Clinical trial NCT06811545: Evaluating the Effects of an Electrical Stimulator on Improving the Walking Ability of Children With Cerebral Palsy
Official title: Exploring the Effects of Multi-Joint Neuromuscular Electrical Stimulation on Training Gait of Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy Children
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2025-02-06
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 the 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.

Eligibility criteria: Inclusion Criteria:

* Age 7-18
* Diagnosis of spastic diplegic CP
* GMFCS level I-III (be able to walk with or without assistive devices)
* MIGR \< 40% femoral head covering in acetabulum
* Crouch, equinus, or jump gait
* At least 0° passive dorsiflexion range of motion (ROM)
* Sufficient visuoperceptual, cognitive, and communication skills
* Seizure-free or well-controlled seizures
* No other neurological or musculoskeletal disorders (e.g. dystonia, severe scoliosis, hip instability
* Ability to travel to the University of Nebraska at Omaha two times
* Ability to communicate pain or discomfort
* Ability to obtain child assent and obtain parent/guardian consent

Exclusion Criteria:

* Diagnosis of athetoid or ataxic CP
* Scoliosis with primary curve \> 49%
* Spinal fusions extending into the pelvis
* Lower Extremity (LE) joint instability or dislocation
* Severe tactile hypersensitivity
* LE botulinum injections in the past 6 mo
* Implanted medical device contraindicative of functional electrical stimulation (FES)
* Pregnancy
* Severe LE spasticity (Modified Ashworth Scale score of 4 or greater)
* History of pulmonary disease limiting exercise tolerance (Asthma Control Test screen)
* History of cardiac disease (AHA screen)
* Excessive LE joint pain during walking
* Severely limited range of joint motion/ irreversible muscle contractures, i.e.\> 10° knee flexion, \>15° hip flexion contractures, or \>5° plantarflexion contractures
* LE surgery or significant injury within 1 yr.

Primary outcomes:
measure: Gait Variable Index (GDI)
timeFrame: From enrollment to the end of assessment at 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska at Omaha, Biomechanics Research Building
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Ahad Behboodi, PhD
role: PRINCIPAL_INVESTIGATOR
References: