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

Sponsor
University Hospital, Ghent
Study ID
NCT07237386
Status
Recruiting
Apply to this trial

Conditions

  • Acquired Brain Injury
  • Incomplete Spinal Cord Injury
  • Stroke
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wearing smart insoles — DEVICE
    Participants will wear Ceriter Stride One insoles during walking on an instrumented treadmill. Parameters (like stance phase duration and swing phase duration) measured by the insoles will be compared to the same parameters measured by the instrumented treadmill with accompanying 3D motion capture system.

Study Details

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.

Key Dates

First listed
Nov 19, 2025
Start date
Oct 15, 2025
Status verified
Nov 2025
Primary completion
Sep 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Insoles
    This is the group wearing smart insoles, it is the only group

Primary Outcome Measure

Swing phase as a percentage of the duration of one stride [ Time Frame: Single point of assessment at inclusion ]

Central Contacts

Find similar trials

Nationwide
Stroke trialsNeurology trialsBrain disorders trials

Related Studies