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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM109090 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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 their gait dynamics are assessed, using Inertial Measurement Unit (IMU) sensors. 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, we aim to investigate the optimal level of intensity. We intend to quantify neuroprosthetic, i.e., immediate effects during NMES assistance on gait kinematics. 40 children between the ages of 7 to 18 who are diagnosed with spastic diplegic cerebral palsy and GMFCS level I-III, and 25 healthy adults will be recruited for this study. The study consists of one pilot session and two assessment sessions. During the pilot session, participants will walk on the treadmill at their self-selected speed while two IMU sensors measure their shank velocity and acceleration. No stimulation will be applied to the subjects during the pilot session, as we aim to only validate and improve the software that triggers the stimulation during the gait, i.e., our gait phase detection system. During assessment sessions, subjects will walk on a treadmill with and without NMES assistance at their 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 first session will also include a consent process, which will add an extra 30 minutes. The assessment sessions will begin with a no-stimulation condition and will be followed by multiple NMES conditions consisting of NMES assistance to various lower limb muscle combinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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*Inclusion Criteria*
CP Group:
Healthy adults (control) group:
*Exclusion Criteria*
CP Group:
Healthy adults (control) group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahad Behboodi, PhD | Contact | 402-554-7525 | abehboodi@unomaha.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ahad Behboodi, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska at Omaha, Biomechanics Research Building | Omaha | Nebraska | 68182 | United States |
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