StrokeNCT07237386
Comparing the Ceriter Stride One, a Pressure-sensitive Smart Insole, With Gait Parameters Measured on the GRAIL in Neurological Populations
A study testing Wearing smart insoles in people with Stroke and Incomplete Spinal Cord Injury, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Incomplete Spinal Cord Injury, Traumatic Brain Injury
- What is being tested?
- Wearing smart insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Anke Van Bladel, +32 9 332 12 43, Anke.VanBladel@uzgent.be
About this study
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.
Read more
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.
- Being tested
- Wearing smart insoles
- Keywords
- Gait, stroke, spinal cord injury, brain injury, smart insoles, spatiotemporal
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Brain Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing smart insolesDevice
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 group | Role | What they receive |
|---|---|---|
| Insoles | Experimental | This is the group wearing smart insoles, it is the only group Receives: Device: Wearing smart insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swing phase as a percentage of the duration of one stride
For each leg the duration of the swing phase will be determined as a percentage of the duration of one stride. Using the GRAIL system this will be calculated as de duration between toe-off and the following heel contact of the same leg. Using the ceriter stride one insole this will be calculated by determining the toe-off and following heel contact based on a cut-off value using the pressure sensors in the insole. For both devices it will be expressed as a percentage of the duration of one stride.
Measured: Single point of assessment at inclusion
Stance phase as a percentage of the duration of one stride
For each leg the duration of the stance phase will be determined as a percentage of the duration of one stride. Using the GRAIL system this will be calculated as de duration between heel contact and the following toe-off of the same leg. Using the ceriter stride one insole this will be calculated by determining the heel contact and following toe-off based on a cut-off value using the pressure sensors in the insole. For both devices it will be expressed as a percentage of the duration of one stride.
Measured: Single point of assessment at inclusion
Secondary outcomes (4)
Stance phase as a percentage of the duration of one stride after 5 weeks
For each leg the duration of the stance phase will be determined as a percentage of the duration of one stride. Using the GRAIL system this will be calculated as de duration between heel contact and the following toe-off of the same leg. Using the ceriter stride one insole this will be calculated by determining the heel contact and following toe-off based on a cut-off value using the pressure sensors in the insole. For both devices it will be expressed as a percentage of the duration of one stride.
Measured: Single point of assessment at 5 weeks after inclusion
Swing phase as a percentage of the duration of one stride after 5 weeks
For each leg the duration of the swing phase will be determined as a percentage of the duration of one stride. Using the GRAIL system this will be calculated as de duration between toe-off and the following heel contact of the same leg. Using the ceriter stride one insole this will be calculated by determining the toe-off and following heel contact based on a cut-off value using the pressure sensors in the insole. For both devices it will be expressed as a percentage of the duration of one stride.
Measured: Single point of assessment at 5 weeks after inclusion
Ratio of stance phase duration
The ratio of the stance phase duration of the paretic leg will be calculated compared to the non-paretic leg. Or if both legs are involved, the ratio of the most impaired leg on the least impaired leg. This will determine the asymmetry in stance phase duration during walking.
Measured: Single point of assessment at inclusion
Ratio of stance phase duration after 5 weeks
The ratio of the stance phase duration of the paretic leg will be calculated compared to the non-paretic leg. Or if both legs are involved, the ratio of the most impaired leg on the least impaired leg. This will determine the asymmetry in stance phase duration during walking.
Measured: Single point of assessment at 5 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Oct 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237386
- Sponsor's protocol ID
- ONZ-2025-0386
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Ceriter Stride One, a Pressure-sensitive Smart Insole, With Gait Parameters Measured on the GRAIL in Neurological Populations
- ClinicalTrials.gov ID
- NCT07237386
- Acronym / sponsor ID
- ONZ-2025-0386
- Keywords
- Gait, stroke, spinal cord injury, brain injury, smart insoles, spatiotemporal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insoles | Experimental | Device: Wearing smart insolesThis is the group wearing smart insoles, it is the only group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing smart insolesParticipants 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. | Device | Insoles |
Primary outcome
Swing phase as a percentage of the duration of one stride
Time frame: Single point of assessment at inclusion
For each leg the duration of the swing phase will be determined as a percentage of the duration of one stride. Using the GRAIL system this will be calculated as de duration between toe-off and the following heel contact of the same leg. Using the ceriter stride one insole this will be calculated by determining the toe-off and following heel contact based on a cut-off value using the pressure sensors in the insole. For both devices it will be expressed as a percentage of the duration of one stride.
Stance phase as a percentage of the duration of one stride
Time frame: Single point of assessment at inclusion
For each leg the duration of the stance phase will be determined as a percentage of the duration of one stride. Using the GRAIL system this will be calculated as de duration between heel contact and the following toe-off of the same leg. Using the ceriter stride one insole this will be calculated by determining the heel contact and following toe-off based on a cut-off value using the pressure sensors in the insole. For both devices it will be expressed as a percentage of the duration of one stride.
4 secondary outcomes
Stance phase as a percentage of the duration of one stride after 5 weeks
Time frame: Single point of assessment at 5 weeks after inclusion
Swing phase as a percentage of the duration of one stride after 5 weeks
Time frame: Single point of assessment at 5 weeks after inclusion
Ratio of stance phase duration
Time frame: Single point of assessment at inclusion
Ratio of stance phase duration after 5 weeks
Time frame: Single point of assessment at 5 weeks after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing smart insoles in people with Stroke and Incomplete Spinal Cord Injury, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anke Van Bladel, Professor (+32468181632, anke.vanbladel@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swing phase as a percentage of the duration of one stride (time frame: Single point of assessment at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.