Spinal Stimulation and Mobility Devices

August 24, 2026 updated by: Katherine Steele, University of Washington

Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: 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
Device: Mobility Device
Use of mobility device, an ankle exoskeleton, during walking sessions.
Other Names:
  • Biomotum SPARK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Coordination
Time Frame: Co-contraction index during the last minute of a 5-minute walking trial at a single visit.
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.
Co-contraction index during the last minute of a 5-minute walking trial at a single visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale of Spasticity
Time Frame: Physical exam conducted at the beginning and end of each visit.
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.
Physical exam conducted at the beginning and end of each visit.
Plantarflexor Muscle Strength
Time Frame: Physical exam conducted at the beginning and end of each visit.
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.
Physical exam conducted at the beginning and end of each visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Seattle Children's Hospital

Investigators

  • Principal Investigator: Katherine Steele, PHD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Actual)

May 13, 2023

Study Completion (Actual)

May 13, 2023

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)

September 18, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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