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

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy Children; Healthy Adults

• Registration Number: NCT06811545
• Lead Sponsor: University of Nebraska

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.

Detailed Description

Children with cerebral palsy (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 neuromuscular electrical stimulation (NMES) on their lower limb muscles, using surface electrodes, while gait dynamics are assessed. The 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 study aims to investigate the optimal level of intensity. Investigators intend to quantify neuroprosthetic, i.e., immediate effects during NMES assistance on gait kinematics.

Up to 36 children between the ages of 7 to 18 who are diagnosed with spastic diplegic cerebral palsy and GMFCS level 1 - 3 will be recruited for this study. The study consists of two assessment sessions. During all sessions, the participants will walk on a treadmill with and without NMES assistance at self selected walking speed. The assessment sessions consist of multiple NMES conditions. Each condition lasts about 1 minute and will be repeated 3 times, with 30 seconds rest between trials for each condition and 5 minutes between each condition. The total walking time will not exceed 30 minutes. Each visit will last about 3 hours. The assessment sessions will begin with a no-stimulation condition and follow with multiple NMES conditions consisting of NMES assistance to various lower limb muscle combinations.

With the aim of developing our NMES system and improving result feasibility, we will recruit up to 15 healthy adults aged between 20 and 40 before involving CP subjects. They will undergo a similar procedure as the CP group with a maximum of 2 sessions. However, unlike the CP group, they will not be exposed to multiple NMES conditions. Instead, they will receive NMES only on a specific muscle combination. The only difference across the conditions will be the intensity of the stimulation: participants will experience either no stimulation, sensory-level stimulation, or motor threshold (MT) stimulation.

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Status Verified: 2025-06
• Study Start: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Primary Completion: 2029-06
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Gait Variable Index (GDI)	Baseline (enrollment) and the end of assessment at 3 weeks	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.

Trial Locations

Locations (1)

University of Nebraska at Omaha, Biomechanics Research Building; 🇺🇸 Omaha, Nebraska, United States