Stroke Clinical Trial
Official title:
Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Seattle Children's Hospital |
United States,
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. |
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