Hallux Valgus DeformityNCT07036120
A Study on the Biomechanical Mechanisms of Orthotic/Physical Training Correction of Hallux Valgus and Its Impact on the Lower Limbs
A study testing orthosis and foot exercises in people with Hallux Valgus Deformity, run by Wan Xinzhu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hallux Valgus Deformity
- What is being tested?
- orthosis and foot exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hallux valgus angle > 15°
- Age 18-45 years
- Right leg dominant (based on the Waterloo Foot Questionnaire)
- Bilateral hallux valgus
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lei Qian contact
China1 site, 1 recruiting
- Recruiting
Southern Medical University
Guangzhou, Guangdong
Lei Qian, +8615626469836, dorisql712@126.com
About this study
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
- Being tested
- orthosis, foot exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthosisDevice
(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 exercisesBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| OR group | Experimental | 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. Receives: Device: orthosis |
| EX group | Experimental | 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. Receives: Behavioral: foot exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring muscle synergy using a 16-channel surface electromyography device
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.
Measured: From baseline to 12 weeks of intervention
Measuring kinematic synergy using optical infrared cameras
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.
Measured: From baseline to 12 weeks of intervention
Secondary outcomes (3)
Measuring hallux valgus angle with a protractor
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
Measured: 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
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.
Measured: From baseline to 12 weeks of intervention
Using a force plate to measure the center of foot pressure
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).
Measured: From baseline to 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start3 Jul 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux Valgus DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wan Xinzhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wan Xinzhu, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036120
- Sponsor's protocol ID
- NFYKX003
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39208038
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Biomechanical Mechanisms of Orthotic/Physical Training Correction of Hallux Valgus and Its Impact on the Lower Limbs
- ClinicalTrials.gov ID
- NCT07036120
- Acronym / sponsor ID
- NFYKX003
- Conditions
- Hallux Valgus Deformity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wan XinzhuUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OR group | Experimental | Device: orthosisThe 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. |
| EX group | Experimental | Behavioral: foot exercisesThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Hallux valgus angle > 15°
- Age 18-45 years
- Right leg dominant (based on the Waterloo Foot Questionnaire)
- Bilateral hallux valgus
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | OR group |
| foot exercises1. 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. | Behavioural | EX group |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 39208038Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Qian contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthosis and foot exercises in people with Hallux Valgus Deformity, run by Wan Xinzhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Qian (+8615626469836, dorisql712@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring muscle synergy using a 16-channel surface electromyography device (time frame: From baseline to 12 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07036120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.