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

Wan Xinzhu

Status: Enrolling

Conditions: Hallux Valgus Deformity

Treatments: Behavioral: foot exercises; Device: orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT07036120

NFYKX003

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

OR group

Experimental group

Description:

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.

Treatment:

Device: orthosis

EX group

Experimental group

Description:

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.

Treatment:

Behavioral: foot exercises