Recruiting

Spinal Stimulation & Mobility Devices

Sponsor:

University of Washington

Code:

NCT05520359

Conditions

Cerebral Palsy

Stroke

Premature Birth

Hypoxic-Ischemic Encephalopathy

Periventricular Leukomalacia

Eligibility Criteria

Sex: All

Age: 4 - 70

Healthy Volunteers: Not accepted

Interventions

Mobility Device

Spinal Stimulation

Study Details

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

Study ID

NCT05520359

Start date

Aug 4, 2022

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Neurologic Disorders

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

Interventions

Mobility Device

Use of mobility device during session.

Spinal Stimulation

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

Primary outcome measure

  • Muscle Coordination [ Time Frame: Comparing first and last minute of walking on treadmill at each experimental session. ]

Central Contacts and Locations

Central contacts

Katherine Steele, PHD

206-685-2390kmsteele@uw.edu

Katie Landwehr, MS

937-231-1205klandweh@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Katie Landwehr, MS

937-231-1205klandweh@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Aug 13, 2025

Last verified

Aug, 2025

Keywords

  • Pediatric
  • Mobility Aids
  • Assistive Technology
  • Spinal Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-08-13.