A Study on the Biomechanical Mechanisms of Orthotic/Physical Training Correction of Hallux Valgus and Its Impact on the Lower Limbs

NCT07036120 | Recruiting

• 1 other identifier: NFYKX003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study population of this project is mainly young people. Our goal is to investigate the kinematic and kinetic characterization brought about by different conservative treatment modalities for hallux valgus. The main study involves recruiting volunteers, grouping them into 12-week interventions with orthotics or foot exercises, and analyzing the kinematic and kinetic alterations in young and middle-aged subjects before, during, and after cessation of the interventions by motion capture, surface electromyography, and musculoskeletal ultrasound. A database of human biomechanical characteristics was constructed through in-vivo exercise techniques to analyze changes in the biomechanical characteristics of the population with hallux valgus after the use of different intervention methods.

Conditions

Hallux Valgus Deformity

Outcome Measures

Primary Outcomes (2)

• Measuring muscle synergy using a 16-channel surface electromyography device

  The Pearson correlation coefficient (r) was used to measure the independence of individual modules and the consistency of synergistic effects among individuals in the same group. When r \> 0.7, it was considered that there was similarity between the two synergy modules. Muscles with a median value \> 0.3 in the spatial components of the module were considered to be activated muscles in that module.

  From baseline to 12 weeks of intervention

• Measuring kinematic synergy using optical infrared cameras

  The Pearson correlation coefficient (r) was used to measure the independence of individual modules and the consistency of synergistic effects among individuals in the same group. When r \> 0.7, it was considered that there was similarity between the two synergy modules. Degree of freedom (DoF) with a median value \> 0.25 in the spatial components of the module were considered to be activated DoF in that module.

  From baseline to 12 weeks of intervention

Secondary Outcomes (3)

• Measuring hallux valgus angle with a protractor

  From baseline to 12 weeks of intervention

• Using ultrasound diagnostic system to capture a cross-sectional image of the thickest part of the muscle for measuring the cross-sectional area of the muscle

  From baseline to 12 weeks of intervention

• Using a force plate to measure the center of foot pressure

  From baseline to 12 weeks of intervention

Study Arms (2)

OR group

EXPERIMENTAL

The orthotic group was asked to wear a prefabricated toe orthotic (FORTH, China) on both feet at night each day, which was uniformly procured through an online shopping route prior to the start of the intervention. Subjects were required to wear the orthotics for a minimum of 8 hours per day and were monitored by uploading photos daily. Before the start of the intervention, the patients were instructed on the use of the orthoses and were given a demonstration of wearing the orthoses.

Device: orthosis

EX group

EXPERIMENTAL

The exercise training group was asked to implement an exercise program for no less than days 5 days per week, and in addition to the fascia ball and elastic bands (LI-NING, China) required for training, subjects were also given a document containing a textual description of the exercise program and a prerecorded video of the actual exercise, which contained information about the exercise position, number of repetitions, duration of contraction, rest time between sets, frequency, and precautions. They were monitored by uploading daily exercise hours and photos, and problems affecting their compliance were addressed.

Behavioral: foot exercises

Interventions

orthosis DEVICE

(1) one pair of two orthoses, regardless of the right and left sides; (2) loosen the two Velcro straps, put the large Velcro strap into the arch of the foot, and put the small Velcro strap on the thumb; (3) place the rigid plastic fixation plate along the medial edge of the foot and align the axis of rotation with the 1st metatarsalphalangeal joint; (4) tighten the Velcro straps as much as possible to prevent dislocation of the orthoses, without interfering with sleep; (5) tighten the Velcro straps to prevent dislocation of the orthoses, and to prevent the orthoses from moving out of position. Tighten the Velcro straps as much as possible without disturbing sleep to prevent the orthosis from shifting and to position the phalanx correctly in the outer table. Contact the laboratory staff for a new pair of orthotics if the adhesive tape is not sufficiently sticky to maintain positional fixation during sleep.

OR group

foot exercises BEHAVIORAL

1. Warm-up: 30 seconds per movement 1. Joint loosening 2. Plantar relaxation 2. Toe spreading: 10 reps/set, 3 sets/day 3. Toe grasping towel: 10 times/set, 3 sets/day 4. Standing Heel Raise: 10 times/group, 3 groups/day 5. Short Foot Exercise: 10 times/sets, 3 sets/day 6. Relax the soles of the feet again at the end of all exercises.

EX group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hallux valgus angle \> 15°
• Age 18-45 years
• Right leg dominant (based on the Waterloo Foot Questionnaire)
• Bilateral hallux valgus

You may not qualify if:

• History of lower limb surgery or neuromuscular diseases causing gait abnormalities (such as lumbar disc herniation and chronic ankle instability)
• Any treatment for hallux valgus within the past 3 months

Sponsors & Collaborators

• Wan Xinzhu: lead

Study Sites (1)

Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

• Liu Y, Liu R, Wan X, Chen C, Wang Y, Yu W, OuYang J, Qian L, Liu G. The Effect of Short-Term Kinesiology Taping on Neuromuscular Controls in Hallux Valgus During Gait: A Study of Muscle and Kinematic Synergy. IEEE Trans Neural Syst Rehabil Eng. 2024;32:3199-3209. doi: 10.1109/TNSRE.2024.3451651. Epub 2024 Sep 5.

  PMID: 39208038 BACKGROUND

MeSH Terms

Interventions

Orthotic Devices

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Lei Qian

CONTACT

+8615626469836; dorisql712@126.com

Lei Qian

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Master's Candidate, Department of Basic Medical Sciences, Southern Medical University

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: July 3, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)