RECRUITING

Gait Metric Validation of the Cionic Neural Sleeve

Description

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.

Study Overview

Study Details

Study overview

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.

Validation of Gait Metrics From Cionic Neural Sleeve

Gait Metric Validation of the Cionic Neural Sleeve

Condition
Validation Study
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland State University, Department of Health Sciences and Human Performance, Cleveland, Ohio, United States, 44115-2214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

22 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Cionic, Inc.,

Study Record Dates

2024-12-31