Spinal Stimulation and Mobility Devices

NCT05520359 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00014877
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric; Mobility Aids; Assistive Technology; Spinal Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Modified Ashworth Scale

  Physical exam conducted at the beginning and end of each experimental session.

• Plantarflexor Muscle Strength

  Physical exam conducted at the beginning and end of experimental session.

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 during session.

Also known as: Biomotum SPARK, Trexo, Portable Mobility Aid for Children (PUMA, ENLITEN)

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

RECRUITING

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

Study Officials

• Katherine Steele, PHD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Steele, PHD

CONTACT

206-685-2390; kmsteele@uw.edu

Katie Landwehr, MS

CONTACT

937-231-1205; klandweh@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• 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 (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)