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Pediatric Neural Sleeve Validation

NCT05660096 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-07-25

No results posted yet for this study

Summary

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.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

Cionic Neural Sleeve NS-100

Sleeve applies neuromuscular stimulation as patients walk to help contract appropriate muscles at appropriate times.

Sponsors & Collaborators

Principal Investigators

  • Rachel Thompson · University of California, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660096 on ClinicalTrials.gov