Hallux Valgus DeformityNCT06672796
Comparison of the Effects of Different Exercise Protocols in Individuals with Hallux Valgus
A study testing Resisted Toe Spread Out Exercise, Toe Spread Out Exercise and Stretching exercise in people with Hallux Valgus Deformity, run by Bahar Anaforoglu.
Trial summary
The aim of this study was to determine the effects of 8 weeks of supervised in addition to stretching exercise resisted concentric and eccentric contraction protocol of toe spread out exercise on the angular severity of hallux valgus deformity, changes in the cross-sectional area, stiffness and thickness of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus Deformity
- What is being tested?
- Resisted Toe Spread Out Exercise, Toe Spread Out Exercise and Stretching exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65,
- Being diagnosed with mild or moderate HV according to the radiographic evaluation result,
- Having flexible HV,
- Being a volunteer
Who cannot join
- Having a neurological disease,
- Having a systemic disease,
- Having cognitive disorders such as dementia, Alzheimer's, etc.,
- Having spinal problems such as disc herniation, lumbar stenosis, scoliosis, etc.,
- Having claudication,
- Having idiopathic numbness, tingling, etc. complaints in the lower extremity,
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- Having had lower extremity surgery before,
- Having a fracture, ligament, or muscle injury in the lower extremity within the last 6 months,
- Having received foot-related treatment within the last 6 months.
- Not understanding the exercises,
- Not being able to continue with exercise sessions,
- Low homework exercise compliance,
- Foot structure not suitable for elastographic US examination,
- Incorrectly measured elasticity values in SWE,
- Not participating in the first or last evaluation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effects of Standard and Resisted Protocols of Toe Spread Out Exercise on Hallux Valgus Angle, Muscular Activation, Balance and Physical Performance in Individuals with Hallux Valgus.
The aim of this study was to determine the effects of 8 weeks of supervised in addition to stretching exercise resisted concentric and eccentric contraction protocol of toe spread out exercise on the angular severity of hallux valgus deformity, changes in the cross-sectional area, stiffness and thickness of the abductor hallucis muscle, electromyographic activities, plantar pressure distribution, foot morphology and gait characteristics, balance and physical performance at the end of the medium and long term.
- Conditions
- Hallux Valgus Deformity
- Being tested
- Resisted Toe Spread Out Exercise, Toe Spread Out Exercise, Stretching exercise
- Keywords
- hallux valgus, toe spread out, physiotherapy, ultrasound, surface electromyography
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resisted Toe Spread Out ExerciseOther
new resistance exercise phase in addition to the standard protocol
Toe Spread Out ExerciseOther
Standart protocol of toe spread out exercise
Stretching exerciseOther
Toe stretching
| Study group | Role | What they receive |
|---|---|---|
| CG | Active comparator | 8 weeks, stretching exercise Receives: Other: Stretching exercise |
| SEG | Active comparator | 8 weeks, stretching exercise and toe spread out standart protocol Receives: Other: Toe Spread Out Exercise; Other: Stretching exercise |
| REG | Experimental | 8 weeks, stretching exercise and resisted concentric and eccentric contraction protocol of toe spread out exercise Receives: Other: Resisted Toe Spread Out Exercise; Other: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux Valgus Angle
A radiographic measurement (°) The angle created between the lines that longitudinally bisect the proximal phalanx and the first metatarsal.
Measured: Before treatment, after 6 months
Intermetatarsal angle
A radiographic measurement (°) The term intermetatarsal angle alone typically refers to assessment of the first and second metatarsals
Measured: Before treatment, after 6 months
Hallux Interphalangeal Angle
A radiographic measurement (°) The hallux interphalangeal angle is between the proximal and distal phalanx of the great toe and serves for the evaluation of toe deformity at the level of the first interphalangeal joint.
Measured: Before treatment, after 6 months
Distal Metatarsal Articular Angle
A radiographic measurement (°) The distal metatarsal articular angle (DMAA) evaluates the relationship between the longitudinal axis and the articular surface of the first metatarsophalangeal joint and thus metatarsophalangeal coverage or joint congruity on a weight-bearing dorsoplantar radiograph of the foot.
Measured: Before treatment, after 6 months
Sesamoid Position Classification
A radiographic measurement (1-7 grades) The medial sesamoid position would be classified into 7 grades by the respective circle as the position of the medial sesamoid.
Measured: Before treatment, after 6 months
Length of the First Metatarsal
A radiographic measurement Length of the first metarsal (centimeter)
Measured: Before treatment, after 6 months
Surface Electromyography
Maximum volunteer isometric contarction (MVIC) of m. abductor hallucis
Measured: Before first treatment, after 8 weeks, and after 6 months
Cross Sectional Area
CSA of m. abductor hallucis with ultrasound (cm²) CSA: In muscle physiology, physiological cross-sectional area (PCSA) is the area of the cross section of a muscle perpendicular to its fibers, generally at its largest point
Measured: Before treatment, after 8 weeks, after 6 months
Dorsoplantar Thickness
Measurement muscle thickness (m. abductor hallucis) with ultrasound (cm)
Measured: Before treatment, after 8 weeks, after 6 months
Mediolateral Width
Measurement muslce width (m. abductor hallucis) with ultrasound (cm)
Measured: Before treatment, after 8 weeks, after 6 months
Shear Wave Elastography
Measurement SWE with ultrasound (m. abductor hallucis) (cm)
Measured: Before treatment, after 8 weeks, after 6 months
Plantar load
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Measured: Before treatment, after 8 weeks, after 6 months
Loads per unit of plantar segments
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Measured: Before treatment, after 8 weeks, after 6 months
Changes of loads during gait
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Measured: Before treatment, after 8 weeks, after 6 months
Gait-time graph
Measurement with plantar pressure distrubiton analysis (%)
Measured: Before treatment, after 8 weeks, after 6 months
Maximum and average pressures
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Measured: Before treatment, after 8 weeks, after 6 months
Plantar Contact area
Measurement with plantar pressure distrubiton analysis (cm²)
Measured: Before treatment, after 8 weeks, after 6 months
Plantar contact time
Measurement with plantar pressure distrubiton analysis (msn)
Measured: Before treatment, after 8 weeks, after 6 months
Balance measurement
Y-balance test
Measured: Before first treatment, after 8 weeks, and after 6 months
Physical performance tests
Gait speed (10 meter), Climbing stairs speed (10 meter)
Measured: Before first treatment, after 8 weeks, and after 6 months
Multidimensional Nil Hallux Valgus Scale
The scale has a score range of 0-60, with higher score indicating increased HV symptoms, complaints, and functional disorder.
Measured: Before first treatment, after 8 weeks, and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahar Anaforoglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahar Anaforoglu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672796
- Sponsor's protocol ID
- AnkaraYbu2024HV
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Standard and Resisted Protocols of Toe Spread Out Exercise on Hallux Valgus Angle, Muscular Activation, Balance and Physical Performance in Individuals with Hallux Valgus.
- ClinicalTrials.gov ID
- NCT06672796
- Acronym / sponsor ID
- AnkaraYbu2024HV
- Conditions
- Hallux Valgus Deformity
- Keywords
- hallux valgus, toe spread out, physiotherapy, ultrasound, surface electromyography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Bahar AnaforogluUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Nov 2024 (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 aim of this study was to determine the effects of 8 weeks of supervised in addition to stretching exercise resisted concentric and eccentric contraction protocol of toe spread out exercise on the angular severity of hallux valgus deformity, changes in the cross-sectional area, stiffness and thickness of the abductor hallucis muscle, electromyographic activities, plantar pressure distribution, foot morphology and gait characteristics, balance and physical performance at the end of the medium and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised controlled
| Arm | Type | Receives |
|---|---|---|
| CG | Active comparator | Other: Stretching exercise8 weeks, stretching exercise |
| SEG | Active comparator | Other: Toe Spread Out Exercise, Other: Stretching exercise8 weeks, stretching exercise and toe spread out standart protocol |
| REG | Experimental | Other: Resisted Toe Spread Out Exercise, Other: Stretching exercise8 weeks, stretching exercise and resisted concentric and eccentric contraction protocol of toe spread out exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65,
- Being diagnosed with mild or moderate HV according to the radiographic evaluation result,
- Having flexible HV,
- Being a volunteer
Key exclusion criteria (15 listed)
- Having a neurological disease,
- Having a systemic disease,
- Having cognitive disorders such as dementia, Alzheimer's, etc.,
- Having spinal problems such as disc herniation, lumbar stenosis, scoliosis, etc.,
- Having claudication,
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 |
|---|---|---|
| Resisted Toe Spread Out Exercisenew resistance exercise phase in addition to the standard protocol | Other | REG |
| Toe Spread Out ExerciseStandart protocol of toe spread out exercise | Other | SEG |
| Stretching exerciseToe stretching | Other | CG, REG, SEG |
Primary outcome
Hallux Valgus Angle
Time frame: Before treatment, after 6 months
A radiographic measurement (°) The angle created between the lines that longitudinally bisect the proximal phalanx and the first metatarsal.
Intermetatarsal angle
Time frame: Before treatment, after 6 months
A radiographic measurement (°) The term intermetatarsal angle alone typically refers to assessment of the first and second metatarsals
Hallux Interphalangeal Angle
Time frame: Before treatment, after 6 months
A radiographic measurement (°) The hallux interphalangeal angle is between the proximal and distal phalanx of the great toe and serves for the evaluation of toe deformity at the level of the first interphalangeal joint.
Distal Metatarsal Articular Angle
Time frame: Before treatment, after 6 months
A radiographic measurement (°) The distal metatarsal articular angle (DMAA) evaluates the relationship between the longitudinal axis and the articular surface of the first metatarsophalangeal joint and thus metatarsophalangeal coverage or joint congruity on a weight-bearing dorsoplantar radiograph of the foot.
Sesamoid Position Classification
Time frame: Before treatment, after 6 months
A radiographic measurement (1-7 grades) The medial sesamoid position would be classified into 7 grades by the respective circle as the position of the medial sesamoid.
Length of the First Metatarsal
Time frame: Before treatment, after 6 months
A radiographic measurement Length of the first metarsal (centimeter)
Surface Electromyography
Time frame: Before first treatment, after 8 weeks, and after 6 months
Maximum volunteer isometric contarction (MVIC) of m. abductor hallucis
Cross Sectional Area
Time frame: Before treatment, after 8 weeks, after 6 months
CSA of m. abductor hallucis with ultrasound (cm²) CSA: In muscle physiology, physiological cross-sectional area (PCSA) is the area of the cross section of a muscle perpendicular to its fibers, generally at its largest point
Dorsoplantar Thickness
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement muscle thickness (m. abductor hallucis) with ultrasound (cm)
Mediolateral Width
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement muslce width (m. abductor hallucis) with ultrasound (cm)
Shear Wave Elastography
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement SWE with ultrasound (m. abductor hallucis) (cm)
Plantar load
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Loads per unit of plantar segments
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Changes of loads during gait
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Gait-time graph
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement with plantar pressure distrubiton analysis (%)
Maximum and average pressures
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Plantar Contact area
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement with plantar pressure distrubiton analysis (cm²)
Plantar contact time
Time frame: Before treatment, after 8 weeks, after 6 months
Measurement with plantar pressure distrubiton analysis (msn)
Balance measurement
Time frame: Before first treatment, after 8 weeks, and after 6 months
Y-balance test
Physical performance tests
Time frame: Before first treatment, after 8 weeks, and after 6 months
Gait speed (10 meter), Climbing stairs speed (10 meter)
Multidimensional Nil Hallux Valgus Scale
Time frame: Before first treatment, after 8 weeks, and after 6 months
The scale has a score range of 0-60, with higher score indicating increased HV symptoms, complaints, and functional disorder.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Resisted Toe Spread Out Exercise, Toe Spread Out Exercise and Stretching exercise in people with Hallux Valgus Deformity, run by Bahar Anaforoglu.
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 15 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: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar Anaforoğlu Anaforoğlu, Associate Professor (+90 505 742 1220, anaforoglub@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallux Valgus Angle (time frame: Before treatment, after 6 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2024.