Actively Recruiting

Phase Not Applicable
All Genders
NCT07237386

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

Led by University Hospital, Ghent · Updated on 2025-11-19

30

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

U

University Ghent

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persons with a lesion of the central nervous system (stroke, incomplete spinal cord injury, acquired brain injury) admitted to or receiving outpatient therapy at the Ghent University hospital rehabilitation center
  • Able to walk independently for at least 6 minutes without assistance (Functional ambulation category 3 or higher)
Not Eligible

You will not qualify if you...

  • Severe orthopedic trauma or acute trauma of the lower limbs affecting walking
  • Body weight exceeding 120 kg
  • Severe dizziness preventing exercise in standing position
  • Severe cardio-pulmonary disorders requiring monitoring during exercise
  • Unable to understand the tasks required in this study

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Ghent

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

A

Anke Van Bladel, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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