Early Warning and Intervention Mechanism of Foot Health Risk in Children and Adolescents
Phase: NA
Conditions: Flexible Flatfoot
Sponsor: Nanfang Hospital, Southern Medical University

Clinical research protocol
Project Name:
Early warning and intervention mechanism of foot health risk in children
and adolescents
Scheme version number/date: V1.0/2024-04-22
Leader Unit/Main Researcher:
NA
Leader's Unit Address:
NA
Research Department/Principal Investigator: Department of Traditional Chinese Medicine
Orthopedics, Southern Hospital, Southern Medical University/Chen Chao
Applicant/Address: Southern Medical University Southern Hospital/1838 Guangzhou Avenue
North, Guangzhou City
Confidentiality Statement:
The information contained in this research protocol is only provided for review by the researchers, ethics
committee, and relevant institutions of this project. The copyright belongs to Southern Hospital of
Southern Medical University. Without the approval of Southern Hospital of Southern Medical University,
it is strictly prohibited to disclose any information to third parties unrelated to this study.

1
Summary of research proposal
Scheme Name
Early warning and intervention mechanism of foot health risk in children and
adolescents
Application
unit
Southern Medical University Southern Hospital
Main
researchers
Chen Chao
Team
leader
unit
N/A
Research
object
Children aged 6-18
research
objective
Main objective: To construct a foot health risk warning model based on
wearable sensors. Secondary objective: To explore the correlation
between children's foot health and musculoskeletal development
Research
Group
Observation group, WBV intervention group, martial arts intervention group
research
design
This clinical study is a prospective intervention study. Plan to recruit 1000
individuals aged 6-18.First, we collected gait data using sensors and
recorded the occurrence of foot pain for the next 4 weeks. Children with
foot pain will be enrolled in the observation group, exercise intervention
group, or WBV intervention group according to their wishes. After 4
weeks of intervention, analyze and compare the dynamic and static foot
movements
between
the
intervention
group
and
the
observation
group.Select 120 participants aged 8-10 for foot development in the second
stage.Observational study on the correlation with bone age development. In the
third stage, 30 participants aged 8-10 years were selected for an observational
study of gait dynamics using optical motion capture.
Research
period
From January 1, 2024 to December 31, 2027
sample size
1000
Inclusion
Criteria
Agree to participate in the study, and the legal representative voluntarily signs
the informed consent form
Children and adolescents aged 6-18 with typical development, regardless of
gender

2
Exclusion
criteria
Except for flat feet, there are other congenital deformities of the lower
limbs or spine that affect foot posture. In addition to flat feet, there are
other muscle, nerve, and bone diseases that affect foot posture. The
researchers have determined that they are not suitable to participate in
this study
Effectiveness
analysis
Main efficacy indicators: Motional foot posture improvement (push
off phase foot flip angle)
Secondary efficacy indicators: Static foot posture improvement (foot
posture index FPI-6)
Security
analysis
The detection equipment and methods used in this study mainly
include harmless optical motion capture, structured light 3D
scanning, wearable sensors, and bioelectrical resistance body
composition analysis;
X-ray, bone age, ultrasound and other imaging tests are all operated by
professional technicians, and the collection environment and methods meet
safety requirements; The intervention method is non pharmacological therapy,
which is harmless to the human body; The data acquisition and analysis process
strictly follows privacy protection regulations,and there is no security risks.
statistical
analysis
Analysis set: Use the full analysis set for statistical analysis. Full analysis
set (FAS): Includes all enrolled subjects who have received at least one non
pharmacological intervention and have measurable baseline foot injury.
Sample size determination: According to epidemiological surveys, the incidence
of foot pain events in children is about 12%, and it is determined based on
similar studies.
Statistical analysis: SPSS 25.0 statistical analysis software will be
used for statistical analysis
follow-up
Feedback on foot pain events;
Execution of martial arts training and vertical rhythm training;
The efficacy and adverse reactions of martial arts training and vertical rhythm
training.
Statistical
methods
The method used is independent sample t-test to analyze gait parameters of
normal and poor foot postures, and repeated measures ANOVA to analyze gait
and foot posture parameters before and after intervention.
Expected
progress
Starting from January 2024 to December 2024, recruit phase one participants
and initiate the study
Screening of Phase II subjects and conducting experiments from January 2025
to December 2025

3
Screening of Phase III subjects and conducting experiments from January 2026
to December 2027

4
List of abbreviations and definitions of terms
abbreviation
definition
WBV
Whole Body Vibration Training: The subject is placed on a
vibration platform that provides vertical sinusoidal vibrations to
the body, stimulating receptors and causing neuromuscular
excitation.
IMU
Inertial
Measurement
Unit:
including
gyroscope
and
accelerometer.

5
Experimental Procedure Table
project
baseline
Phase I
Phase II
Phase III
Asymptomatic
Foot pain
intervention
informed consent
√
√
√
√
√
Inclusion/exclusion
criteria
√
√
√
√
√
physical examination
√
√
√
√
√
Foot pain VAS score
√
√
√
All-weather sensors
√
√
WBV Training
√
TCM training
√
3D foot scan
√
√
√
√
Foot X-ray in weight-
bearing position
√
Analysis of Traditional
Chinese Medicine
Tongue Images
√
Body fat measurement
√
Saliva gene analysis
√
Wrist bone age
√
Bone density ultrasound
√
Magnetic resonance
imaging scan
√
Gait optical action
capture
√
Surface
electromyography
collection
√
Foot pressure test
√

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1.
Research background
1.1 research meaning
Foot injury is one of the most common motor system diseases in children, and the most common
clinical manifestation is foot pain. At present, there are few reports on the incidence of foot pain in
Chinese children. Foreign studies have shown that the incidence of foot pain in children and adolescents is
as high as 10% -15%, accompanied by the risk of foot injury and foot deformity. Our preliminary research
found the same pattern, with the highest proportion of foot pain among children aged 6-11 in Foshan
reaching 12.67%, and the proportion of foot pain gradually increases with age. Among young people who
frequently suffer from ankle sprains, about 25% have long-term ankle instability, making ankle injuries a
common disease among adolescents and children.
In recent years, the implementation of the "double reduction" policy has encouraged children to
increase their physical activity, with the aim of enhancing their physical fitness. However, due to
inadequate prevention and control measures, there have been more cases of ankle injuries in children in
clinical practice. There are 250 million children in China, and the estimated total number of foot injuries is
20-30 million. As age increases, the risk of foot injury and its complications increases, with approximately
24% of adults having experienced foot injury or foot disease [3,4]. The underdevelopment of children's
feet, abnormal foot shape, and uneven lower limb force lines are important structural causes of foot
injuries in children. As a result, abnormal foot movement posture is the dynamic cause of foot injuries.
Failure to correct abnormal foot movement posture in a timely manner after causing foot injury will
further lead to multi joint posture abnormalities, causing a vicious cycle of secondary injury, ultimately
affecting limb and trunk force lines, and causing damage to knee joints, hip joints, and spine [5,6]. Partial
injuries can cause serious consequences, such as cartilage damage to the talus, and may even lead to talus
necrosis, endangering children's health [7]. Early detection and intervention of foot injuries in children are
important tasks to ensure their healthy development.
Due to children's weak ability to express illnesses, foot pain is often concealed, making it difficult for
parents to detect potential foot diseases in their children. The symptoms of childhood foot disease are
different from those of adults, and the clinical manifestations are more diverse, including walking on
tiptoes, unwillingness to walk, limping, and inability to keep up with peers [8-10]. Therefore, it is
particularly crucial to monitor objective indicators related to children's foot injuries and rehabilitation
through certain methods, rather than relying on children's expressions or waiting for visual signs to appear
[11]. In clinical practice, the detection of foot movement posture can analyze the causes and risks of foot
injuries, and is also an important method for judging the effectiveness of rehabilitation interventions.
Commonly used systems include high-speed plantar pressure systems, optical motion capture systems, etc.
The principle is to obtain detailed posture characteristics of the foot during movement for analysis. When
movements exceeding physiological limits are detected, it can confirm the source of clinical injuries and
monitor the process of injury recovery [12-14].
However, the drawbacks of these methods are complex operation, high cost, and the ability to
perform very low frequency breakpoint detection. They are often used for simple observation of clinical
diagnosis and treatment processes after foot injuries have occurred, and cannot actually predict and

7
prevent the occurrence of injuries in advance. It is even more difficult to control the risk of foot injuries
and rehabilitation processes in large-scale children. Therefore, we used Huawei HUAWEI S-TAG inertial
sensors to observe the foot posture characteristics of children with foot injuries in the early stage. In the
study, it was found that the static and dynamic foot posture of children are closely related to foot pain,
mainly due to the significant difference in the angle of calcaneus valgus and the swing angle of the
longitudinal axis of the foot during gait (toe push off phase) between normal children and children with
foot pain. Based on the above, this project focuses on the research of neural network models for key
rehabilitation nodes in the core content of foot injury risk prediction, WBV intervention process, and
exercise intervention process. Inertial sensors are used to observe foot posture data 24/7, and regular
features in gait before injury and during rehabilitation process are mined. Neural network algorithms are
used to construct algorithm models, and recognition and evaluation models are established for earlier
"compensated", "decompensated", and "key rehabilitation node" gaits before injury. Prompt for
decompensated gait before injury occurs, thereby achieving early warning and monitoring of the
rehabilitation process before injury occurs. The prediction accuracy of this model approaches the real
world infinitely as the amount of training data continues to increase.
The development of arch morphology from physiologically flexible flat feet in children is a necessary
process for growth and development. The "Ling Shu" records: "The kidneys originate from gushing
springs, and the gushing springs are also in the heart of the feet." Traditional Chinese medicine believes
that "kidney qi begins at the foot of the foot," and the filling of kidney qi has an important impact on the
growth and development of children. Delayed growth and development in children and insufficient kidney
qi in adults are often treated with Yongquan acupoint or foot massage. The development time of the arch
of the foot is consistent with the theory in "Su Wen" about kidney qi, which states that "when a woman is
seven years old, her kidney qi is abundant and her teeth are longer; when a husband is eight years old, his
kidney qi is solid and his teeth are longer." Boys usually develop their arch of the foot about a year later
than girls. Around the age of 7, children's foot structures develop fully and their gait approaches that of
adults, with over half of them developing arch shapes; 7-12 years old is an important stage for children's
arch development, during which most children will gradually develop arch shape. Our team completed a
foot health screening project for 10000 children in Sanshui District, Foshan City in 2022, and found that
about 20% of children were still left with flat feet at the age of 12, which can be considered as "delayed
arch development". Domestic and foreign studies have shown that arch development is a part of the
human body's maturation process. Children with delayed arch development have a shorter average height,
higher obesity rates, and weaker physical abilities. By detecting the development of children's arch
morphology, it is expected to bring new research ideas and diagnosis and treatment plans for promoting
height in children and preventing obesity in adolescents. Therefore, exploring the relationship between
delayed arch development and abnormal growth and development is in line with the requirements of
"Healthy China 2030" and reflects the concept of "great health" and the important research content of the
concepts of "health" and "prevention of illness". Another objective of this study is to observe the
relationship between arch development and growth development in children.

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1.2 Current research status at home and abroad
Epidemiological progress of flat feet in children
The normal development of the foot during childhood, especially the development of the arch, is
extremely important for the activity and function of the adult foot [15]. The foot undergoes different
changes in morphological structure and function during childhood. Among them, the development of the
arch follows certain morphological rules at different ages: within a few weeks after birth, the arch is filled
with thick fat pads and disappears; Subsequently, as gross motor development progresses, the function of
the feet gradually becomes apparent; The transition stage from 3 to 4 years old is usually characterized by
flexible flat feet, during which the arch of the foot begins to develop. However, due to the insufficient
strength of various tissues such as foot muscles, tendons, and ligaments to meet the pressure caused by
children's functional activities, it is easy to cause arch deformation, which is an inevitable transition stage
in the growth and development process of some children's bodies. The age of 6 is a critical period for the
development of the arch of the foot [16], during which ossification is incomplete and plasticity is strong,
making it an important stage for the formation of stable joints and strong arches. At the age of 13-14,
children's arches stop developing due to the maturation of their bones during puberty.
Abnormal arch development can lead to flat feet and other deformities in children [17], posing a
threat to their health. Some patients may persist into adolescence and adulthood. Foreign studies have
shown that flat feet are a common foot deformity in children, mainly characterized by the collapse or
flattening of the medial longitudinal arch (MLA) of the foot, usually accompanied by abduction of the
forefoot, inversion of the midfoot, eversion of the hindfoot, abduction of the tarsal joint, and eversion of
the subtalar joint. Due to factors such as urbanization, premature/inappropriate shoe wearing,
overweight/obesity, excessive/insufficient exercise, and excessive joint laxity, the risk of developing flat
feet increases [18,19]. According to the impact of age on flatfoot in foreign children, it is estimated that
approximately 45% of preschool children and 15% of older children (with an average age of 10 years)
suffer from flatfoot [20]. There are significant differences in the estimated prevalence of flatfoot among
foreign epidemiology, ranging from 0.6-77.9% [20]. Although there are different estimates of the
prevalence of flatfoot in children.There is a consensus that the incidence of flatfoot disease is inversely
proportional to the age of children. The overall incidence of flat feet among 3226 children aged 7-12 in
Shanghai, China is 56.1%, and the incidence gradually decreases with age [21]. The detection rate of flat
feet is still 13% even at the age of 12. Lin et al. used a gait analysis system to study 377 children aged 2-6
years. The detection rates of moderate flat feet were 43%, 31%, 24%, and 19%, respectively; The
detection rates of severe flat feet are 14%, 9%, 4%, and 2%, respectively.

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The hazards of poor foot posture and foot pain
When children stand with flat feet, there is no good support at the bottom of the foot, resulting in the
inner edge being close to the ground and unable to provide cushioning, which can easily lead to fatigue
and foot pain. Long term development can have adverse effects on the joints and muscles of the foot,
which may lead to foot injury/foot disease. Abnormal foot movement posture can cause further multi joint
posture abnormalities after causing foot injury, leading to a vicious cycle of secondary injury and
ultimately affecting limb and trunk lines of force,causing damage to the knee joint, hip joint, and spine
[23,24]. Partial injuries can cause serious consequences, such as cartilage damage to the talus, and may
even lead to talus necrosis, endangering children's health [25].
Research shows that 1/4 of children have experienced pain in their skeletal muscle system, with over
1% of children seeking medical help each year due to musculoskeletal issues in their feet. Foot pain is the
most common musculoskeletal problem in the age group of 10-13 years old [26, 27]. In current research,
foot pain in children is often overlooked because it is believed to be less common than foot pain in adults.
However, the definition of pediatric foot pain may be broader than that of adult foot pain. In most cases,
pain is not often reported as the chief complaint of foot symptoms in children. On the contrary, parents
may notice their children limping, walking on their toes, preferring to be held instead of walking, unable to
keep up with their peers, or frequently complaining of muscle fatigue in their feet. In clinical clinics, 30%
of children and adolescents seek treatment for pain related conditions [28,29].

10
Intervention methods for children with flat feet
Most flexible flat feet do not require formal treatment, preventive treatment is sufficient, including
appropriate exercise, a balanced diet, and suitable shoes. Patients with mild flat feet and mild pain are
recommended to undergo conservative treatment, including orthopedic arch foot pads, orthopedic
shoes, foot orthotics, and ankle function training. If conservative treatment is ineffective, surgical
options should be considered, including joint reconstruction, joint fusion, and joint immobilization.
Generally, combined surgical treatment should be performed after fully understanding the cause.
In non-surgical treatment, orthopedic insoles/shoes/foot orthotics are the most commonly used
means, which integrate the morphological development laws of children's feet, arch development
mechanisms, bone growth characteristics, foot shape characteristics, and gait characteristics. The
design principles include adjusting the force points on the sole of the foot and dispersing foot
pressure; Support the arch of the foot and improve cushioning ability; Improve lower limb line of
force, provide stability and support; Improving proprioceptive experience and enhancing foot
comfort, among other aspects; Flat feet in children can have effective preventive and rehabilitation
functions [30]. However, studies have shown that orthopedic insoles/shoes or foot orthotics have
limited effectiveness in improving children's flexible flat feet [20]. In practical applications, children
have poor compliance due to discomfort in wearing/dressing, and due to rapid growth, they have to
replace frequently, which limits long-term portable applications due to high prices.
Secondly, children with flat feet usually undergo ankle function training such as plantar muscle
strength training, proprioceptive training, and balance training. However, traditional rehabilitation
training is usually conducted in hospital rehabilitation departments, with high requirements for
movements and postures, dry and repetitive training, poor child compliance, poor tracking of
training effects outside of hospitals, and inability to quantify training, which also limits its
application in home rehabilitation scenarios.
Research progress on whole-body vibration training
Whole Body Vibration Training (WBVT) transmits mechanical vibration stimulation through a
vibration platform to induce neuromuscular excitation, and has been validated by numerous studies to
enhance lower limb muscle strength, increase bone density, and improve functional activity in different
age groups [31]. Compared with traditional clinical methods, it has the advantages of high compliance,
quantifiability, good interactive experience, low cost, and rich application scenarios. In the future,
scalable virtual reality interaction will have both practical and entertaining effects, making it an excellent
choice for children's rehabilitation training. At present, most studies on WBV generally focus on the
overall posture of the whole body [32,33,34], and training the feet in different postures is rare [35]. In
addition to the influence of body position, different vibration parameters including vibration frequency,
amplitude, vibration mode, etc. can also affect the acceleration transfer and muscle activation effect of
WBV [36] [32,34,37]. However, currently there is still a lack of recommended optimal training schemes,
especially quantitative WBV training schemes for the feet. Swing board training can assist in the re
education of the sensory motor system by improving proprioceptor function and restoring normal

11
neuromuscular feedback circuits. It is commonly used for proprioceptive and balance training in patients
with ankle sprains, functional ankle instability, and other conditions. In 2012, Kiers et al. [39] proposed
that training only on unstable surfaces is not sufficient to stimulate ankle proprioceptors. He emphasized
that muscle bundles are highly sensitive to vibration stimuli, and muscle bundles are key to ankle
proprioceptive and overall body orientation. Marin and Hazell [40] demonstrated that the combination of
unstable surfaces and WBV can increase the electromyographic activity of lower limb and trunk muscles
to maintain balance. Similarly, patients with knee osteoarthritis also showed improvement in
proprioception after WBV training on a balance board. Rendo [41], Cloak [42], and others studied the
positive effects of this combined training on balance function and postural stability in patients with CAI.
Ray et al. found that WBV can improve posture stability when the environment is more challenging.
When the parameters of the platform are more challenging, it has a lasting impact on balance, lasting for
20 minutes. However, in less challenging environments, this effect disappears faster, 10-20 minutes.
These research results indicate that vibration can be studied as an auxiliary tool to provide more effective
balance function training for children with flat feet. Previous studies have lacked observation on the
therapeutic effect of WBV on flat feet in children, so it is necessary to conduct relevant research.
Progress in the study of martial arts
The Yi Jin Jing originated from ancient guidance techniques and is one of the important
traditional Chinese rehabilitation techniques. In clinical practice, Yi Jin is often used to treat bone
and joint diseases. By adjusting muscles and treating bones, it achieves a balance between the body's
muscles and bones, effectively improving the functions of the cardiovascular, respiratory, exercise,
endocrine, and immune systems [44,45]. Research has shown that elderly patients with skeletal
muscle atrophy can significantly improve their balance and walking stability after continuous
exercise of the Yi Jin Jing, effectively preventing falls and post fall injuries [46]. In addition, when
treating primary fibromyalgia syndrome, Yijin Jing can significantly alleviate pain symptoms [47].
According to the perspective of modern rehabilitation studies, the Yi Jin Jing not only provides
comprehensive training, but also Includes strength training for the feet. Therefore, the Yi Jin Jing is
one of the methods for treating children's foot pain, preventing the risk of joint injuries, enhancing
children's physical fitness, and improving muscle strength. It should be promoted and encouraged
for children to train. However, currently there is still a lack of quantitative indicators for the
therapeutic efficacy and mechanism of Yijin Jing in treating foot pain and foot diseases. Therefore,
combining wearable inertial sensors to evaluate the risk of foot pain and injury can provide a true
and objective quantitative evaluation of the effectiveness of the Yi Jin Jing in improving children's
foot symptoms and function, which can provide important data basis for future research and
promotion of the Yi Jin Jing. Research has shown that Yijin Jing can improve sub-health neck
fatigue in primary and secondary school students, and help prevent the occurrence of spinal
diseases in middle school students [48, 49]. At present, there is no research on the effectiveness of
traditional Chinese medicine techniques in treating flat feet in children, so it is necessary to conduct
research in this area.

12
2.
research objective
2.1 Main purpose
Constructing a foot health risk warning model based on wearable sensors
2.2 Secondary purpose
Exploring the correlation between children's foot health and musculoskeletal development;
3.
Study endpoint:
3.1 Primary endpoint indicator
If a wearable sensor gait detection is completed for 4 weeks and a foot pain event is reported, gait
data collection can be stopped.
3.2 Secondary endpoint indicators
After the occurrence of foot pain events, a 4-week observation or intervention was conducted under
the guidance of researchers, and the evaluation of the improvement of dynamic and static foot posture
was ultimately completed.
4.
experimental design
4.1 overall design
This clinical study is a prospective intervention study. We plan to recruit 1000 participants
aged 6-18,Over the next 4 weeks, sensors were used to collect gait data and record the occurrence
of foot pain. Children with foot pain will be enrolled in the observation group, exercise intervention
group, or WBV intervention group according to their wishes. After 4 weeks of intervention, analyze
and compare the differences in dynamic and static foot posture between the intervention group and
the observation group. In the second stage, 120 participants aged 8-10 were selected for an
observational study on the correlation between foot development and bone age development, and
all levels were completed on the day of the study. In the third stage, 30 participants aged 8-10 years
were selected for an observational study of gait dynamics using optical motion capture. Complete
all levels of the day.
4.2 Randomization and blinding
4.2.1 randomization
In the first stage of this study, it is expected that about 12% of the children will experience
foot pain, and eligible/ineligible patients will be enrolled according to their willingness to join the
observation group, WBV intervention group, or gongfa intervention group, with at least 34 cases in
each group, and no randomization will be conducted.
4.2.2 Blind state/Breaking blindness
This study will not be conducted in a blinded manner.

13
5.
Subject population
The subjects of this study are children and adolescents aged 6-18 years old.
5.1 Diagnostic criteria: Foot pain diagnosis is based on facial VAS score, foot posture evaluation is
based on foot posture index, foot 3D scanning and weight-bearing position foot X-ray, plantar soft
tissue development evaluation is based on plantar ultrasound, bone growth and development
evaluation is based on left wrist bone age, gene analysis uses saliva samples, traditional Chinese
medicine syndrome analysis uses the Four Diagnostic and Traditional Chinese Medicine Tongue
Image Intelligent Analysis System, gait and training motion dynamics analysis uses optical motion
capture combined with virtual simulation technology, etc.
5.2 Inclusion criteria:
1) Agree to participate in the study, and the legal representative voluntarily signs the informed
consent form
2) Children and adolescents aged 6-18 with typical development, regardless of gender
5.3 Exclusion criteria
1) Besides flat feet, there are other congenital deformities of the lower limbs or spine that affect
foot posture
2) History of muscle, nerve, and bone diseases that affect foot posture, except for flat feet
3) According to the researcher's judgment, it is not suitable to participate in this study
5.4 Exit criteria
All enrolled subjects have the right to withdraw from this study at any time.
Participants who withdraw from the study for any reason must record their reasons, including the
following:
1) The subject withdraws the informed consent form;
2) Subject lost to follow-up;
3) The legal representative of the subject refuses to continue the follow-up visit;
4) The researchers believe that for other reasons, the subjects are not suitable to continue
participating in this study;
Participants who withdraw from the study midway are considered dropout samples. When the
subject falls off, efforts should be made to obtain as much as possible contact, complete the
evaluation project, and fill out the research summary page.

14
5.5 Termination criteria
Termination criteria (terminated if any of the following criteria are met):
1) Serious safety issues occurred during the experiment;
2) Significant errors were found in the clinical trial protocol during the trial;
3) The ethics committee requests the termination of the experiment;
6.
Research instruments
1)
Height and weight measurement: using ultrasonic ranging and pressure sensors
2)
Body fat analysis: using bioelectrical impedance method to analyze the muscle fat ratio of
the human body
3)
Foot 3D scanner: using structured light, Class 2M, harmless to the human body and eyes
4)
S-TAG all-weather wearable sensor: using inertial measurement unit (IMU), including
gyroscope and accelerometer
5)
VICON optical motion capture system: (produced by Oxford Metrics Limited, UK),
sampling frequency 100Hz; Mainly including hardware and software facilities, the
hardware part includes 8 cameras, MX components, PC host, information conversion box,
calibration T-frame, reflective marker ball, and other accessories; The software part mainly
consists of VICON Nexus software.
6)
Vertical Rhythm Platform (WBV): Adjustable frequency, 3mm vertical synchronous
vibration
7)
Traditional Chinese Medicine Tongue Analysis System: An Image Recognition and
Analysis System Based on Artificial Intelligence
8)
Bone age DR system: using lead plates with micro radiation protection for movable wrist
measurement
9)
Bone density ultrasound: measurement with a fully dry (no temperature control device
required) oil bag probe, bidirectional ultrasound transmission and reception. No radiation,
suitable for testing various populations (children, pregnant women, adults, and elderly). It
is recommended to test within the age range of 3-100 years old (actual testing can be
conducted within 0-100 years old).
7.
Research methods and steps
As this is an experimental study, researchers will select the children to be included according to the
research protocol. Researchers will inquire about the medical history of the child's guardian and conduct
a physical examination of the child to determine their eligibility based on inclusion and exclusion

15
criteria. The guardian of the child must sign the latest IRB/IEC approved informed consent form (ICF)
before conducting data collection. The frequency and duration of visits shall be determined by the
doctor in accordance with the usual practice of the research plan.
7.1 Screening period:
All subjects are required to complete screening period related examinations before enrollment
and be screened according to inclusion and exclusion criteria.
1) Sign informed consent form
2) Record demographic data: date of birth, gender, initials;
3) Anthropometry: including height, weight, and length of both lower limbs
①
Measurement of length of both lower limbs
Measurement position: supine position, lower limbs extended, pelvis in neutral position, hip joint
in neutral position.
Measurement method: Use a soft tape to measure the shortest distance from the anterior superior
iliac spine to the medial malleolus, measure the left and right legs separately, and record the results in
the test registration form.
②
height
Measurement method: The subject stands barefoot in a "upright" position, with their heels,
sacrum, and shoulder blades tightly against the wall. The measurer can stand on either side of the
person being measured, adjust their head to the lowest point between the upper edge of the tragus and
the lower edge of the eye socket, and start the height measuring device to measure their height.
Measurement requirements: The height should be measured barefoot each time, using the same
measuring instrument at the same time (more accurately in the morning), with the same person
measuring as much as possible, and the body posture should be consistent before and after. Each
measurement of height requires two consecutive measurements with a 30 second interval. The results
of the two measurements should be roughly the same, and the error in height should not exceed 0.5
centimeters.
③
weight
Testing method: Wear lightweight clothing, stand barefoot, naturally on an electronic weight
scale, measure weight twice in a row with a 30 second interval. The results of the two measurements
should be roughly the same, and the error in weight should not exceed 0.5KG.

16
4) FacialVASscoreforfootpain
The subjects represent the degree of foot pain by selecting the corresponding pattern on the scale.
Figure 1 Facial VAS score for children: representing foot pain by selecting the corresponding pattern on the
scale degree
7.2 Phase One
We plan to recruit 1000 participants aged 6-18 to record their basic health status and static foot
posture at baseline.Subsequently, sensors were used to collect gait data for more than 8 hours per day for
the next 4 weeks, and all enrolled children wore wearable sensors in their daily lives. The obtained data
is uploaded to the cloud server through a mobile application, and remote monitoring and daily event
recording are achieved by uploading the data through the APP. When subjects experience foot pain
events, they should promptly report to the researchers through the APP. After determining foot pain
based on VAS scores, the subjects with foot pain will be enrolled in the observation group, exercise
intervention group, and WBV intervention group according to their wishes. Children in the observation
group should rest according to medical advice and not participate in sports activities. Children in the
intervention group received WBV vertical rhythm or exercise training programs under the guidance of
researchers' follow-up. The follow-up time is once a week, and the training lasts for a total of 4 weeks.
Using a self-developed app for researchers to remotely monitor and guide children's training movements,
and track training progress.

17
The device uses Huawei S-TAG foot rings, matched with HarmonyOS 2+/Android 6.0+/iOS
9.0+systems; IP68 (GB/T 4208-2017), waterproof rating of 50 meters; Bluetooth: BT 5.0 transmits data;
Running Scene
Battery life: Run for 1 hour per day, run 5 days a week, leave it still when not in use, and have a battery life of
30 days.
（1）WBV Vertical Rhythm Training Standard Process: Children enrolled in the study will
be trained at home using vertical rhythm equipment under the guidance of researchers and
parental supervision. WBV training lasts for 4 weeks, five days a week, with 15 minutes of
training per day. Each movement lasts for 30 seconds, and there is a 30 second break between
groups.
（2）Standard process for traditional Chinese medicine exercise training: Children enrolled in the group
will undergo exercise training under the supervision of their parents, following the teaching of a self-
developedAPP.TheYiJinJingtrainingwilllastfor4weeks,fivedaysa week,with15minutesoftraining
perday.Therewillbeatotalof12exercises,eachlasting1minute,witha 15secondbreakbetweengroups.
Figure 2 S-TAG Wearable Sensor
7.3 Phase 2
120 children aged 8-10 years were selected for an observational study on foot development and
growth development, without grouping, and no intervention procedures were performed in this stage of
the study. The following is the collected data:
Foot three-dimensional morphology: Using harmless and radiation free structured light three-
dimensional scanning to obtain foot three-dimensional morphology parameters. The subject stood
barefoot on a 3D foot scanner and tested their left and right feet separately.

18
Figure 3 Schematic diagram of 3D scanning of foot morphology
1)
Static foot posture: FPI-6 foot posture index, weight-bearing position foot X-ray
2)
Bone age analysis: using lead plates with micro radiation to protect the movable wrist and
measure bone age
3)
Bone density analysis: Measurement of bone density in the calcaneus using musculoskeletal
ultrasound
4)
Genomic grouping: Collecting saliva from children for whole genome analysis
5)
Body fat analysis: Evaluating body fat ratio using bioelectrical impedance method
6)
Traditional Chinese Medicine Constitution Evaluation: Using the Traditional Chinese
Medicine Body Mass Scale combined with tongue image analysis, "Classification and Identification
of Traditional Chinese Medicine Constitution in Children in Guangdong Province" (T/GDACM
0112-2022)
7.4 Phase Three
Select 30 children aged 8-10 for laboratory testing. This stage is an observational study without
grouping.
Passive optical motion capture system, using a floodlight sphere attached to various parts of the
human body as marker points, driven by motion capture the camera for spatial positioning and record the
motion trajectory. The ground reaction force of gait is obtained through the plantar pressure plate. The
surface muscle activation force is collected through a 16 channel Delsys surface electromyography testing
system: Noraxon bipolar disposable surface electromyography electrodes are used, with a distance of 20mm
between the electrodes. Used to collect the maximum voluntary contraction (MVC) of 4 hip and knee
muscles and 11 ankle muscles of the subjects, as well as the muscle strength change curves and maximum
force values during training, with a frequency set at 1000 Hz for model validation.
This technology is mature, with high accuracy, high sampling rate, and wireless, non luminous, non
heating, non radiative, and non-invasive detection. Motion capture systems have provided
comprehensive solutions for nearly a thousand users worldwide, widely used in fields such as motion
analysis and animation production.

19
Figure 4 Optical motion capture device
The collected actions are as follows:
1)
Gait analysis: Children walk 10 meters on the plantar pressure plate at their own pace and
collect dynamic parameters during the gait process.
2)
Analysis of martial arts movements: Children stand on a plantar pressure plate and collect
dynamic parameters of the training movements of the Yi Jin Jing.
Figure 5 Schematic diagram of optical motion capture in traditional Chinese medicine exercises
3)
Analysis of WBV Vertical Rhythm Training Actions: The subjects stand on a vertical
rhythm platform, adopt different heel lifting or squatting postures, maintain static posture for 30
seconds, and collect dynamic parameters during the period.
Figure 6 Schematic diagram of WBV rhythm training

20
Finite element analysis: Reconstruct muscle bone models from Dicom format files of children's
MRI scans, and use the muscle activation force obtained from motion capture parameters in virtual
simulation as boundary conditions for finite element analysis of structural stress in areas such as
the feet and waist.
Figure 7 Schematic diagram of finite element analysis
8.
evaluating indicator
The first stage is a prospective intervention study, in which children who experience foot pain
events are trained and intervened until the end of a 4-week intervention period, and the evaluation of
efficacy indicators is considered the endpoint of the rehabilitation study. The second and third stages
are observational studies, where participants' participation in laboratory testing on the same day is
considered the endpoint.
8.1 Main efficacy indicators
Dynamic Foot Posture: Gait Push Off Period Foot Outward Angle
Capture the angle of foot valgus during gait push off period through wearable devices, and compare the
difference between the values after intervention and before intervention.
Figure 8 Schematic diagram of wearable sensor dynamic foot axis

21
The red dashed line represents the longitudinal axis of the foot, and through wearable sensors, the angle
of this axis relative to the reference axis during the stance phase of gait can be calculated.
8.2 Secondary efficacy indicators
Static foot posture is evaluated using the Foot Posture Index FPI-6.
The FPI score should be an integer between -12 and 12, with 12 ≥FPI ≥8 indicating severe pronation
posture, 8>FPI ≥4 indicating mild pronation posture, -12 ≥FPI ≥-8 indicating severe supination
posture, -8>FPI ≥-4 indicating mild supination posture, and 4>FPI>-4 indicating neutral posture.
9.
Safety monitoring, reporting, and medical treatment
9.1 Definition of Adverse Events (AE)
Adverse events refer to any adverse medical events that occur after a patient or subject receives a
drug, which may not necessarily be causally related to the treatment. Therefore, adverse events can be any
adverse signs (including abnormal laboratory results), symptoms, or diseases that are temporally related to
the use of the study drug, regardless of whether a causal relationship with the study drug is considered.
Adverse events include Serious Adverse Events (SAEs) and Non Serious Adverse Events.
9.2 SAE Definition
SAE refers to medical events that occur during clinical trials that require hospitalization or
prolonged hospitalization, disability, affect work ability, endanger life or death, or cause congenital
malformations. Including the following medical events:
1）Events leading to death;
2）Life threatening events (defined as the risk of immediate death for the subject at the time of
the event);
3）Events that require hospitalization or prolonged hospitalization;
4）Events that can lead to permanent or severe disability/functional impairment/affect work
ability;
5）Congenital abnormalities or birth defects;
Other important medical events (defined as events that endanger the subjects or require
intervention to prevent any of the above situations from occurring).
9.3 Adverse event recording, collection, reporting, and handling
9.3.1 Definition of Adverse Events (AE):
AE is any adverse medical event that occurs in clinical research subjects and is time related to
the use of research treatment interventions, regardless of whether it is considered related to the

22
research treatment interventions. Therefore, AE can be any adverse and unexpected signs (including
abnormal laboratory results), symptoms, or signs that are time-dependent with the use of research
treatment interventions, condition or disease (new or aggravated).
Definition of Serious Adverse Event (SAE):
SAE refers to medical events that occur during clinical research that require hospitalization or
prolonged hospitalization, disability, affect work ability, endanger life or death, or cause congenital
malformations. Including the following medical events:
1) events leading to death;
2) Life threatening events (defined as the risk of immediate death for the subject at the time
of the event);
3) Events that require hospitalization or prolonged hospitalization;
4) Events that can lead to permanent or severe disability/functional impairment/affect work
ability;
5) Congenital abnormalities or birth defects;
Other important medical events (defined as events that endanger the subjects or require
intervention to prevent any of the above situations from occurring).
Definition of Suspected and Unexpected Serious Adverse Reaction (SUSAR):
Suspected and unexpected serious adverse reactions that exceed the nature and severity of the
clinical presentation beyond existing information such as the investigational drug investigator's manual,
marketed drug instructions, or product characteristic summaries
9.3.2 Collection, reporting, and processing of AE
All adverse events related to the operating procedures specified in the trial protocol that occur between
the signing of the informed consent form and the administration of the investigational drug must be recorded
in the APP database.
The record of AE should include: description of AE and all related symptoms, occurrence time,
severity, duration, relevance to the investigational drug, measures taken, and final results and
outcomes. The recording of AE must use medical terminology, and if the symptoms and signs of the
subjects can be summarized by a common cause, the diagnostic results should be recorded as much
as possible. Except for indicators related to disease progression, all clinical events and clinically
significant laboratory adverse reactions can be treated according to the Common Adverse Reaction
Event Evaluation Criteria (CTCAE) version 5.0. Adverse reactions caused by treatment will be
recorded by researchers.
9.3.3 Collection and reporting of SAE
All SAEs that occur within 4 weeks after the subjects sign the informed consent form and
complete the study, regardless of their cause or drug relevance, must be reported using the SAE

23
report form. If a serious adverse event (SAE) occurs, the researcher should immediately take
appropriate treatment measures for the subjects to ensure their safety. At the same time, the
researcher should report to the drug registration applicant, the National Medical Products
Administration, the Provincial Food and Drug Administration, the ethics committee of the
corresponding clinical trial center, and the Medical Department of the Health Commission and
Medical Administration Bureau within 24 hours, and promptly report to the ethics committee of the
leading unit. The first report should include the following information as much as possible: source of
the report, name of the investigational drug, name of serious adverse event, time of occurrence,
severity, duration, relevance to the investigational drug, measures taken, and outcome.
9.3.4 Criteria for determining the severity of AE
Researchers will evaluate the severity based on the five level judgment criteria developed by
NCI CTCAE 5.0:
Level 1, mild; Asymptomatic or with mild signs; For clinical or diagnostic observation only,
no medical intervention is required;
Level 2, moderate; Age appropriate daily life functions are restricted (such as cooking,
shopping, making phone calls, etc.);
Level 3, severe or medically significant but not immediately life-threatening; Causing
hospitalization or prolonging hospitalization time; a disability; Restricted daily self-care
activities (daily self-care activities refer to bathing, dressing, undressing, eating, toileting,
taking medication, etc., but not bedridden);
Level 4, life-threatening, requiring emergency treatment;
Level 5, AE related deaths;
9.3.5 Other responsibilities of researchers during follow-up of serious adverse events
Researchers should conduct corresponding examinations and treatments for serious adverse events
based on clinical judgment, including necessary clinical laboratory tests, physical examinations, etc. Any
inspection results or other updated SAE related information must be followed up with a follow-up report,
which has the same time limit and process as the initial report.
10. Test termination/suspension criteria
10.1 The applicant has the right to terminate/suspend this trial. Before terminating/suspending a
clinical trial, the applicant must notify the researchers, ethics committee, and the National Food and
Drug Administration, and state the reasons. After early termination/suspension of the study,
resuming the study must obtain approval from the ethics committee for review;
10.2 Termination/suspension requested by the ethics committee.
11. Regulations for ending clinical trials.
The experiment ends when all participants meet the following conditions:

24
1）All participants in the observational study completed all data collection, and all
participants in the continuous monitoring study completed data collection and reporting as
required after reaching the study endpoint.
2）Or all subjects may die, be lost to follow-up, or withdraw their informed consent.
12. data management
12.1 data management
1) Researchers must ensure that the data is true, complete, and accurate;
2) When making any corrections to the experimental records, only lines should be drawn and the
modified data should be annotated with reasons. The researcher should sign and indicate the date,
and the original records should not be erased or covered;
3) The laboratory inspection items are complete.
12.2. Data recording and file saving
The subject data on the case report form should be recorded in the form of subject codes, and
subjects can only be identified by their subject codes or their initials.
This experiment uses its own APP for data management: from data entry to source data
verification requirements, to questioning and answering quality control data, and finally to data
locking and export operations. After confirming that there are no doubts about the data, all parties
sign the database locking application form, and the data administrator locks the database. After the
database is locked, the data administrator exports the analysis database and submits it to the
statistical personnel for statistical analysis. The locked data cannot be edited again. Any issues
discovered after database locking can be corrected in the statistical analysis program after
confirmation.

25
13. statistical analysis
13.1 Sample size determination
This study is divided into three stages: the first stage is a prospective intervention study, and the
second and third stages are observational studies. The sample size of the experiment is mainly based on
the requirements of the first stage research, calculated using PASS 15.0 software. Compare the
differences in dynamic and static foot posture between the intervention group and the observation
group for subjects with foot pain after 4 weeks of intervention. Require bilateral testing, with α=0.05,
β=0.1, and a confidence (testing efficiency) of 1- β=90%. The expected difference in effect between the
intervention group and the observation group is 0.8, so each group requires 34 people, for a total of 102
people in the three groups. According to the preliminary epidemiological investigation, the incidence of
foot pain events in children is about 12%. The planned recruitment sample size is 1000 people, which
can collect about 120 cases of foot pain events, meeting the sample size requirements.
13.2 Definition and selection of analysis set
Use the full analysis set for statistical analysis. Full analysis set (FAS): Includes all enrolled
subjects who have received at least one non pharmacological intervention and have measurable
baseline foot injury.
13.3 statistical method
Independent sample t-test was used to compare gait parameters between children with foot pain
and those without symptoms, while repeated measures ANOVA was used to compare dynamic and
static foot posture parameters before and after training intervention.
13.4 Statistical software and general requirements:
All statistical analyses were conducted using SPSS 25.0 (or higher version).
Measurement data is described using mean, standard deviation, median, maximum, and
minimum values
Count data is described using frequency and percentage
14. Experimental management
14.1 Comply with GCP requirements
Management organization and implementation of GCP:
1) Researchers should adopt standard operating procedures to implement quality control
and quality assurance systems for clinical studies;
2) The original data must comply with relevant regulatory requirements;
3) The laboratory inspection results must be accurate and reliable;
4) All observations and findings used should be verified to ensure the reliability of the data;

26
5) Establish a complete research organization and clarify the responsibilities of personnel at
all levels;
6) The main researcher is responsible for comprehensive quality control and carries out the
responsibilities of personnel at all levels;
7) The main researcher is responsible for designing the research plan and informed consent
form, and after the research is completed, the main researcher writes the research summary
report;
8) Designated researchers are responsible for developing research implementation
guidelines and SOPs, which will be used in the study;
9) Prior to the study, the research team shall organize a learning program for all participants,
and all participants must undergo GCP training;
10)Physicians and nurses participating in the study must strictly comply with the protocol and
follow the procedures, and are not allowed to make arbitrary changes;
11)Designated statisticians are responsible for comprehensive statistical processing of data.
14.2 Protecting the privacy of participants
All data collected by participants during the study period will be stored and analyzed in a
confidential computer system. If necessary, relevant institutions may review the records to confirm
the authenticity, accuracy, and completeness of the data. The information obtained from the study
may also be published in academic journals, but the names of participants will not be disclosed and
their privacy will be kept confidential.
Take additional preventive measures to ensure the confidentiality of documents and prevent the
identification of subjects through genetic data. However, in special circumstances, some individuals
may be able to view a subject's facial data and personal identification code. For example, in the event of
a medical emergency, the sponsor, their representative physician, or researcher becomes aware of the
situation, subject identification code and access to the subject's facial data. In addition, relevant
regulatory agencies require access to relevant documents.
14.3 Problems that occurred during the experiment and their corresponding solutions
1)
Revision of the protocol: After approval by the ethics committee, if the protocol needs to
be revised, a "Protocol Revision Explanation" must be developed and signed by the principal
investigator. The revised plan can only be made after consultation and agreement between the
researcher and the drug registration applicant;
2)
After the revision of the plan, it needs to be reviewed and approved by the ethics
committee before it can be implemented;
3)
Any participant in the experiment shall not violate the protocol.

27
14.4 Quality Control and Quality Assurance
14.4.1 quality assurance
The sponsor or the collaborating unit entrusted by the sponsor to be responsible for all or part of
the responsibilities and tasks related to this study(including CRO, SMO, statistical units, clinical
centers, etc.) should establish their own quality assurance systems, fulfill their respective
responsibilities, strictly follow the clinical trial protocol, and adopt corresponding standard operating
procedures to ensure the implementation of clinical trial quality control and quality assurance
systems.
14.4.2 Quality assurance of clinical trial process
Before the initiation of clinical trials, researchers should receive training on the trial protocol to
enable them to have a full understanding and recognition of the specific connotations of the clinical
trial protocol and its various indicators. Quality control personnel should verify the basic conditions
of clinical trials to ensure that the clinical trial conditions meet the requirements of the protocol.
During the experimental process, researchers should conscientiously carry out clinical operations and
other work in accordance with the institutional SOP and experimental protocol requirements, and
record them truthfully, timely, completely, and standardly. Quality control personnel conduct quality
checks on the experimental process and corresponding original records. After the experiment is completed,
the research unit will organize the corresponding project documents, which will be checked by quality
control personnel and archived for preservation. The quality assurance department of the clinical research
unit conducts feasibility checks on the trials conducted. When non conformities are found, promptly notify
the researchers and unit leaders to make corrections, and track the progress of the corrections.
14.4 Expected progress and completion date of clinical trials

January 2024 to June 2024: Complete the recruitment of 1000 cases for the first phase of the
study

July 2024 to December 2025: Complete the second phase of research on 120 cases

From January 2026 to December 2027: Complete the third phase of research on 30 cases
14.5 Responsibilities of the applicant
The applicant is responsible for initiating, applying for, and organizing this clinical trial, and
providing trial funding.
The applicant selects the institution and researcherfor the clinical trial, recognizes their qualifications and
conditions to ensure the completion ofthe trial.
14.5.1 Responsibilities of Researchers
The clinical study will be conducted in accordance with the ethical, moral, and scientific
principles set forth in the Helsinki Declaration and the Chinese GCP regulations, as well as the
protocol design and regulations.

28
Researchers should be responsible for making medical decisions related to clinical trials and ensuring that
subjects receive timely treatment in case of adverse events during the trial period. Researchers should be
aware of the procedures and requirements for reporting SAEs, and record and report these events in
accordance with the requirements.
Researchers should accurately, completely, timely, and legally load data into eCRF, and accept
monitoring or inspection by supervisors or inspectors dispatched by the sponsor or CRO company,
as well as inspection and inspection by drug regulatory authorities, to ensure the quality of clinical
trials.
14.5.2 The method of publishing research data by the applicant
The applicant has exclusive rights to the data of this study. Unless obtaining written consent from
the sponsor, individual articles should not be published before the final report of the multicenter study
is completed. The applicant has the final decision-making power regarding the manuscript and
publication
14.5.3 The collection, sale, export, and exit of human genetic resources shall comply with the Interim
Measures for the Management of Human Genetic Resources (State Council Document No. 36 of 1998.
15. Ethics related to experiments
15.1 Ethics Committee
Before the start of the study, the researcher must submit the research protocol, informed consent
form, and any other information provided to the subjects to the ethics committee for approval. Any
revisions made to the experimental protocol must be approved by the ethics committee.
15.2 informed consent
Qualified researchers must provide each participant with a detailed explanation of the nature,
purpose, relevant procedures, expected time, potential risks and benefits, as well as any possible
discomfort of this trial in the informed consent. Each participant must be aware that participating in the
trial is voluntary, and they may withdraw from the trial and withdraw their informed consent at any time
without affecting their subsequent treatment or relationship with the treating physician.
The informed consent form should be provided in a standard writing format and preferably in non
professional language. Each informed consent form must include all relevant information mentioned
above and include a voluntary statement. The informed consent form needs to be submitted to the
ethics committee for approval.
After explaining the basic content of the experiment and ensuring that each participant understands the
purpose of the experiment, the researcher should require each participant to sign their name and date on the
informed consent form. Participants should read and consider their statements before signing and dated, and
should obtain an informed consent form for safekeeping after signing. Without obtaining informed consent
andsigningthe informed consentform, the subjects cannotenterthe trial.

29
15.3 other
When the subject is unable to independently participate in informed consent, a reliable and fair
witness/legal representative must be present throughout the entire process of informed consent. The
selection of fair witnesses/legal representatives shall not infringe upon the confidentiality rights of the
subjects. After the subject's verbal consent, the fair witness/legal representative should sign and date the
informed consent form to prove that the information is accurate.
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