Participants
This cross-sectional study was conducted in accordance with the Declaration of Helsinki. Each participant was given a written informed consent and the study protocol was approved by our ethical committee (#20190294).
To develop the AI system and to validate its reliability, we had two different gait studies and enrolled different subjects for each gait study. In the first gait study, simultaneous measurements of 3D motion capture and IMU were performed. In the second gait study, gait analysis using IMU and AI system was performed.
AI development (Gait study 1)
We recruited patients who visited our outpatient clinic from March 2017 to February 2022 and were diagnosed with KOA by an orthopedic surgeon who has more than 30 years clinical experience in treatment of KOA. Patients with any symptoms in either the hip or the ankle joint were excluded from the study. Patients with any disorders that affect gait activity such as rheumatoid arthritis and lumbar spinal stenosis were also excluded. A total of 46 KOA patients and 14 asymptomatic subjects (50 females and 10 males) were enrolled in the present study. Mean age was 62.9 (12.8) years old and mean Body Mass Index (BMI) was 22.3 (3.3) kg/m. In this study, the radiographic findings of knee joint were evaluated on the basis of the Kellgren-Lawrence (KL) classification [19]. The patients with KL grade 0 showed no symptoms, and KL grade 1 showed symptoms such as pain or stiffness in the knee joint and tenderness or crepitus at the medial joint line without obvious joint space narrowing or osteophyte on radiographs, and the patients with KL grade 2 or higher showed obvious radiological changes and were defined as medial knee OA [19,20]. A total of 115 knees were involved and 5 knees were excluded because of having total knee replacement previously, and 28,27,26,26 and 8 knees were allocated to the KL grade 0,1,2,3, and 4 respectively on plain radiographs. (Table 1)
Reliability of the AI system (Gait study 2)
A total of 40 knee joints; 24 knees of 12 OA patients (8 females 4 males) and 16 knees of 8 asymptomatic subjects (7 females 1 males) were enrolled to evaluate the intra- and inter-rater reliabilities of the AI system. Mean age was 61.3 (10.1) years old and mean Body Mass Index (BMI) was 23.2 (4.3) kg/m2. A total of 15,9,12,3 and 1 knees were allocated to the KL grade0,1,2,3 and 4, respectively.
Testing Procedure
AI development (Gait study 1)
To generate deep learning protocol, gait data from simultaneous measurements of 3D motion capture system and IMU were obtained. A 3D motion capture system consisting of eight cameras (200 frames/second; Oqus, Qualisys, Sweden) and two force plates (frequency 2000 Hz; AM6110, Bertec, Colum-bus, OH, USA) were used. The force plates were synchronized to the sampling rate of the camera (200 Hz). In addition, two IMU sensors were fixed to the bilateral tibial tubercle with a strapped band. The IMU sensors used in this study was a commercial IMU (TSND151, ATR-Promotions, Kyoto, Japan) at the same sampling rate (200 Hz). The data from the IMU (3-axis accelerations, 3-axis angular accelerations, and 3-axis gyroscopes) were recorded on a laptop computer using a commercial soft-ware (SensorController, ATR-Promotions, Kyoto, Japan). After several practice trials, subjects performed 6 to 10 trials of a 5m walk at a self-selected speed in the gait laboratory. (Figure 1) Marker movements were recorded with Qualisys Track Manager software (version 2.7). Visual 3D (C-motion, Rockville, MD, USA) was used for knee joint kinematic and kinetic calculations. The first peak value of KAM in the stance phase was defined as KAM peak, and KAM impulse, the timed integral of all the KAMs was calculated for stance duration.
Figure 1 Experimental set up for simultaneous measurement of 3D motion capture and IMUs
Figure 2 shows the overview of our algorithm. Our algorithm comprises two main components. The input consists of a six-dimensional sequence formed by acceleration and angular velocity, which is preprocessed through a band-pass filter allowing only components ranging from 1Hz to 16Hz to pass. Subsequently, gait phase detection is conducted as illustrated on the left side of Figure 2. The process of gait phase detection unfolds as follows: (1) detection of local maxima and minima; (2) pairing consecutive local minima and maxima (indicated by the red squares in Figure 2). This pattern marks the final stage of the swing phase in each gait cycle and is utilized to define the gait cycle, denoted by the red numbers in Figure 2. The gait cycles detected in the area subsequently defined as Regions of Interest (ROI), and the original input sequence is cropped to exclusively incorporate these identified periods. [10] The cropped sequence is then fed into a one-dimensional Convolutional Neural Network (CNN) model, which ultimately outputs the predicted values after passing through a Generalized Mean (GeM) pooling [21] layer. The KAM peak prediction model adopts a broad kernel size of 31, resulting in a total parameter count of 3986. The impulse prediction model adopts a wider kernel size of 45, culminating in a total parameter count of 17314.
Overall, Total of 3 accelerations and 3 angular velocities about 3 orthogonal axis from IMU sensers during the stance phase were matched with KAM data (peak and impulse) obtained by 3D motion capture simultaneously. Gait data of 121 randomly extracted trials were used as training data, and a deep learning model based on 5-fold cross validation to match KAM using those accelerations and angular velocities was created. Finally, acceleration parameter (iKAM) was calculated based on the deep learning algorithm. A peak iKAM (iKAM_peak) and impulse of iKAM (the timed integral of all the iKAM: iKAM_impulse) that correspond to the KAM peak and KAM impulse were calculated and evaluated.
Figure 2. The overview of our algorithm.
Acc: acceleration, ω: angular velocity, ROI: region of interest, Conv: convolution layer, ReLU: rectified linear unit, GeM: generalized mean.
The accuracy of the AI
The accuracy of the AI system was evaluated by comparing true KAM peak and KAM impulse, and iKAM_peak and iKAM_impulse, both on the train dataset (121 gait data from 35 subjects) and the test dataset (31 gait data from 9 subjects) that were randomly chosen from the whole gait data.
Reliability evaluation (Gait study 2)
The intra- and inter-observer reliabilities of the AI system was evaluated using gait data obtained from a 5m walk in the gait laboratory. IMU data was collected using a commercial IMU (AMWS020, ATR-Promotions, Kyoto, Japan), which installs identical accelerometer and gyroscope with TSND151, at sampling rate of 200Hz. A single IMU was attached on each leg at the tibial tubercle of the subjects using a custom-made strapped band with pocket (Child corporation, Tokyo, Japan). The IMU data were recorded on a tablet using a commercial software (SensorController for Android, ATR-Promotions, Kyoto, Japan), and iKAM_impulse were calculated using the AI system generated in Gait study 1. To calculate the intraclass correlation coefficients (ICCs), all subjects repeated a 5m walk three times and the reliability of iKAM_impulse was evaluated.
Statistical analysis
In this study, our system was implemented using Scikit-learn, a Python module that integrates machine learning algorithms. [22,23] To evaluate the accuracy of a linear regression model, the mean absolute percent error (MAPE) and the mean absolute error (MAE) were used.
Intra-assessor probabilities were tested for one-way assignment agreement (ICC(1.1)(1.k)), and inter-assessor probabilities were tested for two-way assignment absolute agreement (ICC(2.1)(2.k)). Analyses were per-formed using IBM SPSS Statistics ver29.0.1.0.