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NCT Number: NCT07036120

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

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.

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Key information

Conditions

Hallux Valgus Deformity

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

foot exercises

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

Primary outcomes

  1. Measuring muscle synergy using a 16-channel surface electromyography device

    Time frame: From baseline to 12 weeks of intervention

    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.

  2. Measuring kinematic synergy using optical infrared cameras

    Time frame: From baseline to 12 weeks of intervention

    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.

Secondary outcomes

  1. Measuring hallux valgus angle with a protractor

    Time frame: From baseline to 12 weeks of intervention

    The hallux valgus angle between the longitudinal axis of the 1st metatarsal and the longitudinal axis of the proximal phalanx of the 1st toe was measured using a protractor

  2. 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 SONIMAGE HS1 ultrasound diagnostic system to capture a cross-sectional image of the abductor hallucis, flexor hallucis brevis, and flexor digitorum brevis on the right side in a static position. Repeat image acquisition three times, measure the cross-sectional area using software, and take the maximum value.

  3. Using a force plate to measure the center of foot pressure

    Time frame: From baseline to 12 weeks of intervention

    Foot pressure center (COP) data collected during gait testing is standardized according to the physical characteristics of the test subject to generate COP total trajectory length (COP-D), medial and lateral COP deviation (COP-X), and anterior-posterior COP deviation (COP-Y).

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Qian

CONTACT

[email protected]

+8615626469836

Lei Qian

CONTACT

Sponsors and collaborators

Lead sponsor

Wan Xinzhu

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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