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Gait Metric Validation of the Cionic Neural Sleeve

NCT06503354 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2025-12-18

No results posted yet for this study

Summary

The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway. The spatiotemporal gait parameters obtained from the Zeno walkway have been rigorously validated and will represent the "gold standard" ground truth measurements in the proposed protocol. Confirming the validity of the Neural Sleeve metrics offers benefit to individuals who utilize the device by providing confidence that calculated gait reports are accurate and can be used to inform usage of the device and associated gait changes over time. Findings of inaccuracy would still offer benefit in the form of knowing that the Neural Sleeve metrics need to be used with caution and/or updated to provide correct outcomes to users.

Conditions

  • Validation Study

Interventions

DEVICE

Neural Sleeve and Zeno walkway

A standard manual stopwatch will be used to record time. The Zeno pressure gait mat will be laid flat on the ground and used for all walking conditions/speed. Participants will perform two 5-minute walking bouts for each of the four walking conditions while wearing the Neural Sleeve without electrical stimulation. For normal walking speed, participants walked at their normal, comfortable pace for 5 minutes. For fast walking speed, participants walked to cover as much distance as possible for 5 minutes. For intermittent-slow speed, participants were instructed to walk as if browsing in a museum. For slow speed, participants walked at a slow, steady pace. The order of conditions was randomized. They will walk back and forth along a 12-meter course with the gait mat in the center of the course. Participants will not receive any intervention or treatment. Simultaneously, the Zeno walkway will be operated according to manufacturer's instructions.

Sponsors & Collaborators

  • Cionic, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-08
Primary Completion
2025-12-01
Completion
2025-12-11
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06503354 on ClinicalTrials.gov