NCT05520359

Spinal Stimulation and Mobility Devices

Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 4 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.

Detailed description

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 mobility device use and electrical spinal stimulation, impact movement mechanics in people with neurological conditions to inform long-term studies and eventual implementation into clinical practice. Mobility devices 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 these approaches for individuals with neurologic disorders.

Conditions

• Cerebral Palsy
• Stroke
• Premature Birth
• Hypoxic-Ischemic Encephalopathy
• Periventricular Leukomalacia

Interventions

Type	Name	Description
DEVICE	Mobility Device	Use of mobility device during session.
DEVICE	Spinal Stimulation	A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum

Timeline

• Start date: 2022-08-04
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2022-08-29
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study