NCT07237386

Comparing the Ceriter Stride One, a Pressure-sensitive Smart Insole, With Gait Parameters Measured on the GRAIL in Neurological Populations

Recruiting now NA Last updated 19 November 2025

What this trial tests

NA trial testing Wearing smart insoles in Stroke in 30 participants. Currently enrolling.

Timeline

15 October 2025

Primary endpoint
1 September 2026

1 October 2026

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	15 October 2025
Primary completion	1 September 2026
Estimated completion	1 October 2026
Sites	1 location across Belgium

Drugs / interventions tested

• Wearing smart insoles

Conditions studied

• Stroke — all drugs for Stroke →
• Incomplete Spinal Cord Injury — all drugs for Incomplete Spinal Cord Injury →
• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
• Acquired Brain Injury — all drugs for Acquired Brain Injury →

Sponsor

University Hospital, Ghent

Who can join

Eligibility, any sex, with Stroke or Incomplete Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ceriter Stride-One soles have been available on the market for several years. One of the features of these soles is that they can measure gait parameters while patients walk around in a functional environment. This can provide a more realistic picture of gait patterns compared to measurements taken in a laboratory setting.

At UZ Ghent, we use an advanced gait lab to measure gait parameters before and after a training period on this system, the GRAIL system. We measure similar parameters to the Ceriter Stride-One soles (support phase, swing phase, pressure on the left leg and on the right leg). In this study, we would apply these insoles to patients who are tested on the GRAIL system, according to standard care, during the test in order to compare the parameters measured by the insoles and the parameters measured by the GRAIL system. This information will give us more insight into the accuracy of the data measured with these soles so that we can apply them in future studies conducted not in the gait lab but in functional environments.

Patients who are eligible for GRAIL therapy and are therefore routinely tested are patients who are admitted or undergoing outpatient rehabilitation at the rehabilitation centre of UZ Ghent after a brain injury, stroke, spinal cord injury or amputation. Given the subject of the research and the difficulty of fitting a sole into the shoe of a prosthetic leg, only people with brain and spinal cord injuries are asked to participate in the study.

Participants must be able to step onto the GRAIL treadmill with the help of one therapist and must be able to walk for at least six minutes. Participants have to weigh less than 120 kg (treadmill safety system restriction).

As standard in our setting, participants train for 5 weeks, twice a week for 30 minutes on the GRAIL treadmill. Before and after their training period, they walk on the GRAIL for about 2 minutes and we measure a number of gait parameters: speed, step width, step length, duration of the support phase and swing phase, and how much they support on their left and right legs.

Some of these parameters can also be measured by the Ceriter Stride One sole. The aim is to investigate how comparable these data are. If these data are sufficiently comparable, the soles can be used to measure the ratio of the support and swing phases during walking in everyday tasks or in environments other than a laboratory setting.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.