Spinal Stimulation and Mobility Devices

NCT ID: NCT05520359

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Neurologic Disorders

Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders.

Group Type: EXPERIMENTAL

Mobility Device

Intervention Type: DEVICE

Use of mobility device during session.

Spinal Stimulation

Intervention Type: DEVICE

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

Interventions

Mobility Device

Use of mobility device during session.

Intervention Type: DEVICE

Spinal Stimulation

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

Intervention Type: DEVICE

Other Intervention Names

Biomotum SPARK; Trexo; Portable Mobility Aid for Children (PUMA, ENLITEN); SpineX

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Katherine Steele

Professor, Mechanical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Steele, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katherine Steele, PHD

Role: CONTACT

kmsteele@uw.edu

206-685-2390

Katie Landwehr, MS

Role: CONTACT

klandweh@uw.edu

937-231-1205

Facility Contacts

Katie Landwehr, MS

Role: primary

klandweh@uw.edu

937-231-1205

Other Identifiers

STUDY00014877

Identifier Type: -

Identifier Source: org_study_id