RECRUITING

Gait Metric Validation of the Cionic Neural Sleeve

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Validation of Gait Metrics From Cionic Neural Sleeve

Quick Facts

Study Start:2024-07-08
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06503354

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.

Ages Eligible for Study:22 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Persons between the ages of 22-64
  2. * Ability to ambulate at least 30 minutes during a two hour period
  1. * Lower motor neuron disease or injury (e.g. peripheral neuropathy)
  2. * Absent sensation in the legs
  3. * Demand-type cardiac pacemaker or defibrillator
  4. * Malignant tumor in the legs
  5. * Existing thrombosis in the legs
  6. * History of lower limb injury or orthopedic issues leading to impaired walking

Contacts and Locations

Study Contact

Douglas Wajda, PhD
CONTACT
216-687-4870
d.a.wajda@csuohio.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Cionic, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-08
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-07-08
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Validation Study