Recruiting

NMES

Sponsor:

University of Nebraska

Code:

NCT06811545

Conditions

Cerebral Palsy Children

Healthy Adults

Eligibility Criteria

Sex: All

Age: 7 - 40

Healthy Volunteers: Accepted

Interventions

Neuromuscular Electrical Stimulation (NMES)

Study Details

Brief 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.

Conditions

Cerebral Palsy Children

Healthy Adults

Study ID

NCT06811545

Start date

Jun 15, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 40

Healthy Volunteers: Accepted

\*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.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cerebral Palsy Group

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.

active comparator: Healthy Adults Group

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.

Interventions

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.

Primary outcome measure

  • Gait Variable Index (GDI) [ Time Frame: Baseline (enrollment) and the end of assessment at 3 weeks ]

Central Contacts and Locations

Central contacts

Ahad Behboodi, PhD

402-554-7525abehboodi@unomaha.edu

Locations

University of Nebraska at Omaha, Biomechanics Research Building

Recruiting

Omaha, Nebraska, United States, 68182

Contacts

Ahad Behboodi, PhD

402-554-7525abehboodi@unomaha.edu

More Information

Sponsor

University of Nebraska

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.