Spinal Stimulation and Mobility Devices

NCT05520359 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00014877
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Pediatric; Mobility Aids; Assistive Technology; Spinal Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Modified Ashworth Scale of Spasticity

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

• Plantarflexor Muscle Strength

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

Study Arms (1)

Neurologic Disorders

EXPERIMENTAL

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

Device: Mobility Device; Device: Spinal Stimulation

Interventions

Mobility Device DEVICE

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

Also known as: Biomotum SPARK

Neurologic Disorders

Spinal Stimulation DEVICE

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

Also known as: SpineX

Neurologic Disorders

Eligibility Criteria

• Age: 4 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Seattle Children's Hospital: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Stroke; Premature Birth; Hypoxia-Ischemia, Brain; Leukomalacia, Periventricular

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Encephalomalacia; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

This was a preliminary study to evaluate the mechanisms by which spinal stimulation and mobility may impact muscle coordination, spasticity, and strength. The study population was limited in number and range of impairments and future trials will be required to evaluate the generalizability of results.

Results Point of Contact

• Title: Katherine Steele
• Organization: University of Washington

kmsteele@uw.edu

206-685-2390

Study Officials

• Katherine Steele, PHD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Mechanical Engineering

Model Details: Randomized order of visits with individual and combined effects of mobility devices and spinal stimulation.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 29, 2022
• Study Start: August 4, 2022
• Primary Completion: May 13, 2023
• Study Completion: May 13, 2023
• Last Updated: September 18, 2026
• Results First Posted: September 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)