Comparing Ceriter Stride-One smart insoles with GRAIL gait measurements
Comparing the Ceriter Stride One, a Pressure-sensitive Smart Insole, With Gait Parameters Measured on the GRAIL in Neurological Populations
We will test whether Ceriter Stride-One pressure-sensitive insoles give the same gait measurements as the GRAIL system for people with stroke, incomplete spinal cord injury, or acquired/traumatic brain injury who can walk independently for at least six minutes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07237386 on ClinicalTrials.gov |
What this trial studies
Participants who are in rehabilitation for stroke, incomplete spinal cord injury, or acquired/traumatic brain injury will wear Ceriter Stride-One smart insoles while undergoing standard gait assessment on the GRAIL instrumented treadmill at UZ Ghent. The study will compare matching parameters such as support phase, swing phase, and left/right leg pressure recorded by the insoles and the GRAIL. Agreement between the two measurement systems will be analyzed to determine the insoles' accuracy. Results will inform whether these insoles can be used reliably in clinical practice and future outpatient or real-world gait monitoring studies.
Who should consider this trial
Good fit: Adults with central nervous system lesions (stroke, incomplete spinal cord injury, or acquired/traumatic brain injury) receiving care at the Ghent rehabilitation center who can walk independently for at least six minutes are ideal candidates.
Not a fit: Patients with severe lower-limb orthopedic trauma, body weight over 120 kg, severe dizziness or cardiopulmonary disorders that prevent safe standing/exercise, or who cannot understand the task are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, validated insoles could provide accurate, real-world gait data outside the lab to guide personalized rehabilitation and remote monitoring.
How similar studies have performed: Previous studies of wearable pressure insoles have shown reasonable agreement with lab-based gait systems in some populations, but validation specifically in these neurological rehabilitation groups is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persons suffering a lesion of the central nervous system (stroke, incomplete spinal cord injury, acquired brain injury) who are admitted to the rehabilitation center of the Ghent University hospital or who follow therapy at the rehabilitation center of the Ghent University hospital as outpatients. * Patients need to be able to walk independently during at least 6 minutes without the need of an extra person (Functional ambulation category 3 or higher). Exclusion Criteria: * Severe orthopedic trauma or acute trauma of the lower limbs influencing walking * body weight that exceeds 120 kg. * severe dizziness that makes exercising in standing position impossible * severe cardio-pulmonary disorders that require monitoring during exercising * patients who do not understand the task that needs to be performed in this study.
Where this trial is running
Ghent
- University Hospital Ghent — Ghent, Belgium (Recruiting)
Study contacts
- Study coordinator: Anke Van Bladel, Professor
- Email: anke.vanbladel@uzgent.be
- Phone: +32468181632
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.