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

ConditionsCerebral Palsy Children Healthy Adults

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-40

SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

65 Participants

are divided into 2 treatment groups

Group A: Cerebral Palsy GroupExperimental treatment 1 intervention

Group B: Healthy Adults GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: