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

Обзор

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.

Вмешательства

• Устройство Wearing smart insoles
  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.

Первичные конечные точки

• Swing phase as a percentage of the duration of one stride [Срок оценки: Single point of assessment at inclusion]
• Stance phase as a percentage of the duration of one stride [Срок оценки: Single point of assessment at inclusion]

Вторичные конечные точки (4)

• Stance phase as a percentage of the duration of one stride after 5 weeks [Срок оценки: Single point of assessment at 5 weeks after inclusion]
• Swing phase as a percentage of the duration of one stride after 5 weeks [Срок оценки: Single point of assessment at 5 weeks after inclusion]
• Ratio of stance phase duration [Срок оценки: Single point of assessment at inclusion]
• Ratio of stance phase duration after 5 weeks [Срок оценки: Single point of assessment at 5 weeks after inclusion]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Бельгия · 1 центр

• University Hospital Ghent — Ghent

Идентификаторы

NCT: NCT07237386 · ONZ-2025-0386

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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