Not yet recruitingNCT06672796Updated Nov 4, 2024

Comparison of the Effects of Different Exercise Protocols in Individuals with Hallux Valgus

An interventional study of Resisted Toe Spread Out Exercise and Toe Spread Out Exercise in Hallux Valgus Deformity, sponsored by Bahar Anaforoglu. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-04.

Sponsored by Bahar Anaforoglu · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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 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 studied

Hallux Valgus Deformity

Browse trials for

Hallux Valgus 157

Keywords

hallux valgus
toe spread out
physiotherapy
ultrasound
surface electromyography

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 42 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

This is the only study on the registry with Bahar Anaforoglu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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,
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Investigator, Outcomes assessor)
Enrollment: 42 participants (estimated)

Study arms

Active comparator
CG
8 weeks, stretching exercise
Other: Stretching exercise
Active comparator
SEG
8 weeks, stretching exercise and toe spread out standart protocol
Other: Toe Spread Out Exercise · Other: Stretching exercise
Experimental
REG
8 weeks, stretching exercise and resisted concentric and eccentric contraction protocol of toe spread out exercise
Other: Resisted Toe Spread Out Exercise · Other: Stretching exercise

Interventions

OtherResisted Toe Spread Out Exercise
new resistance exercise phase in addition to the standard protocol
OtherToe Spread Out Exercise
Standart protocol of toe spread out exercise
OtherStretching exercise
Toe stretching

What researchers measure

Primary outcomes

Hallux Valgus Angle
A radiographic measurement (°) The angle created between the lines that longitudinally bisect the proximal phalanx and the first metatarsal.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before treatment, after 6 months
Length of the First Metatarsal
A radiographic measurement Length of the first metarsal (centimeter)
Time frame: Before treatment, after 6 months
Surface Electromyography
Maximum volunteer isometric contarction (MVIC) of m. abductor hallucis
Time frame: 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
Time frame: Before treatment, after 8 weeks, after 6 months
Dorsoplantar Thickness
Measurement muscle thickness (m. abductor hallucis) with ultrasound (cm)
Time frame: Before treatment, after 8 weeks, after 6 months
Mediolateral Width
Measurement muslce width (m. abductor hallucis) with ultrasound (cm)
Time frame: Before treatment, after 8 weeks, after 6 months
Shear Wave Elastography
Measurement SWE with ultrasound (m. abductor hallucis) (cm)
Time frame: Before treatment, after 8 weeks, after 6 months
Plantar load
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Time frame: Before treatment, after 8 weeks, after 6 months
Loads per unit of plantar segments
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Time frame: Before treatment, after 8 weeks, after 6 months
Changes of loads during gait
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Time frame: Before treatment, after 8 weeks, after 6 months
Gait-time graph
Measurement with plantar pressure distrubiton analysis (%)
Time frame: Before treatment, after 8 weeks, after 6 months
Maximum and average pressures
Measurement with plantar pressure distrubiton analysis (kg/cm²)
Time frame: Before treatment, after 8 weeks, after 6 months
Plantar Contact area
Measurement with plantar pressure distrubiton analysis (cm²)
Time frame: Before treatment, after 8 weeks, after 6 months
Plantar contact time
Measurement with plantar pressure distrubiton analysis (msn)
Time frame: Before treatment, after 8 weeks, after 6 months
Balance measurement
Y-balance test
Time frame: Before first treatment, after 8 weeks, and after 6 months
Physical performance tests
Gait speed (10 meter), Climbing stairs speed (10 meter)
Time frame: 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.
Time frame: Before first treatment, after 8 weeks, and after 6 months

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Dec 2025, 11 months later.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 11 months is below that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 30, 2024
First posted: Nov 4, 2024
StartEst.: Jan 1, 2025
Primary completionEst.: Dec 31, 2025
CompletionEst.: Jun 30, 2026
Last update: Nov 4, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06672796
Lead sponsor: Bahar Anaforoglu
Responsible party: Bahar Anaforoglu (Associate Professor, Ankara Yildirim Beyazıt University) — Sponsor-investigator
First posted: Nov 4, 2024
Start date: Jan 1, 2025 (estimated)
Primary completion: Dec 31, 2025 (estimated)
Completion: Jun 30, 2026 (estimated)
Last update: Nov 4, 2024

Study contacts

Bahar Anaforoğlu Anaforoğlu, Associate Professor

Contact

anaforoglub@hotmail.com

+90 505 742 1220

Mahmut Beşli, Master of Physical Therapy

Contact

fzt.mahmutbesli@gmail.com

+90 542 556 8617

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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