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) — DEVICEChildren 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 GroupThe 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 GroupThe 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
- Ahad Behboodi, PhD402-554-7525
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Nebraska at Omaha, Biomechanics Research Building | Omaha | Nebraska | 68182 |
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