Spinal Stimulation and Mobility Devices

Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Cerebral Palsy; Premature Birth; Hypoxic-Ischemic Encephalopathy; Periventricular Leukomalacia
• Intervention / Treatment: Device: Mobility Device; Device: Spinal Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Steele, PHD; Phone Number: 206-685-2390; Email: kmsteele@uw.edu
• Study Contact Backup: Name: Katie Landwehr, MS; Phone Number: 937-231-1205; Email: klandweh@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Katie Landwehr, MS; Phone Number: 937-231-1205; Email: klandweh@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurologic Disorders; Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders.	Device: Mobility Device; Use of mobility device during session.; Other Names: Biomotum SPARK; Trexo; Portable Mobility Aid for Children (PUMA, ENLITEN); Device: Spinal Stimulation; A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lum; Other Names: SpineX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Coordination	Change in level of co-contraction between the plantarflexor and tibialis anterior muscles during the gait cycle monitored from electromyography recordings.	Comparing first and last minute of walking on treadmill at each experimental session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	Change in summed score of spasticity from lower-extremity muscles. Lower values indicate less spasticity.	Physical exam conducted at the beginning and end of each experimental session.
Plantarflexor Muscle Strength	Change in maximum voluntary contraction level of the plantarflexor muscles taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement.	Physical exam conducted at the beginning and end of experimental session.

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Seattle Children's Hospital
• Investigators: Principal Investigator: Katherine Steele, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Assistive Technology; Spinal Stimulation; Mobility Aids
• Additional Relevant MeSH Terms: Urogenital Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Infant, Premature, Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Brain Damage, Chronic; Hypoxia, Brain; Hypoxia; Encephalomalacia; Premature Birth; Cerebral Palsy; Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Leukomalacia, Periventricular
• Other Study ID Numbers: STUDY00014877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No