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

ConditionFlexible Flatfoot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Whole-Body Vibration Intervention

    Procedure/Surgery

    Whole-Body Vibration Intervention

  • Exercise Intervention Group

    Procedure/Surgery

    Traditional Chinese medical exercises training

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Whole-Body Vibration Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Group C: Traditional Chinese medical exercises training Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Static foot posture

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

Time frame
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

Time frame
Baseline , pre-intervention and immediately after the intervention

Secondary outcomes

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".

Time frame
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.

Time frame
Baseline , pre-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov
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