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

NCT06581978 | Recruiting

• 1 other identifier: NFEC-2024-278
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Flexible Flatfoot

Keywords

Children; Flatfoot; Traditional Chinese medical exercises training; Wearable sensors; Whole body vibration

Outcome Measures

Primary Outcomes (2)

• Static foot posture

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

  Baseline , pre-intervention and immediately after the intervention

• Motional foot posture

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

  Baseline , pre-intervention and immediately after the intervention

Secondary Outcomes (2)

• Foot pain events

  Baseline , pre-intervention

• Bone maturity

  Baseline , pre-intervention

Study Arms (3)

Whole-Body Vibration Intervention Group

EXPERIMENTAL

Enrolled 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.

Procedure: Exercise Intervention Group

Control Group

NO INTERVENTION

Children were instructed to rest and not participate in physical activity

Traditional Chinese medical exercises training Intervention Group

EXPERIMENTAL

The 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.

Procedure: Whole-Body Vibration Intervention

Interventions

Whole-Body Vibration Intervention PROCEDURE

Whole-Body Vibration Intervention

Traditional Chinese medical exercises training Intervention Group

Exercise Intervention Group PROCEDURE

Traditional Chinese medical exercises training

Whole-Body Vibration Intervention Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Chao Chen, PhD

CONTACT

13580348819; pizzachan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

CN (1)