Participants
There were 14 participants (12 men and two women, age 22 ± 1 years, height 1.70 ± 0.06 m, weight 65.07 ± 14.81 kg). The inclusion criteria were an absence of cognitive problems, motor sensory dysfunction in the lower extremities, and visual impairment. The study was explained verbally and in writing, and the participants provided written informed consent before participating in the study. This study was approved by the Research Ethics Committee of Kyoto Tachibana University (Approval No. 22-13) and conducted in accordance with the Declaration of Helsinki.
Protocol
Herein, each measurement device was first attached to the patient before any measurement was taken. All tasks were performed sitting on a chair with a backrest one step above the floor. The measurement tasks consisted of automatic voluntary movements of dorsiflexion, plantar flexion, inversion, and eversion of the foot on one side. They were performed in two ranges of motion, the maximum range of motion, and mild range of motion, according to the participant’s subjective judgement. For each automatic voluntary movement, two conditions were set according to the participant's subjective movement speed: "movement at a comfortable speed (comfortable speed condition)" and "movement at a slow speed (slow speed condition). These conditions were set to verify whether it is possible to measure a wide range of participants with mild to severe disabilities since the range of joint motion is assumed to be narrow and patients with motor dysfunction have slow movement. Each participant was required to complete five consecutives measurement tasks. The measurement task sequence was randomised using a random number table. The chair-sitting position with both hands on the knees was comfortable. Each measuring device was calibrated simultaneously in the midfoot position. The foot position was kept distal to the heel, away from the step, to maintain freedom of foot motion. Because biomechanical and neurophysiological studies have shown that foot motion is not lateralised [53,54], the kicking foot was determined to be the dominant foot in the measurement and was used as the measurement limb. Each participant’s dominant foot was the right foot. Measurements were taken using a video camera. The centre of the video camera lens was positioned at the centre of the foot; therefore, the height was adjusted using a tripod, and the camera was positioned 1 cm from the front and rear and 1 m from the right side (Fig. 2-a).
Instrumentation
On one of the participant’s legs, an AMAS, reflective marker, and IMU sensor was attached (Fig. 2-b).
1.AMAS
This system is a joint angle measurement device that simultaneously measures the plantarflexion/dorsiflexion and inversion/eversion angles during ankle joint motion and consists of an ankle joint orthosis, controller, and operation application (Fig. 3-a).
The Ankle Joint Unit (Fig. 3-b) consists of two units with a built-in rotary encoder (manufactured by Supertech Electronic). One unit was attached to the outer lower leg, which served as the basic axis, and the other was to the dorsal foot (metatarsal head), which served as the moving axis.
A pipe connects both units, and plantar dorsiflexion movement is transmitted to the basic axis-side unit via the connecting pipe, causing the rotary encoder to rotate. Similarly, the basic shaft-side unit supported the connecting pipe, and the inversion/eversion motion of the foot was transmitted to the rotary encoder of the mobile shaft-side unit. The controller transmits the signal from the rotary encoder resulting from foot joint motion to the application (tablet). The application converts the signals into angles and displays in real time the changes in plantarflexion/dorsiflexion and inversion/eversion angles over time. The angle data were saved as a CSV file.
The system simultaneously extracts the dorsiflexion/plantarflexion and inversion/eversion angles (degrees) of the foot. The sampling rate was 50 Hz.
2. 2DMA
The reference motion capture was performed using the free 2DMA software Image J (NIH, USA) for 2DMA with reflective markers. Nine anatomical landmarks were selected according to the methods of previous studies: the fibular head, tibial tuberosity, posterior medial surface of the lower leg, medial anterior surface of the medial and lateral phalanges, lateral malleolus, first and fifth metatarsal heads, posterior calcaneus (CAL), and directly above it [55]. Reflective markers were attached to the skin using double-sided tape at selected landmarks. Two 30 bps digital high-definition video cameras (Panasonic, Japan) were used to capture images from the anterior and posterior sides for the frontal plane task and the right lateral side for the sagittal plane task during the measurement task. The video captured by the video camera was clipped at 30 Hz using the free video playback software GOM Player (Gretech, Korea). Each data point was then extracted and corrected every 0.14 seconds. Capture data were used to calculate joint angles from 2D coordinates using the free 2D motion analysis software ImageJ. The dorsiflexion/plantarflexion angle of the foot in the sagittal plane is the angle between the straight line connecting the fibular head and the external capsule and the straight line connecting the fifth metatarsal head and the external capsule. The inversion/eversion angle of the foot viewed from the anterior is the angle between the lower leg axis consisting of the centre of the medial and lateral phalanges and the tibial coarse surface and the plantar axis consisting of the first and fifth metatarsal heads, based on the "Methods for Indication and Measurement of Range of Motion of Joints.” The angle of inversion/eversion of the foot viewed from the posterior is the angle between the line passing from the centre of the lower leg through the centre of the Achilles tendon and the line connecting the two markers at the rear of the heel.
From the 2DMA with sagittal plane videos, joint angles (degrees) were extracted with the dorsiflexion direction as positive and the plantar flexion direction as negative. From the 2DMA of the frontal plane video, the joint angles (degrees) were extracted, with the inversion direction as positive and the eversion direction as negative.
3.Inertial Measurement Unit(IMU)
Two MyoMotion sensors (Noraxon USA Inc., Scottsdale, AZ, USA) were used as inertial measurement units (IMU). The tibial sensor was wrapped around the lower leg using an attached belt, and the dorsal foot sensor was attached to double-sided tape. The sampling rate was 100 Hz.
From the IMU, dorsiflexion/plantarflexion and internal/external return angles (degrees) of the foot were extracted using sensors placed across the ankle joint.
Data analysis
The synchro light at the start of the IMU measurement and the sensor mat light input to the AMAS were used to synchronise the data. After the beginning of the video recording, the synchro light at the start of the IMU measurement was used to synchronise the video camera and IMU. The starting point of all the data was then temporally synchronised by the sensor mat signal input after the start of the AMAS measurement, and the sensor mat light was captured by the video camera. Synchronously measured data were corrected to align the data points. The data to be analysed were the time (s) taken for each measurement task extracted by each measurement device, the maximum angle (°) per frequency, and the angle (°) five consecutive times.
The statistical software SPSS (version 27.0; IBM Corporation, Armonk, NY, USA) was used for statistical analysis. Corresponding t-tests were used to test the difference in time between comfortable and slow conditions in the measurement task. All data were subjected to the Kolmogorov–Smirnov test of normality. The feature extraction of the AMAS was statistically validated for validity, the performance of the regression model, and repeatability and agreement of the measurement method [56]. For validity, the correlation coefficients between the AMAS and IMU were calculated from the results of the two-dimensional motion analysis. RMSE (1) was calculated as the performance index of the regression model [57].
$$RMSE=\sqrt{\frac{\sum {\left(X\left(t\right)-Y\left(t\right)\right)}^{2}}{n}}\text{⑴}$$
The maximum value of each of the five repeatedly extracted angular data was used in the analysis to evaluate repeatability. A two-way mixed model by a single examiner of the ICC was used [58]. Bland-Altman analysis was used to confirm the presence of systematic errors in the overall data to evaluate the agreement between the measurement methods and the characteristics of the measurement methods using the margin of error (LOA)(2)[59].
$$LOA=mean of difference \pm 1.96 x standard deviation of difference \left(2\right)$$
The significance level was set at 5%.