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临床试验/NCT07237386
NCT07237386招募中不适用

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

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Swing phase as a percentage of the duration of one stride

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •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.

研究组 & 干预措施

Insoles

Experimental

This is the group wearing smart insoles, it is the only group

干预措施: Wearing smart insoles (Device)

结局指标

主要结局

Swing phase as a percentage of the duration of one stride

时间窗: 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

时间窗: 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.

次要结局

  • Stance phase as a percentage of the duration of one stride after 5 weeks(Single point of assessment at 5 weeks after inclusion)
  • Swing phase as a percentage of the duration of one stride after 5 weeks(Single point of assessment at 5 weeks after inclusion)
  • Ratio of stance phase duration(Single point of assessment at inclusion)
  • Ratio of stance phase duration after 5 weeks(Single point of assessment at 5 weeks after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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