Spinal Stimulation and Mobility Devices

Stroke Clinical Trial

Official title:

Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520359
• Other study ID #: STUDY00014877
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Washington
• Contact: Katherine Steele, PHD
• Phone: 206-685-2390
• Email: kmsteele[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 mobility device use and electrical spinal stimulation, impact movement mechanics in people with neurological conditions to inform long-term studies and eventual implementation into clinical practice. Mobility devices 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 these approaches for individuals with neurologic disorders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cerebral Palsy
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Leukomalacia, Periventricular
• Periventricular Leukomalacia
• Premature Birth
• Stroke

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modified Ashworth Scale	Change in summed score of spasticity from lower-extremity muscles. Lower values indicate less spasticity.	Physical exam conducted at the beginning and end of each experimental session.
Secondary	Plantarflexor Muscle Strength	Change in maximum voluntary contraction level of the plantarflexor muscles taken as the average of three trials where the participant exerts the maximum amount of force measured from a handheld dynamometer with verbal encouragement.	Physical exam conducted at the beginning and end of experimental session.