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临床试验/NCT06672796
NCT06672796尚未招募不适用

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.

Bahar Anaforoglu0 个研究点目标入组 42 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42
主要终点
Balance measurement

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

CG

Active Comparator

8 weeks, stretching exercise

干预措施: Stretching exercise (Other)

SEG

Active Comparator

8 weeks, stretching exercise and toe spread out standart protocol

干预措施: Toe Spread Out Exercise (Other)

SEG

Active Comparator

8 weeks, stretching exercise and toe spread out standart protocol

干预措施: Stretching exercise (Other)

REG

Experimental

8 weeks, stretching exercise and resisted concentric and eccentric contraction protocol of toe spread out exercise

干预措施: Resisted Toe Spread Out Exercise (Other)

REG

Experimental

8 weeks, stretching exercise and resisted concentric and eccentric contraction protocol of toe spread out exercise

干预措施: Stretching exercise (Other)

结局指标

主要结局

Balance measurement

时间窗: Before first treatment, after 8 weeks, and after 6 months

Y-balance test

Mediolateral Width

时间窗: Before treatment, after 8 weeks, after 6 months

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

Shear Wave Elastography

时间窗: Before treatment, after 8 weeks, after 6 months

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

Plantar load

时间窗: Before treatment, after 8 weeks, after 6 months

Measurement with plantar pressure distrubiton analysis (kg/cm²)

Loads per unit of plantar segments

时间窗: Before treatment, after 8 weeks, after 6 months

Measurement with plantar pressure distrubiton analysis (kg/cm²)

Changes of loads during gait

时间窗: Before treatment, after 8 weeks, after 6 months

Measurement with plantar pressure distrubiton analysis (kg/cm²)

Gait-time graph

时间窗: Before treatment, after 8 weeks, after 6 months

Measurement with plantar pressure distrubiton analysis (%)

Maximum and average pressures

时间窗: Before treatment, after 8 weeks, after 6 months

Measurement with plantar pressure distrubiton analysis (kg/cm²)

Plantar Contact area

时间窗: Before treatment, after 8 weeks, after 6 months

Measurement with plantar pressure distrubiton analysis (cm²)

Plantar contact time

时间窗: Before treatment, after 8 weeks, after 6 months

Measurement with plantar pressure distrubiton analysis (msn)

Physical performance tests

时间窗: Before first treatment, after 8 weeks, and after 6 months

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

Hallux Valgus Angle

时间窗: Before treatment, after 6 months

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

Intermetatarsal angle

时间窗: Before treatment, after 6 months

A radiographic measurement (°) The term intermetatarsal angle alone typically refers to assessment of the first and second metatarsals

Hallux Interphalangeal Angle

时间窗: 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.

Distal Metatarsal Articular Angle

时间窗: 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.

Sesamoid Position Classification

时间窗: 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.

Length of the First Metatarsal

时间窗: Before treatment, after 6 months

A radiographic measurement Length of the first metarsal (centimeter)

Surface Electromyography

时间窗: Before first treatment, after 8 weeks, and after 6 months

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

Cross Sectional Area

时间窗: 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

Dorsoplantar Thickness

时间窗: Before treatment, after 8 weeks, after 6 months

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

Multidimensional Nil Hallux Valgus Scale

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Bahar Anaforoglu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bahar Anaforoglu

Associate Professor

Ankara Yildirim Beyazıt University

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