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

NCT06811545 | Not Yet Recruiting FDA Device

• 2 other identifiers: 0406-24-FBP20GM109090
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Healthy Adults; Cerebral Palsy Children

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (enrollment) and the end of assessment at 3 weeks

Study Arms (2)

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.

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.

Device: Neuromuscular Electrical Stimulation (NMES)

Interventions

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.

Cerebral Palsy Group; Healthy Adults Group

Eligibility Criteria

• Age: 7 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Nebraska at Omaha, Biomechanics Research Building

Omaha, Nebraska, 68182, United States

Location

Study Officials

• Ahad Behboodi, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahad Behboodi, PhD

CONTACT

402-554-7525; abehboodi@unomaha.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)