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Recruiting NCT07036120

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

No phase Interventional Hallux Valgus Deformity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: orthosis, foot exercises.
Who it may be relevant to
Registry conditions: Hallux Valgus Deformity. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device orthosis
    (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 str
  • Behavioral foot exercises
    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.

Primary outcome measures

  • Measuring muscle synergy using a 16-channel surface electromyography device [Time frame: From baseline to 12 weeks of intervention]
  • Measuring kinematic synergy using optical infrared cameras [Time frame: From baseline to 12 weeks of intervention]
Secondary outcome measures (3)
  • Measuring hallux valgus angle with a protractor [Time frame: 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 [Time frame: From baseline to 12 weeks of intervention]
  • Using a force plate to measure the center of foot pressure [Time frame: From baseline to 12 weeks of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

China · 1 center
  • Southern Medical University — Guangzhou

Publications

  • 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

Identifiers

NCT: NCT07036120 · NFYKX003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗