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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hallux Valgus Deformity
• Intervention / Treatment: Other: Stretching exercise; Other: Toe Spread Out Exercise; Other: Resisted Toe Spread Out Exercise

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bahar Anaforoğlu Anaforoğlu, Associate Professor; Phone Number: +90 505 742 1220; Email: anaforoglub@hotmail.com
• Study Contact Backup: Name: Mahmut Beşli, Master of Physical Therapy; Phone Number: +90 542 556 8617; Email: fzt.mahmutbesli@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CG; 8 weeks, stretching exercise	Other: Stretching exercise; Toe stretching
Active Comparator: SEG; 8 weeks, stretching exercise and toe spread out standart protocol	Other: Stretching exercise; Toe stretching; Other: Toe Spread Out Exercise; Standart protocol of toe spread out exercise
Experimental: REG; 8 weeks, stretching exercise and resisted concentric and eccentric contraction protocol of toe spread out exercise	Other: Stretching exercise; Toe stretching; Other: Resisted Toe Spread Out Exercise; new resistance exercise phase in addition to the standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bahar Anaforoglu

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; physiotherapy; hallux valgus; surface electromyography; toe spread out
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Bunion; Hallux Valgus
• Other Study ID Numbers: AnkaraYbu2024HV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No