NCT07036120

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Wan Xinzhu · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 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.
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.

Timeline

• Start date: 2025-07-03
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-06-25
• Last updated: 2025-07-15

Locations

1 site across 1 country: China