Comparing Ceriter Stride-One smart insoles with GRAIL gait measurements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Ghent
  Ghent, Belgium Recruiting

Study contacts

• Study coordinator: Anke Van Bladel, Professor
• Email: anke.vanbladel@uzgent.be
• Phone: +32468181632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.