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Wearable Leg Sleeve for Cerebral Palsy

N/A

Waitlist Available

Led By Rachel Thompson

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 2 hours for follow-up clinical visit

Awards & highlights

Study Summary

This trial tests if a wearable leg sleeve can measure and improve walking in people with cerebral palsy. Participants will have physical exams and be fit with a device that sends signals to the muscles to help make walking easier and smoother. Gait analysis will be used to compare the data from the device.

Who is the study for?

This trial is for children aged 8-14 with spastic cerebral palsy affecting their legs, who can sit, stand, and walk at least 50 feet independently or with help. They must understand English and be accompanied by a parent/guardian. It's not for those with other neurological diseases, lower limb skin conditions, latex allergies, cognitive impairments that prevent following instructions, or certain movement disorders.Check my eligibility

What is being tested?

The study tests the Cionic Neural Sleeve NS-100 on kids with CP to see if it helps them walk better. Participants will wear the sleeve during a visit to Kameron Gait and Motion Analysis Center where their walking patterns are analyzed before and after using the device in 'corrective mode' which stimulates muscles to improve gait.See study design

What are the potential side effects?

While specific side effects aren't detailed here as it's a non-drug device being tested; potential risks may include discomfort from wearing the sleeve or skin irritation from electrode placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 2 hours for follow-up clinical visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to 2 hours for follow-up clinical visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 2 hours for follow-up clinical visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neuromodulation activity (motor unit potential)

Range of motion (degrees) in lower extremities

Secondary outcome measures

Patient-reported physical function (PROMIS score)

Trial Design

2Treatment groups

Active Control

Group I: Patient with Cerebral Palsy, no interventionActive Control1 Intervention

Gait analysis of cerebral palsy patients without any intervention.

Group II: Patient with Cerebral Palsy, with sleeveActive Control1 Intervention

Gait analysis of cerebral palsy patients while wearing neural sleeve.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cionic, Inc.Industry Sponsor

3 Previous Clinical Trials

72 Total Patients Enrolled

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,238 Total Patients Enrolled

2 Trials studying Cerebral Palsy

124 Patients Enrolled for Cerebral Palsy

Rachel ThompsonPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Patient with Cerebral Palsy, with sleeve Clinical Trial Eligibility Overview. Trial Name: NCT05660096 — N/A

Cerebral Palsy Research Study Groups: Patient with Cerebral Palsy, no intervention, Patient with Cerebral Palsy, with sleeve

Cerebral Palsy Clinical Trial 2023: Patient with Cerebral Palsy, with sleeve Highlights & Side Effects. Trial Name: NCT05660096 — N/A

Patient with Cerebral Palsy, with sleeve 2023 Treatment Timeline for Medical Study. Trial Name: NCT05660096 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient base of this research restricted to those under 40?

"According to the particular criteria listed for this trial, suitable applicants must be between 8 and 14 years old. There are 146 other clinical trials that cater to minors while 26 offer services to individuals over 65."

Answered by AI

Is enrolment for this scientific experiment still being accepted?

"As per information available on clinicaltrials.gov, this research is not presently open for recruitment. Initially posted January 1st 2023 and last updated December 13th 2022, the trial has since ceased to accept participants; however there are 160 other trials actively seeking volunteers at present."

Answered by AI

What criteria must a person meet to take part in this research endeavor?

"This clinical investigation is seeking 30 minors, between 8 and 14 years old with cerebral palsy diagnoses. Additionally, the candidates must be able to autonomously sit, stand or walk aided/unaided; understand verbal commands in English; travel at least 50 feet unassistedly; and have a parent/guardian present during the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pediatric Neural Sleeve Validation

Rachel Thompson, MD 2024. "Pediatric Neural Sleeve Validation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05660096.

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