Pediatric Neural Sleeve Validation

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Dec 13, 2022

Keywords

ClinConnect Summary

This is a comparative cohort study testing the accuracy of a wearable Neural Sleeve in collecting kinematic data in children (age 8-14 years) with CP and healthy control subjects as well as the Sleeve's ability to normalize gait patterns in patients with CP. The Cionic Neural Sleeve measures information on how people move. The system consists of 4 leg straps, 2 foot sensors, and 2 foot insoles (or pressure sensors), connected by insulated wires to a battery-powered control box worn on the thigh. The Cionic sensing devices are made up of sensors that are either part of wearable garments held...

Gender

ALL

Eligibility criteria

• 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

Trial Officials