AzTrials
AzTrials

Flexible FlatfootNCT06581978

Early Warning and Intervention Mechanism of Foot Health Risk in Children and Adolescents

A study testing Whole-Body Vibration Intervention and Exercise Intervention Group in people with Flexible Flatfoot, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This clinical study was a prospective intervention study. The growth and development parameters and kinematic parameters of 120 children were planned to be collected for an observational study, and then the sensors were used to collect long-term gait data for 4 weeks and record the occurrence of foot pain. Read more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Flexible Flatfoot
What is being tested?
Whole-Body Vibration Intervention and Exercise Intervention Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 Jan 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • They agreed to participate in the study, and their legal representatives voluntarily signed an informed consent form
  • 6-18 years old typical development of children and adolescents, gender not limited

Who cannot join

  • In addition to the flat feet, there are other effects foot posture or spinal congenital malformation of the lower limbs
  • At the investigator's discretion, he was not considered to be suitable to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Chao Chen, PhD, 13580348819 ext. 020-61648254, pizzachan@163.com

    Chao Chen, PhD

    Recruiting

Other trials in China

About this study

This clinical study was a prospective intervention study. The growth and development parameters and kinematic parameters of 120 children were planned to be collected for an observational study, and then the sensors were used to collect long-term gait data for 4 weeks and record the occurrence of foot pain. Children were assigned to the observation group, exercises intervention group, or WBV vertical rhythm intervention group according to their wishes. After 4 weeks of intervention, the dynamic and static foot posture differences between the intervention group and the observation group were analyzed and compared.

Read the detailed description

This clinical study plan to recruit 120 subjects aged 6-18 years to collect the following parameters:

  1. Three-dimensional shape of foot: The three-dimensional shape parameters of foot are obtained by 3D morphometric scanner, which is harmless to human body and has no radiation. The subjects stand barefoot on a 3D morphometric scanner and test their left and right feet respectively.
  2. Static foot posture: foot Posture Index-6, foot X-ray bearing position.
  3. Bone age analysis: Bone age is measured by using the stereotype protected mobile wrist with microradiation amount.
  4. Bone mineral density analysis: calcaneal bone mineral density is measured by musculoskeletal ultrasound.
  5. Genome grouping: Children's saliva is collected for whole genome analysis.
  6. Body fat analysis: Bioresistive method was used to evaluate body fat ratio.
  7. TCM physique assessment: Classification and Identification of TCM physique of Children in Guangdong Region by TCM Physique Scale combined with tongue image analysis (T/GDACM 0112 -- 2022).
  8. Passive optical motion capture system, plantar pressure system and surface EMG system are used to collect kinematic parameters.

A wearable sensor is used to collect gait data for more than 8 hours per day for 4 weeks, and all enrolled children wear the wearable sensor in their daily lives. The obtained data is uploaded to the cloud server through the mobile application, and the data is uploaded through the APP to achieve remote monitoring and daily event recording. When the subject has a foot pain event, it should be reported to the researchers through the APP in time. After determining the foot pain based on the VAS score, the foot pain subjects will be divided into the observation group, the exercise intervention group and the WBV vertical rhythm intervention group according to their willingness.

The children in the observation group followed the doctor's advice to rest and did not participate in sports activities. The children in the intervention group were followed up by the researchers to implement the WBV vertical rhythm or exercise training program. The follow-up time was once a week and the training lasted for 4 weeks. The self-developed APP was used for researchers to remotely monitor and guide children's training movements and track training progress. The device uses a Huawei S-TAG anklet that matches HarmonyOS 2+/Android 6.0+/iOS 9.0+. IP68 (GB/T 4208-2017), waterproof grade 50 meters; Bluetooth: BT 5.0 to transmit data; Running scenario battery life: running 1 hour a day, running 5 days a week, stationary placement when not in use, battery life of 30 days.

  1. WBV vertical rhythm training standard procedure: Enrolled children will be trained at home using vertical rhythm equipment under the guidance of researchers and parental supervision. WBV training lasted for four weeks, five days a week, 15 minutes a day, each movement lasted for 30 seconds, and 30 seconds of rest between groups.
  2. Standard process of TCM exercise training: The enrolled children will be supervised by their parents and follow the teaching of the self-developed APP for exercise training. The Yi Jin Jing training lasts for 4 weeks, 5 days a week, 15 minutes a day, 12 movements in total, each movement is 1 minute, and the rest between groups is 15 seconds. Improvement in static and dynamic foot posture is assessed at the end of the 4-week training period.
Being tested
Whole-Body Vibration Intervention, Exercise Intervention Group
Keywords
Children, Flatfoot, Traditional Chinese medical exercises training, Wearable sensors, Whole body vibration
Medical subject headings
Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole-Body Vibration InterventionProcedure or surgery

    Whole-Body Vibration Intervention

  • Exercise Intervention GroupProcedure or surgery

    Traditional Chinese medical exercises training

Study groups in NCT06581978
Study groupRoleWhat they receive
Whole-Body Vibration Intervention GroupExperimentalEnrolled children will be trained at home using a vertical rhythm device under the guidance of researchers and parental supervision. WBV training lasted for four weeks, five days a week, 15 minutes a day, each movement lasted for 30 seconds, and 30 seconds of rest between groups.
Receives: Procedure: Exercise Intervention Group
Control GroupNo interventionChildren were instructed to rest and not participate in physical activity
Traditional Chinese medical exercises training Intervention GroupExperimentalThe enrolled children will be supervised by their parents and follow the teaching of the self-developed APP for Yi Jin Jing exercises. The training lasts for 4 weeks, 5 days a week, 15 minutes a day, 12 movements in total, each movement is 1 minute, and the rest between groups is 15 seconds.
Receives: Procedure: Whole-Body Vibration Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Static foot posture

    Static foot posture is evaluated using 3D morphometric scanner, X-ray, and Foot Posture Index-6

    Measured: Baseline , pre-intervention and immediately after the intervention

  2. Motional foot posture

    Motional foot posture is evaluated using Passive optical motion capture, and wearable sensors

    Measured: Baseline , pre-intervention and immediately after the intervention

Secondary outcomes (2)
  1. Foot pain events

    Visual Analogue Scale (VAS) is used to evaluate foot pain, which asks patients to rate their pain level on a scale of 0 to 10 (0 = no pain; 10 = "worst pain ever"). On the VAS scale, patients draw a hash mark representing their pain level on an unmarked 10-cm line, with the left side marked as "no pain" and the right side marked as "unbearable pain".

    Measured: Baseline , pre-intervention

  2. Bone maturity

    Bone age taken by dual energy X ray bone age instrument, the equipment radiation is extremely low, the equivalent of flying two minutes, or about 20 minutes of walking in the sunshine, won't cause harm to human body. Bone mineral density (BMD) was measured by ultrasound bone densitometer, which can be used to measure the BMD of calcaneus in children without radiation and trauma.

    Measured: Baseline , pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06581978
Sponsor's protocol ID
NFEC-2024-278
Status last verified
Aug 2024
First submitted
25 Aug 2024
Last updated
3 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Whole-Body Vibration Intervention and Exercise Intervention Group in people with Flexible Flatfoot, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao Chen, PhD (13580348819 ext. 020-61648254, pizzachan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static foot posture (time frame: Baseline , pre-intervention and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in