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

NCT06672796 | Not Yet Recruiting

• 1 other identifier: AnkaraYbu2024HV
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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

Hallux Valgus Deformity

Keywords

hallux valgus; toe spread out; physiotherapy; ultrasound; surface electromyography

Outcome Measures

Primary Outcomes (21)

• Hallux Valgus Angle

  A radiographic measurement (°) The angle created between the lines that longitudinally bisect the proximal phalanx and the first metatarsal.

  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

  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.

  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.

  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.

  Before treatment, after 6 months

• Length of the First Metatarsal

  A radiographic measurement Length of the first metarsal (centimeter)

  Before treatment, after 6 months

• Surface Electromyography

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

  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

  Before treatment, after 8 weeks, after 6 months

• Dorsoplantar Thickness

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

  Before treatment, after 8 weeks, after 6 months

• Mediolateral Width

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

  Before treatment, after 8 weeks, after 6 months

• Shear Wave Elastography

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

  Before treatment, after 8 weeks, after 6 months

• Plantar load

  Measurement with plantar pressure distrubiton analysis (kg/cm²)

  Before treatment, after 8 weeks, after 6 months

• Loads per unit of plantar segments

  Measurement with plantar pressure distrubiton analysis (kg/cm²)

  Before treatment, after 8 weeks, after 6 months

• Changes of loads during gait

  Measurement with plantar pressure distrubiton analysis (kg/cm²)

  Before treatment, after 8 weeks, after 6 months

• Gait-time graph

  Measurement with plantar pressure distrubiton analysis (%)

  Before treatment, after 8 weeks, after 6 months

• Maximum and average pressures

  Measurement with plantar pressure distrubiton analysis (kg/cm²)

  Before treatment, after 8 weeks, after 6 months

• Plantar Contact area

  Measurement with plantar pressure distrubiton analysis (cm²)

  Before treatment, after 8 weeks, after 6 months

• Plantar contact time

  Measurement with plantar pressure distrubiton analysis (msn)

  Before treatment, after 8 weeks, after 6 months

• Balance measurement

  Y-balance test

  Before first treatment, after 8 weeks, and after 6 months

• Physical performance tests

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

  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.

  Before first treatment, after 8 weeks, and after 6 months

Study Arms (3)

CG

ACTIVE COMPARATOR

8 weeks, stretching exercise

Other: Stretching exercise

SEG

ACTIVE COMPARATOR

8 weeks, stretching exercise and toe spread out standart protocol

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

Other: Resisted Toe Spread Out Exercise; Other: Stretching exercise

Interventions

Resisted Toe Spread Out Exercise OTHER

new resistance exercise phase in addition to the standard protocol

REG

Toe Spread Out Exercise OTHER

Standart protocol of toe spread out exercise

SEG

Stretching exercise OTHER

Toe stretching

CG; REG; SEG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahar Anaforoglu: lead

MeSH Terms

Conditions

Hallux Valgus

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Bahar Anaforoğlu Anaforoğlu, Associate Professor

CONTACT

+90 505 742 1220; anaforoglub@hotmail.com

Mahmut Beşli, Master of Physical Therapy

CONTACT

+90 542 556 8617; fzt.mahmutbesli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised controlled

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-10