Electrical stimulation to help kids with cerebral palsy walk better

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will apply surface neuromuscular electrical stimulation (NMES) to leg muscles while children with spastic diplegic CP walk on a treadmill to see if different stimulation settings improve gait. The study uses IMU sensors to measure gait dynamics and aims to identify the most effective stimulation level for multi-joint assistance across the lower limbs. A pilot session will validate the stimulation-triggering software, followed by two assessment sessions to compare NMES-enabled walking to baseline. The trial also includes healthy adults to provide comparative data. The goal is to generate preliminary evidence on NMES-based gait assistance and establish optimal parameters for future work.

Why it matters

Who can join: the full rules

\*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.

Where it's running

• University of Nebraska at Omaha, Biomechanics Research Building
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: Ahad Behboodi, PhD — University of Nebraska
• Study coordinator: Ahad Behboodi, PhD
• Email: abehboodi@unomaha.edu
• Phone: 402-554-7525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.