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临床试验/NCT05530213
NCT05530213招募中不适用

Interlaboratory Reliability of 3D Gait Analysis Performed on an Instrumented Treadmill.

University Ghent2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2022年10月1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
2
主要终点
3D lower limb kinematics (angles °)

研究概览

简要总结

The purpose of this study is to determine the interlaboratory reliability of 3D gait analysis performed on healthy subjects on an instrumented treadmill in three different laboratories. This will allow us to evaluate whether the pooling of control data is feasible in future studies. This will support our ambitions to enter into future collaborations to conduct studies with larger samples. Moreover, this way we will know if we can share patient data in the future so that patients can be specifically referred to a lab with expertise on a particular evaluation, e.g. the lab in Maastricht has expertise on perturbations, UZ Gent has expertise on full-body measurements and UHasselt has expertise on balance.

During this study approximately 30 healthy subjects will be recruited (10 from each center) from the staff and students at each center. These subjects are own staff and students of the 3 centers. Each subject will undergo a 3D gait analysis at each center (at UZGent, UHasselt and UMaastricht). Therefore, each subject will be evaluated 3 times. The time between each evaluations will be a maximum of one week.

The evaluations will be performed as per standard procedure in each lab. However, a standardized model (HBM2 lower limb), an agreed walking velocity (0.9 m/s, 1.0 m/s, 1.1 m/s) and an agreed duration per recording (3 min) will be used. The same software will be used to process the collected data. 3D kinematics and kinetic time-series data of the lower limbs will be extracted as outcome data. Absolute reliability indices will be calculated in the following way: First, the standard deviation (SD) of time-series data across different gait cycles will be calculated per participant per center. The SD values across different centers per participant will then be averaged. Finally, the SD values across different participants will form the inter-laboratory reliability indices. In addition, we will use statistical parametric mapping (Anova repeated measures) to compare the full time-series data of each outcome parameter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Data analysis will be carried out by investigators who are blind to the location of where the data was collected.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy subjects aged 18-65 years old

排除标准

  • •Individuals cannot participate if:
  • •They suffer from a neurological disorder.
  • •They experience balance problems.
  • •They have had surgical procedures on the legs in the past.
  • •They are taking medication that may affect gait and balance. They experience leg or back pain at the time of test taking.

研究组 & 干预措施

Healthy adults UZ Gent

Experimental

A group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UZ Gent within a week of the 3D gait analysis at UHasselt and/or UMaastricht.

干预措施: Weight and height (Other)

Healthy adults UZ Gent

Experimental

A group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UZ Gent within a week of the 3D gait analysis at UHasselt and/or UMaastricht.

干预措施: 3D gait analysis on the GRAIL (Device)

Healthy adults UHasselt

Experimental

The same group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UHasset within a week of the 3D gait analysis at UZGent and/or UMaastricht.

干预措施: 3D gait analysis on the GRAIL (Device)

Healthy adults UHasselt

Experimental

The same group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UHasset within a week of the 3D gait analysis at UZGent and/or UMaastricht.

干预措施: Weight and height (Other)

Healthy adults UMaastricht

Experimental

The same group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UHasset within a week of the 3D gait analysis at UZGent and/or UZGent.

干预措施: 3D gait analysis on the GRAIL (Device)

Healthy adults UMaastricht

Experimental

The same group of 30 healthy adults aged 18-65years old will carry out a 3D gait analysis at UHasset within a week of the 3D gait analysis at UZGent and/or UZGent.

干预措施: Weight and height (Other)

结局指标

主要结局

3D lower limb kinematics (angles °)

时间窗: Single point of assessment in one day

Marker trajectory data is collected during the 3D gait analysis and lower limb kinematics are calculated in post-processing. Pelvis, hip, knee and ankle angles will be assessed during walking at 3 different gait velocities

3D lower limb kinetics (Nm/kg)

时间窗: Single point of assessment in one day

Force plate data is collected during the 3D gait analysis and hip, knee and ankle kinetics are calculated while walking at 3 different gait velocities.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Interlaboratory Reliability of 3D Gait Analysis | 临床试验