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NCT Number: NCT06672796

Comparison of the Effects of Different Exercise Protocols 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.

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Key information

Conditions

Hallux Valgus Deformity Foot Deformities Hallux Valgus Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Resisted Toe Spread Out Exercise

Other

new resistance exercise phase in addition to the standard protocol

Toe spread out exercise

Other

Standart protocol of toe spread out exercise

stretching exercise

Other

Toe stretching

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Length of the First Metatarsal

    Time frame: Before treatment, after 6 months

    A radiographic measurement Length of the first metarsal (centimeter)

  7. Surface Electromyography

    Time frame: Before first treatment, after 8 weeks, and after 6 months

    Maximum volunteer isometric contarction (MVIC) of m. abductor hallucis

  8. 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

  9. Dorsoplantar Thickness

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement muscle thickness (m. abductor hallucis) with ultrasound (cm)

  10. Mediolateral Width

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement muslce width (m. abductor hallucis) with ultrasound (cm)

  11. Shear Wave Elastography

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement SWE with ultrasound (m. abductor hallucis) (cm)

  12. Plantar load

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement with plantar pressure distrubiton analysis (kg/cm²)

  13. Loads per unit of plantar segments

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement with plantar pressure distrubiton analysis (kg/cm²)

  14. Changes of loads during gait

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement with plantar pressure distrubiton analysis (kg/cm²)

  15. Gait-time graph

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement with plantar pressure distrubiton analysis (%)

  16. Maximum and average pressures

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement with plantar pressure distrubiton analysis (kg/cm²)

  17. Plantar Contact area

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement with plantar pressure distrubiton analysis (cm²)

  18. Plantar contact time

    Time frame: Before treatment, after 8 weeks, after 6 months

    Measurement with plantar pressure distrubiton analysis (msn)

  19. Balance measurement

    Time frame: Before first treatment, after 8 weeks, and after 6 months

    Y-balance test

  20. Physical performance tests

    Time frame: Before first treatment, after 8 weeks, and after 6 months

    Gait speed (10 meter), Climbing stairs speed (10 meter)

  21. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bahar Anaforoğlu Anaforoğlu, Associate Professor

CONTACT

[email protected]

+90 505 742 1220

Mahmut Beşli, Master of Physical Therapy

CONTACT

[email protected]

+90 542 556 8617

Sponsors and collaborators

Lead sponsor

Bahar Anaforoglu

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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