Pediatric Neural Sleeve Validation
Key facts
- Who runs it
- University of California, Los Angeles
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- Jan 2024
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cionic Neural Sleeve NS-100
- Record updated
- 25 July 2024
- Why it stopped
- unable to obtain neural sleeve through partner company
Who can take part
- Age
- 8 years to 14 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Age 8-14 years
- Diagnosis of spastic cerebral palsy affecting one or both legs
- Able to independently sit, stand and walk with or without assistive device or bracing
- Able to walk at least 50 feet with or without assistive device or bracing
- Able to understand and follow basic instructions in English
- A Parent/Guardian must accompany and be present with the child participant
Who cannot take part
- Cognitive impairment that would preclude participation
- Lower motor neuron disease or injury that may impair response to stimulation
- Diagnosis of any neurologic disease aside from spastic cerebral palsy
- Dyskinetic movement disorder
- Have skin conditions of the affected lower limb, including cuts, burns or lesions that would preclude placement of electrodes
- Have a latex allergy
Where in United States
- University of California, Los AngelesLos Angeles, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Patient with Cerebral Palsy, no interventionNo study treatment, for comparison
Gait analysis of cerebral palsy patients without any intervention.
- Patient with Cerebral Palsy, with sleeveExisting treatment, for comparison
Gait analysis of cerebral palsy patients while wearing neural sleeve.
Treatment: Cionic Neural Sleeve NS-100
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Validation of Cionic Neural Sleeve for Use in Pediatric Patients With Cerebral Palsy
- Record updated
- 25 July 2024