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

Launched by UNIVERSITY OF NEBRASKA · Jan 31, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether gentle electrical stimulation can help children with cerebral palsy (CP) walk better. The technique used is called neuromuscular electrical stimulation (NMES), which sends small electrical pulses to the muscles in the legs to help them move more easily. Children participating in the study will walk on a treadmill while receiving this stimulation, and researchers will test different settings to see which one works best for improving walking ability.

To be eligible for this trial, children need to be between 7 and 18 years old and have a diagnosis of spastic diplegic CP, which affects their ability to walk. They should be able to walk with or without assistance and have certain physical abilities, like enough range of motion in their ankles. Participants need to be able to communicate any discomfort and should not have certain other medical conditions that could interfere with the study. This is a great opportunity for children who meet the criteria to potentially improve their walking skills while contributing to important research.

Gender

ALL

Eligibility criteria

• • \*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.