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Completed

NCT Number: NCT06503354

Gait Metric Validation of the Cionic Neural Sleeve

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.

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Key information

Conditions

Validation Study

Age range

22 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland State University, Department of Health Sciences and Human Performance

Cleveland, Ohio, 44115-2214, United States

About this study

The study aims to validate the gait metrics of the Neural Sleeve in healthy adult volunteers. All participants will wear a Neural Sleeve on their dominant leg. The Zeno pressure gait mat will be laid flat on the ground and used for all four walking conditions. Participants will perform two 5-minute walking bouts at each of the four speed conditions while wearing the Cionic Neural Sleeve without electrical stimulation. The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the Neural Sleeve to those measured by the gait mat. During the walking trials, participants will be told that they can take a break if needed. Condition order will be randomized and participants will be offered 5 minutes of rest between consecutive trials. Validity of gait metrics of the Neural Sleeve will be compared against the Zeno walkway.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons between the ages of 22-64
  • Ability to ambulate at least 30 minutes during a two-hour period

Exclusion criteria

  • Lower motor neuron disease or injury (e.g. peripheral neuropathy)
  • Absent sensation in the legs
  • Demand-type cardiac pacemaker or defibrillator
  • Malignant tumor in the legs
  • Existing thrombosis in the legs
  • History of lower limb injury or orthopedic issues leading to impaired walking

Treatment and study plan

Neural Sleeve and Zeno walkway

Device

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.

Primary outcomes

  1. Gait speed

    Time frame: A walking session of up to 5 minutes

    Time one takes to walk a specified distance (expressed as a ratio between distance and time, in centimeters per second)

  2. Stride length

    Time frame: A walking session of up to 5 minutes

    Distance (centimeters) covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel) (centimeters)

  3. Cadence

    Time frame: A walking session of up to 5 minutes

    Number of steps per minute (steps per minute)

Sponsors and collaborators

Lead sponsor

Cionic, Inc.

Industry

Registry information

Official study title

Validation of Gait Metrics From Cionic Neural Sleeve

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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