Cerebral Palsy Clinical Trial
Official title:
Validation of Cionic Neural Sleeve for Use in Pediatric Patients With Cerebral Palsy
In individuals with cerebral palsy (CP), signals from the brain to the muscles that are required for coordinated walking are either poorly controlled or absent. This results in abnormal walking (or gait) patterns and difficulty with independent movement. The purposes of this study is to test a device - a wearable leg sleeve - that can measure the abnormal signals sent from the brain to the muscles and the resulting movements and then send signals to the muscles to help make walking easier and smoother. 20 participants with, and 10 participants without, CP are being asked to come to test the device at the Kameron Gait and Motion Analysis Center. This requires one visit, which will last approximately 2-4 hours. During this visit, participants will undergo a physical exam and will be fit for the device on their leg. The participant will be asked to move their legs while the device is on to calibrate the device, and then the participants will walk while the device is interpreting their movement patterns. Participants with cerebral palsy will additionally walk with the device on their leg in a "corrective mode," where the device will provide stimulation to certain muscles in their leg in order to improve the patient's walking pattern. Last, participants will complete an instrumented gait analysis. Gait analysis involves recording movement patterns during walking using small reflective markers and sensor taped to the participant's legs and trunk. A series of cameras and computers are used to record the leg position and the walking speed. This data will be compared to the data provided from the device.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 14 Years |
Eligibility | Inclusion Criteria: 1. Age 8-14 years 2. Diagnosis of spastic cerebral palsy affecting one or both legs 3. Able to independently sit, stand and walk with or without assistive device or bracing 4. Able to walk at least 50 feet with or without assistive device or bracing 5. Able to understand and follow basic instructions in English 6. A Parent/Guardian must accompany and be present with the child participant Exclusion Criteria: 1. Cognitive impairment that would preclude participation 2. Lower motor neuron disease or injury that may impair response to stimulation 3. Diagnosis of any neurologic disease aside from spastic cerebral palsy 4. Dyskinetic movement disorder 5. Have skin conditions of the affected lower limb, including cuts, burns or lesions that would preclude placement of electrodes 6. Have a latex allergy |
Country | Name | City | State |
---|---|---|---|
United States | University of California - Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Cionic, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion (degrees) in lower extremities | Participants will be evaluated on range of motion in degrees by performing dorsiflexion, plantarflexion, knee extension, and knee flexion exercises. The physical orientation of both legs and feet, selective motor control, and lower extremity strength will also be evaluated while participants walk for up to two minutes. Specific measures include ambulation speed (km per hour), walking cadence (steps per minute), stride width (inches), and stride length (inches). Baseline measures will be obtained in a standard neuromuscular physical exam performed by a licensed physician or physical therapist. During the intervention phase of the study, these measures will be obtained in a formal limited instrument gait analysis while wearing a neural sleeve. Movement patterns will be captured using small reflective markers and sensors to record kinematic output. |
2 to 4 hours for formal gait analysis visit | |
Primary | Neuromodulation activity (motor unit potential) | Kinematic data from the instrumented gait analysis will be compared to kinematic data collected from the Cionic Neural Sleeve. Specifically, electrical activity, measured by motor unit potential (E-MUP) waveforms and their magnitudes, obtained via electromyography during the gait analysis will be compared to the electrical activity obtained from neuromodulation via the neural sleeve. Neuromodulation will be assessed on the four main muscle groups: quadriceps, hamstrings, calf, and tibialis anterior. | 2 to 4 hours for formal gait analysis visit, data collection continuously for 12 weeks after study visit | |
Secondary | Patient-reported physical function (PROMIS score) | Patient-Reported Outcomes Measurement Information System (PROMIS) scores will be collected from cerebral palsy patients at the conclusion of the 12-week neural sleeve data collection period. The PROMIS questionnaire will generate patient-reported scores to measure physical function. | 1 to 2 hours for follow-up clinical visit |
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