Gait Metric Validation of the Cionic Neural Sleeve

Recruiting

• Conditions: Validation Study
• Interventions: Device: Neural Sleeve and Zeno walkway

• Registration Number: NCT06503354
• Lead Sponsor: Cionic, Inc.

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 innaccuracy 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.

Detailed Description

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 walking conditions. Overall, participants will perform three, 5 minute walking bouts without electrical stimulation. Two walking conditions will be performed while wearing the Neural Sleeve, however, no electrical stimulation will be utilized. The movement sensors on the Neural Sleeve will collect motion data that permits the comparison of gait metrics from the 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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study Start: 2024-07-08
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Neural Sleeve and Zeno walkway	Healthy adults

Primary Outcome Measures

Name	Time	Method
Cadence	A walking session of up to 5 minutes	Number of steps per minute (steps per minute)
Gait speed	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)
Stride length	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)

Trial Locations

Locations (1)

Cleveland State University, Department of Health Sciences and Human Performance; 🇺🇸 Cleveland, Ohio, United States