Clinical trial NCT06672796: Comparison of the Effects of Different Exercise Protocols in Individuals with Hallux Valgus
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hallux Valgus Deformity
Keywords: hallux valgus
toe spread out
physiotherapy
ultrasound
surface electromyography
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hallux Valgus Angle
timeFrame: Before treatment, after 6 months
measure: Intermetatarsal angle
timeFrame: Before treatment, after 6 months
measure: Hallux Interphalangeal Angle
timeFrame: Before treatment, after 6 months
measure: Distal Metatarsal Articular Angle
timeFrame: Before treatment, after 6 months
measure: Sesamoid Position Classification
timeFrame: Before treatment, after 6 months
measure: Length of the First Metatarsal
timeFrame: Before treatment, after 6 months
measure: Surface Electromyography
timeFrame: Before first treatment, after 8 weeks, and after 6 months
measure: Cross Sectional Area
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Dorsoplantar Thickness
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Mediolateral Width
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Shear Wave Elastography
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Plantar load
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Loads per unit of plantar segments
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Changes of loads during gait
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Gait-time graph
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Maximum and average pressures
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Plantar Contact area
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Plantar contact time
timeFrame: Before treatment, after 8 weeks, after 6 months
measure: Balance measurement
timeFrame: Before first treatment, after 8 weeks, and after 6 months
measure: Physical performance tests
timeFrame: Before first treatment, after 8 weeks, and after 6 months
measure: Multidimensional Nil Hallux Valgus Scale
timeFrame: Before first treatment, after 8 weeks, and after 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: