Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children W… (NCT06811545) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children With Cerebral Palsy
United States65 participantsStarted 2026-05
Plain-language summary
The goal of this study is to see if gentle electrical stimulation can help children with cerebral palsy (CP) walk more easily. This stimulation, called neuromuscular electrical stimulation (NMES), sends small pulses to muscles to help them activate. Researchers will test different ways of using NMES to find out which method works best.
Participants will walk on a treadmill at a comfortable speed while NMES is applied to leg muscles. The study will compare different stimulation settings to see which one helps the most.
Who can participate
Age range
7 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\*Inclusion Criteria\*
CP Group:
* Age 7-18
* Diagnosis of spastic diplegic cerebral palsy (CP)
* GMFCS level I-III (be able to walk with or without assistive devices)
* MIGR \< 40% femoral head covering in acetabulum
* Crouch, equinus, or jump gait
* At least 0° passive dorsiflexion range of motion (ROM)
* Sufficient visuoperceptual, cognitive, and communication skills
* Seizure-free or well-controlled seizures
* No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability
* Ability to travel to the University of Nebraska at Omaha two times
* Ability to communicate pain or discomfort
* Ability to obtain child assent and obtain parent/guardian consent
Healthy adults (control) group:
* Adults aged 20 to 40
* Adults with good physical health
* Adults with the ability to follow verbal instructions
* Adults with the ability to walk on a treadmill for 15 minutes
* No orthopedic surgery on the lower limb within the past 3 months
\*Exclusion Criteria\*
CP Group:
* Diagnosis of athetoid or ataxic cerebral palsy (CP)
* Scoliosis with primary curve \> 49%
* Spinal fusions extending into the pelvis
* Lower Extremity (LE) joint instability or dislocation
* Severe tactile hypersensitivity
* LE botulinum injections in the past 6 mo
* Implanted medical device contraindicative of functional electrical stimulation (FES)
* Pregnancy
* Severe LE spasticity (Modified Ashworth Scale score of 4 or greater)
* History of pulmonary disease limiting exerc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gait Variable Index (GDI)
Timeframe: Baseline (enrollment) and the end of assessment at 3 weeks