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Spinal Stimulation + Mobility Devices for Cerebral Palsy
N/A
Recruiting
Led By Katherine Steele, PHD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are 4-70 years of age
Have a neurologic condition
Must not have
Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
Have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparing first and last minute of walking on treadmill at each experimental session.
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of a new combination therapy for children with cerebral palsy- spinal stimulation and mobility devices.
Who is the study for?
This trial is for children and adults aged 4-70 with cerebral palsy or other brain-related conditions who can follow simple instructions and are medically stable. It's not for those with rheumatic diseases, active cancer, implanted stimulators or drug delivery devices, recent orthopedic surgery in the legs, uncontrolled seizures, severe osteoporosis on treatment, or significant cardiovascular issues.
What is being tested?
The study tests how non-invasive spinal stimulation combined with mobility devices affects movement in people with cerebral palsy. Participants will use these techniques during lab visits to see if there's an immediate improvement in their ability to move.
What are the potential side effects?
Potential side effects may include discomfort from the spinal stimulation or using the mobility device. There might also be fatigue due to physical activity involved in the testing process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 70 years old.
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I have a condition affecting my nervous system.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a rheumatic disease like rheumatoid arthritis or lupus.
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I have a bone injury or condition that could affect my ability to participate in physical rehab or tests.
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I have seizures that are not controlled by medication.
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I am being treated for osteoporosis.
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I have a serious health condition like high blood pressure over 170/100, heart or lung disease, blood clotting issues, or need blood thinners.
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I do not have heart or muscle conditions that stop me from doing physical therapy.
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My cancer is currently active.
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I haven't had leg or brain surgery in the past year that could affect study results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ physical exam conducted at the beginning and end of experimental session.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~physical exam conducted at the beginning and end of experimental session.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Muscle Coordination
Secondary study objectives
Modified Ashworth Scale
Plantarflexor Muscle Strength
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neurologic DisordersExperimental Treatment2 Interventions
Evaluation of individual and combined effects of mobility devices and spinal stimulation for individuals with neurologic disorders.
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,914,363 Total Patients Enrolled
Seattle Children's HospitalOTHER
310 Previous Clinical Trials
5,231,210 Total Patients Enrolled
Katherine Steele, PHDPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a rheumatic disease like rheumatoid arthritis or lupus.I can share my experience and comfort level during lab visits.You need help breathing from a machine.I can follow simple instructions and do tasks when guided.I have seizures that are not controlled by medication.I am between 4 and 70 years old.My health condition is stable.My cancer is currently active.I have a bone injury or condition that could affect my ability to participate in physical rehab or tests.I am being treated for osteoporosis.I have a serious health condition like high blood pressure over 170/100, heart or lung disease, blood clotting issues, or need blood thinners.I do not have heart or muscle conditions that stop me from doing physical therapy.I have a condition affecting my nervous system.You have a medical device implanted in your body that stimulates nerves or delivers medication.I haven't had leg or brain surgery in the past year that could affect study results.
Research Study Groups:
This trial has the following groups:- Group 1: Neurologic Disorders
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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