Study design and study sample
This prospective cohort study was approved by the local ethics committees of the University Hospital Leuven in collaboration with Ziekenhuis Oost-Limburg (Genk) and Jessa Hospital (Hasselt, Belgium) (S59857). The cross-sectional analysis consisted of 20 people with unilateral end-stage hip OA, 18 people with unilateral end-stage knee OA and 20 asymptomatic controls. The inclusion and exclusion criteria are described in Table 1. The eighteen people with knee OA were treated with a TKA, and 17 were re-evaluated at six weeks, three months, six, and 12 months postoperatively (Figure 1). One participant dropped out due to a herniated disc with functional impairment. This study is a secondary analysis of a larger project (S59857) that evaluated the hip and knee joint contact forces in people with degenerative joint disorders and following a total joint arthroplasty. For that study, the sample size was based on the compartmental forces measured in subjects with an instrumental knee prosthesis (1.61 +/-0.305 body weight during gait[27]). Assuming that a change in contact forces of one standard deviation to be significant and to achieve a power of 0.8, a sample of 14 subjects was required. Taking a possible 15-20% loss of participants into account during the follow-up, we recruited 18 to 20 participants per cohort.
Data acquisition
We placed a single tri-axial IMU (MVN BIOMECH Awinda, Xsens Technologies, sampling at 60 Hz[28]) with a 3D accelerometer at the level of L5/S1 using double-sided tape. We used an additional Velcro strap around the participant’s waist to further secure the IMU and minimise excessive movement. Subjects were instructed to walk at self-selected speed in a straight line of 10m across our movement laboratory (MALL, KUL, Belgium) at different
Table 1
Inclusion and exclusion criteria for the participants
Healthy population
|
Patient population
|
Inclusion
- Aged between 50 – 75 years old
- Understand the Dutch language
- Able to walk 10m and ascent/descent the stairs
|
Inclusion
- Aged between 50 – 75 years old
- Diagnosed with hip or knee OA
- Awaiting of total hip of knee replacement surgery
- Understand the Dutch language
- Able to walk 10m and ascent/descent the stairs
|
Exclusion
- Diagnosed with musculoskeletal or neurological disorders
- Pain in hips, knees or ankles, which affect normal movement
|
Exclusion
- Corticosteroid injection 3 months before inclusion to the study
- Joint replacement in other lower limb joints
- Diagnosed with symptomatic hip or knee OA on the contralateral knee
- Symptomatic degenerative disorders in other lower limb joints
- Neurological conditions that could alter movement pattern
- History of pathological osteoporotic fractures (in hip, knee or ankle joints)
|
evaluation points. People with hip OA were only measured once (pre-THA), and the people with knee OA were evaluated five times (pre-TKA, six weeks, three months, six, and 12 months post-TKA) (see Figure 1). The asymptomatic controls returned to the MALL for a re-evaluation. We used the data from asymptomatic controls to calculate the minimal detectable change using the interclass correlation coefficient (ICC) of the movement quality parameters. The Hip disability (Hip OA subjects) and Knee injury Osteoarthritis Outcome Score (Knee OA and Asymptomatic subjects) (HOOS and KOOS) were completed to evaluate patient reported outcome measures. Figure 1 gives the flow of the data collection and the number of participants measured at each time instance.
Data processing
For each walking trail, the sensor tilt was corrected to convert the accelerations from the local sensor XYZ-coordinate system to the global anterior-posterior (AP), vertical (VT), and mediolateral (ML) coordinate system[29]. After that, the AP and ML accelerations were used to identify the individual left and right steps[14]. The steady-state steps[30] were extracted and concatenated to create one long, continuous time series[31]. Considering that the stability and complexity measures are sensitive to the time series length used as input, we used a fixed-step approach to establish the length of the time-series[32]. We determined the least number of steps taken by the participants and truncated the signal length of all other participants to that number of steps (n=47 which corresponds to +/- 1500 samples).
Movement quality was then evaluated in terms of: (1) movement symmetry, (2) local dynamic stability (3) movement complexity, and (4) movement smoothness. First, movement symmetry was quantified as step and stride regularity. These were calculated using the first two dominant peaks after the zero phase of the unbiased autocorrelation with perfect symmetry equal to one[15]. Since a cyclic signal will produce an autocorrelation with peak values with a time lag equivalent to the period of the signal, the first and second dominant peak represents phase shifts equal to one step and one stride, respectively[15]. The unbiased autocorrelation
signal was normalised to equal one at zero phase shift. Therefore, the height of the first dominant peak shows the autocorrelation coefficient between consecutive steps, and the height of the second dominant peak the autocorrelation coefficient between consecutive strides and is therefore considered a symmetry index. Since ML trunk accelerations produce both positive and negative values representing left-right trunk sway, step regularity in ML direction are always negative. Therefore, the absolute values are used for analysis. In both cases, lower values of the autocorrelation coefficient indicate more asymmetry.
In the second category, local dynamic stability was calculated by estimating the short-term and long-term maximum Lyapunov Exponent (LyE λS and LyE λL, respectively). The LyE captures how a system responds to perturbations by calculating the divergence of nearest neighbours in state spaces using Rosenstein’s method[33] and as proposed by Bruijn et al. (2010)[34]. For the calculation of the LyE, we set the embedding dimension to 5[34]. The time delay was calculated per subject as the decrease in the autocorrelation curve of 1-1/e as this retained the smallest errors[33]. LyE is calculated over two time-increments: LyE λS over 0-0.5 strides and LyE λL over 4-10 strides. The λS indicates how well the systems deal with perturbations at the step or stride level, whereas λL evaluates how the system is able to handle perturbations over the time increment of several strides. Higher values indicate lower dynamic stability[34,35], indicating an unstable gait pattern with a higher risk of falling[35].
The third and fourth categories are the movement complexity and movement smoothness measure; these are quantified as sample entropy and log dimensionless jerk (LDLJ-A), respectively. Sample entropy captures waveform predictability with higher values indicating less periodicity, thus, more unpredictability[36]. We used nonlinear mathematical algorithms previously described by Richman and Moorman (2000)[37]. As input for the calculation of the sample entropy we used the time series sample length (N) corresponding to the least number of steps taken as described previously, the series length (m) of 2 data points, and a tolerance window (r) normalised to 0.2 times the standard deviation of the timeseries[36].
LDLJ-A assesses movement smoothness by quantifying the changes in the acceleration signal (jerk—a derivative of the acceleration signal) as proposed by Melendez-Calderon et al. (2021)[38]. The Euclidean norm (2-norm) of the acceleration signals (i.e., Pythagorean Theorem over acceleration in VT, ML, and AP direction) was used to calculate the LDLJ-A over each step separately, thereafter the average was calculated to obtain a single smoothness measure per subject. A signal that shows minimal changes in the acceleration and deceleration pattern is considered smoother. A smoother movement is indicated by lower values[22].
All data were processed and analysed using customised MATLAB scripts (MATLAB 2018b, The Math Works, Inc. Natick, Massachusetts, USA).
Statistical analysis
Data were not normally distributed as assessed by visual inspection of the histogram, Q-Q plot, and Shapiro-Wilk test. Therefore, non-parametric statistics were used. We used the Mann-Whitney U test for group differences between asymptomatic controls and people with hip OA and between asymptomatic controls and people with knee OA. The Minimal Detectable Change (MDC) per dependent variable was calculated using data from the test-retest of all asymptomatic controls using the interclass correlation coefficient (ICC(3,k))[39]. The MDC was calculated to check whether a difference between the two cohorts is a fundamental difference that surpasses the system’s measurement errors.
To assess how the parameters evolve after a TKA, Friedman’s chi-square ANOVA was conducted. When a significant main effect was found (α<0.05), a Wilcoxon signed-rank test with a Bonferroni correction (α<0.005) was calculated to test for differences between timepoints. A spearman’s rho correlation coefficient was calculated on the change scores between 6 weeks and 12 months post-op to relate changes in movement quality to patient-reported functioning, symptoms, and quality of life. A spearman’s rho correlation coefficient between 0-0.25 was considered low, from 0.25-0.5 fair, 0.5-0.75 moderate, and 0.75-1.0 high. Statistical analysis was performed using Python SciPy statistics package (v1.4.1) and missing data were omitted[40].
This resulted in preoperative cohorts of 20 asymptomatic controls, 18 people with knee OA and 20 people with hip OA. Seventeen people post-TKA were included in the follow-up analysis (one drop-out at 12 months) and in the correlation analysis between movement quality and patient reported pain, symptoms, ADL, and QOL. The correlation analyses of patient reported sports/recreation was on 15 people (drop-out of 3 due to an inability to answer the questionnaire).