51 Participants Needed

Electrical Stimulation for Cerebral Palsy

(CP Trial)

AB
Overseen ByAhad Behboodi, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should be seizure-free or have well-controlled seizures, which might imply that continuing seizure medication is allowed.

Is neuromuscular electrical stimulation (NMES) safe for use in humans?

NMES has been used for many years in conditions like cerebral palsy and stroke, with studies showing it can improve muscle function and mobility. While there is limited information on major adverse events, patient tolerability and precise timing of stimulation are important considerations for safety.12345

How does the treatment NMES differ from other treatments for cerebral palsy?

NMES (Neuromuscular Electrical Stimulation) is unique because it uses electrical impulses to stimulate muscles, potentially improving muscle strength, reducing spasticity (muscle stiffness), and enhancing motor skills in children with cerebral palsy. Unlike traditional physical therapy, NMES can be precisely timed to assist with specific movements, such as walking, and may offer benefits when used alongside other therapies.23467

What data supports the effectiveness of the treatment NMES for cerebral palsy?

Research shows that neuromuscular electrical stimulation (NMES) can help improve movement and walking ability in children with cerebral palsy. Studies found that children using NMES showed better motor function and increased muscle efficiency, suggesting it can be a useful addition to physical therapy.23689

Who Is on the Research Team?

AB

Ahad Behboodi, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for children with cerebral palsy who can walk on a treadmill. Specific eligibility criteria are not provided, but typically participants must be in stable health and able to comply with study requirements.

Inclusion Criteria

I do not have conditions like severe scoliosis or hip problems.
I can travel to the University of Nebraska at Omaha twice.
My seizures are well-controlled or I don't have seizures.
See 8 more

Exclusion Criteria

I have been diagnosed with athetoid or ataxic cerebral palsy.
My main scoliosis curve is over 49 degrees.
I have severe joint movement limitations or muscle tightness.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo two assessment sessions with NMES applied to leg muscles while walking on a treadmill

3 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NMES
Trial Overview The trial is testing neuromuscular electrical stimulation (NMES) applied to leg muscles while walking on a treadmill. It aims to find the best NMES settings that improve walking ability in children with cerebral palsy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cerebral Palsy GroupExperimental Treatment1 Intervention
The Cerebral Palsy Group (CP), intervention group, will receive a low power electrical stimulation, Neuromuscular Electrical Stimulation (NMES), on different combination of their lower limb muscles while walking on the treadmill.
Group II: Healthy Adults GroupActive Control1 Intervention
The Healthy Adults Group (HA) will receive a similar low power electrical stimulation, Neuromuscular Electrical Stimulation (NMES), as that received by the Cerebral Palsy Group. However, they will will only receive NMES in specific muscle groups and the only variable across conditions will be the power of stimulation.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Citations

Clinical use of neuromuscular electrical stimulation for children with cerebral palsy, Part 1: Lower extremity. [2019]
The effects of a neuromuscular electrical stimulation home program on impairments and functional skills of a child with spastic diplegic cerebral palsy: a case report. [2006]
Wide-pulse-high-frequency neuromuscular electrical stimulation in cerebral palsy. [2017]
Neuromuscular electrical stimulation versus volitional isometric strength training in children with spastic diplegic cerebral palsy: a preliminary study. [2018]
Neuromuscular electrical stimulation to improve gross motor function in children with cerebral palsy: a meta-analysis. [2019]
A Scoping Review of Neuromuscular Electrical Stimulation to Improve Gait in Cerebral Palsy: The Arc of Progress and Future Strategies. [2020]
Toward a hybrid exoskeleton for crouch gait in children with cerebral palsy: neuromuscular electrical stimulation for improved knee extension. [2020]
Non-Invasive Brain Stimulation in Children With Unilateral Cerebral Palsy: A Protocol and Risk Mitigation Guide. [2020]
Clinical use of neuromuscular electrical stimulation for children with cerebral palsy, Part 2: Upper extremity. [2019]
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