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Search / Trial NCT05660096

Pediatric Neural Sleeve Validation

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

Trial Information

Current as of January 22, 2025

Withdrawn

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

Rachel Thompson

Principal Investigator

University of California, Los Angeles

About University Of California, Los Angeles

The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.

Locations

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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