View clinical trials related to Reproducibility.
Filter by: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.
This study will combine Duffin's rebreathing procedure with additional study procedures, such as quantitative pupillometry, that are planned for subsequent clinical studies in order to confirm feasibility and gather reproducibility data using the procedure. The reproducibility of Duffin rebreathing has been assessed previously by Mahamed and Duffin (2001) performing hyperoxic and hypoxic rebreathing procedures measured once daily for 14 consecutive days and then by Jensen et al. (2010) performing 4 pairs of hyperoxic and hypoxic rebreathing procedures in 1 day followed by 1 pair on 4 additional days separated by weeks to more than a month. The present study is an unblinded reproducibility assessment to assess variability of the ventilatory response to Duffin's rebreathing procedure. Subjects will report to the study site for screening between Days -28 to -2 and then will return to the site on Day -1 for baseline assessments and check-in. After check-in (Day -1), subjects will remain in study site for PD assessments on Day 1 and check out on Day 2. Paired rebreathing procedures (i.e., at two different isoxic end tidal PO2 [partial pressure oxygen] levels) will be performed on Day 1 at 0, 2, 4, and 6 hours. An additional pair of rebreathing procedures will be performed on Day 2 before checkout (approximately 24 hours). Subjects will not be administered any drugs in this study.