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NCT06811545

Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children With Cerebral Palsy

Sponsor: University of Nebraska

View on ClinicalTrials.gov

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.

Official title: Exploring the Effects of Multi-Joint Neuromuscular Electrical Stimulation on Training Gait of Children With Cerebral Palsy

Key Details

Gender

All

Age Range

7 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2029-07

Last Updated

2026-03-24

Healthy Volunteers

Yes

Conditions

Cerebral Palsy Children Healthy Adults

Interventions

DEVICE

Neuromuscular Electrical Stimulation (NMES)

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.

\*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 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.

Locations (1)

University of Nebraska at Omaha, Biomechanics Research Building

Omaha, Nebraska, United States