Gait Metric Validation of the Cionic Neural Sleeve

NCT06503354 | Completed FDA Device

• 1 other identifier: IRB-FY2024-253
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Gait speed

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

  A walking session of up to 5 minutes

• Stride length

  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)

  A walking session of up to 5 minutes

• Cadence

  Number of steps per minute (steps per minute)

  A walking session of up to 5 minutes

Study Arms (1)

Participants

Healthy adults

Device: Neural Sleeve and Zeno walkway

Interventions

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.

Participants

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cionic, Inc.: lead

Study Sites (1)

Cleveland State University, Department of Health Sciences and Human Performance

Cleveland, Ohio, 44115-2214, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 16, 2024
• Study Start: July 8, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 11, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)