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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07036120
Enrollment
20
Registered
2025-06-25
Start date
2025-07-03
Completion date
2025-12-31
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus Deformity

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.

Interventions

DEVICEorthosis

(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.

BEHAVIORALfoot 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.

Sponsors

Wan Xinzhu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measuring muscle synergy using a 16-channel surface electromyography deviceFrom baseline to 12 weeks of interventionThe 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.
Measuring kinematic synergy using optical infrared camerasFrom baseline to 12 weeks of interventionThe 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

MeasureTime frameDescription
Measuring hallux valgus angle with a protractorFrom baseline to 12 weeks of interventionThe 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
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 muscleFrom baseline to 12 weeks of interventionUsing 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.
Using a force plate to measure the center of foot pressureFrom baseline to 12 weeks of interventionFoot 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).

Countries

China

Contacts

Primary ContactLei Qian
dorisql712@126.com+8615626469836
Backup ContactLei Qian

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026