Cerebral Palsy ChildrenCPNCT06811545
Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children With Cerebral Palsy
A study testing Neuromuscular Electrical Stimulation (NMES) in people with Cerebral Palsy Children and Healthy Adults, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy Children, Healthy Adults
- What is being tested?
- Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 exercise tolerance (Asthma Control Test screen)
- History of cardiac disease (American Heart Association, AH,) screen)
- Excessive LE joint pain during walking
- Severely limited range of joint motion/ irreversible muscle contractures, i.e.> 10° knee flexion, >15° hip flexion contractures, or >5° plantarflexion contractures
- LE surgery or significant injury within 1 yr.
- Healthy adults (control) group:
- Adults with any chronic illnesses or medical conditions that could impact their health.
- Adults with significant behavioral or emotional issues that could indicate developmental disorders or psychological conditions.
- Adults with diagnosed developmental disorders (e.g., autism, ADHD, learning disabilities)
- Adults with surgery on their lower limb within the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska at Omaha, Biomechanics Research Building
Omaha, Nebraska, 68182
Ahad Behboodi, PhD, 402-554-7525, abehboodi@unomaha.edu
About this study
Official title: Exploring the Effects of Multi-Joint Neuromuscular Electrical Stimulation on Training Gait of Children With Cerebral Palsy
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.
Read the detailed description
Children with cerebral palsy (CP) can have trouble with daily tasks such as walking. This raises their risk of disability as they age into their teens. Current treatments are not very effective. In this study, children with CP will walk on a treadmill while receiving neuromuscular electrical stimulation (NMES) on their lower limb muscles, using surface electrodes, while their gait dynamics are assessed, using Inertial Measurement Unit (IMU) sensors. Our proposed study aims to gather preliminary evidence to support the potential efficacy of NMES assistance to muscles across all lower limb joints during walking, i.e., multi-joint NMES assistance. Additionally, we aim to investigate the optimal level of intensity. We intend to quantify neuroprosthetic, i.e., immediate effects during NMES assistance on gait kinematics. 40 children between the ages of 7 to 18 who are diagnosed with spastic diplegic cerebral palsy and GMFCS level I-III, and 25 healthy adults will be recruited for this study. The study consists of one pilot session and two assessment sessions. During the pilot session, participants will walk on the treadmill at their self-selected speed while two IMU sensors measure their shank velocity and acceleration. No stimulation will be applied to the subjects during the pilot session, as we aim to only validate and improve the software that triggers the stimulation during the gait, i.e., our gait phase detection system. During assessment sessions, subjects will walk on a treadmill with and without NMES assistance at their self-selected walking speed. The assessment sessions consist of multiple NMES conditions. Each condition lasts about 1 minute and will be repeated 3 times, with 30 seconds rest between trials for each condition and 5 minutes between each condition. The total walking time will not exceed 30 minutes. Each visit will last about 3 hours. The first session will also include a consent process, which will add an extra 30 minutes. The assessment sessions will begin with a no-stimulation condition and will be followed by multiple NMES conditions consisting of NMES assistance to various lower limb muscle combinations.
- Conditions
- Cerebral Palsy Children, Healthy Adults
- Being tested
- Neuromuscular Electrical Stimulation (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation (NMES)Device
Children with CP can have trouble with daily tasks such as walking. This raises their risk of disability as they age into their teens. Current treatments are not very effective. In this study, children with CP will walk on a treadmill while receiving NMES on their lower limb muscles, using surface electrodes, while their gait dynamics are assessed. Our proposed study aims to gather preliminary evidence to support the potential efficacy of NMES assistance to muscles across all lower limb joints during walking, i.e., multi-joint NMES assistance. Additionally, the investigators aim to investigate the optimal level of intensity.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy Group | Experimental | 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. Receives: Device: Neuromuscular Electrical Stimulation (NMES) |
| Healthy Adults Group | Active comparator | 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. Receives: Device: Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Variable Index (GDI)
Gait Variable Index (GDI) is an index of gait pathology based on 15 different kinematic measures (bilaterally) or nine unilaterally. The GDI score ranges from 0 to 100 where 100 represents atypically developing's (TD) normal GDI score.
Measured: Baseline (enrollment) and the end of assessment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start15 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Ahad Behboodi, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811545
- Sponsor's protocol ID
- 0406-24-FB
- Other IDs
- P20GM109090
- Acronym
- CP
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No