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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06811545
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy Children
  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
7 Years - 40 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Sep 2025
Primary completion
Jun 30, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska at Omaha, Biomechanics Research BuildingOmahaNebraska68182
Ahad Behboodi, PhD
402-554-7525

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