Validation of the Cionic Neural Sleeve gait metrics
Validation of Gait Metrics From Cionic Neural Sleeve
This study is testing how well the Cionic Neural Sleeve measures walking compared to a standard walking measurement system, using healthy adults to see if it gives accurate results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 22 Years to 64 Years |
| Sex | All |
| Sponsor | Cionic, Inc. Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06503354 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the gait metrics provided by the Cionic Neural Sleeve by comparing them to established measurements obtained from the Protokinetics Zeno pressure sensitive walkway. Healthy adult volunteers will wear the Neural Sleeve on their dominant leg while performing walking trials on the Zeno walkway. The study will assess the accuracy of the Neural Sleeve's motion data against the 'gold standard' gait parameters from the Zeno walkway, providing insights into the reliability of the device's metrics. Participants will engage in multiple walking conditions, allowing for a comprehensive evaluation of the device's performance.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 22-64 who can walk for at least 30 minutes within a two-hour period.
Not a fit: Patients with lower motor neuron diseases, absent sensation in the legs, or significant orthopedic issues affecting walking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the confidence of users in the accuracy of the Neural Sleeve's gait reports, leading to better-informed usage and monitoring of gait changes over time.
How similar studies have performed: While this study focuses on validating a specific device, similar validation studies have shown success in confirming the accuracy of gait metrics in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- Cleveland State University, Department of Health Sciences and Human Performance — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Douglas Wajda, PhD
- Email: d.a.wajda@csuohio.edu
- Phone: 216-687-4870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.