injury. However, the best techniques for engaging motor and sensory pathways in a way that brings high quality mobility are not well understood. With this study we will examinee how increased sensory feedback, through electrical spinal stimulation, impact movement mechanics in people with cerebral palsy while using an ankle exoskeleton to inform long-term studies and eventual implementation into clinical practice. Mobility devices like ankle exoskeletons offer a promising approach to improve mobility rehabilitation through engagement of sensory and motor pathways. These devices can either assist in movement by providing support to perform an activity or they can be used to provide resistance to build strength. Mechanistically how these devices impact movement mechanics is still not well understood. Electrical spinal stimulation with intensive, repetitive training has demonstrated exciting potential to improve limb function after neurologic injury. Spinal stimulation has shown to improve motor function with long-term training. Stimulation is hypothesized to improve motor pathways through boosting sensory input. However, the neuromechanical effects of stimulation as a result of increased sensory feedback over an acute time frame has not been explored in efforts to test this hypothesis. This study aims to evaluate the acute effects of increased afferent feedback in individuals with neurological conditions via mobility devices and spinal stimulation. Understanding how these approaches affect the quantity and quality of movement in the short term is a first step before determining potential treatment outcomes. In this research, we will quantify the neuromechanics of movement with and without spinal stimulation for individuals with cerebral palsy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cerebral Palsy Stroke Premature Birth Hypoxic-Ischemic Encephalopathy Periventricular Leukomalacia

Interventions

Mobility DeviceDEVICE

Use of mobility device, an ankle exoskeleton, during walking sessions.

Spinal StimulationDEVICE

A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum

Eligibility

Sex: ALLMin age: 4 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * have a neurologic condition * are 4-70 years of age * have stable medical condition * can perform simple cued motor tasks and who can follow 2-3 step commands * who are volunteering to be involved in this study * can provide feedback on comfort and experience during lab visits Exclusion Criteria: * have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation. * have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention * have a history of uncontrolled seizures * have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities * are dependent on ventilation support * have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump) * have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months * have established osteoporosis and taking medication for osteoporosis treatment. * have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.) * have active cancer

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

Muscle Coordination

Level of co-contraction between the ankle plantarflexor and tibialis anterior muscles during gait monitored from electromyography recordings on the more-affected limb during the final minute of the walking trial.

Time frame: Co-contraction index during the last minute of a 5-minute walking trial at a single visit.

Secondary Outcomes

Modified Ashworth Scale of Spasticity

Change in summed score of spasticity from the gastrocnemius and soleus muscles on the more affected limb after completing the walking trial. Lower values indicate greater reductions in spasticity after trial. The maximum score on the Modified Ashworth Scale is a 5, indicating excessive spasticity and rigidity. The minimum score is 0 indicating normal muscle tone. This outcome measure sums the two ankle plantarflexor muscles on the more affected limb, including the gastrocnemius and soleus muscles, resulting in a maximum score of 10 and minimum score of 0 at a given time point.

Time frame: Physical exam conducted at the beginning and end of each visit.

Plantarflexor Muscle Strength

Change in maximum voluntary contraction level of the plantarflexor muscles in the more affect limb taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement comparing trial with mobility device and spinal stimulation to mobility device alone. Lower values indicate greater reduction in strength after trial with mobility device and spinal stimulation versus mobility device alone.

Time frame: Physical exam conducted at the beginning and end of each visit.

Data from ClinicalTrials.gov

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