Status:
RECRUITING
Transcutaneous Stimulation for Neurological Populations
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Seattle Children's Hospital
Conditions:
Neurological Disorder
Cerebral Palsy
Eligibility:
All Genders
4-70 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal s...
Eligibility Criteria
Inclusion
- have a neurologic condition
- can walk 20 yards, with or without an assistive device
- have stable medical condition
- are capable of performing simple cued motor tasks and who can follow 2-3 step commands
- have ability to attend up to 5 sessions per week physical therapy sessions and testing activities
- have adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period.
- who are volunteering to be involved in this study
- can read and speak English
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04467437
Start Date
January 1 2021
End Date
December 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98115