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临床试验/NCT06313125
NCT06313125已完成不适用

Comparison of Effects Three-Dimensional Foot-Ankle Exercise and Hip Abductor and External Rotator Strengthening Exercise With Flexible Flatfoot Individuals: Randomized Controlled Study

Mustafa Kemal University2 个研究点 分布在 2 个国家目标入组 56 人开始时间: 2024年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Medial longitudinal arch height-Navicular Drop Test

研究概览

简要总结

Flexible flatfoot deformity, also known as flexible pes planus, is a common pathological condition characterized by decreased medial longitudinal arch height, eversion of the calcaneus and abduction of the forefoot, especially during loading. Conservative treatments are generally considered as the first step in treatment. In conservative treatments, exercise methods are one of the most frequently used interventions. It has been reported that exercise can improve functional outcomes such as navicular drop, plantar pressure distribution, foot posture, balance, and muscle strength in adults with flexible flatfoot. Although it is known that intrinsic muscle strengthening exercises are a frequently used intervention method in foot pathologies, there is a deficiency in the literature regarding studies investigating the effect of the combination of the most basic foot intrinsic muscle strengthening exercises with different exercise interventions on targeted clinical gains. However, the effect of three-dimensional foot-ankle exercise on flat feet is unknown. Additionally, there are a limited number of studies in the literature investigating the effects of hip abductor and external rotator muscle strength training on foot posture in individuals with flat feet. The aim of this thesis study, planned in the light of this information, is to determine the effects of three-dimensional foot-ankle extension exercises and hip abductor-external rotator muscle strengthening exercise primarily on navicular drop and MLA height in individuals with flexible flat feet; Secondly, it is to examine and compare the effects of static foot posture, hip abductor/external rotator, ankle circumference and intrinsic muscle strength on the functional performance of the lower extremity (endurance, dynamic balance and single leg forward jumping performance). To our knowledge, this study will be the first randomized controlled study to examine and compare the effects of two different exercise interventions that exercise the proximal and distal regions in flatfoot rehabilitation, and the results obtained will contribute to the development of better exercise and treatment programs in this population. In individuals with flat feet, when hip abductor/external rotator strengthening exercises or 3D foot-ankle extension exercises in the PNF pattern are added to short-foot exercise, MLA structure, muscle strength and lower extremity function will be improved more, and when these exercises are combined with short-foot exercise, they are comparable to intrinsic muscle strengthening exercises alone. The investigators hypothesized that it would produce superior clinical results.

详细描述

This study was designed as an experimental, 3-arm, parallel group, single-blind randomized controlled study that included a 6-week intervention period. The study will be carried out in the university physiotherapy and exercise laboratory. Flat-footed individuals aged between 18-50 years will be included in this study. G-Power (Windows version 3.1.9.7) statistical program was used to determine the number of participants. Sample size calculation was made based on a similar study in the literature that evaluated the amount of navicular drop after foot intrinsic muscle strength training (the primary outcome measure of this study). Type 1 error probability 0.01; The power was accepted as 0.90 and the number of samples was determined as at least 15 people for each group. By adding the 20% loss rate to this number, it was decided that the required number of participants would be 20 people in total for each group. Participants who were confirmed to be included in the study were evaluated by the lead investigator, who was not involved in the evaluations, using Random Allocation Software (version 2.0) in a single block format, 3-dimensional foot-ankle exercise group (foot muscle exercise group, AEG), hip abductor and external rotator strengthening exercise. will be allocated to three different groups: group (hip muscles exercise group, KEG) and control group (CG). The investigator performing the assessments will be blinded to group allocation. Recording of groups' demographic information and assessment of outcome measures will be performed by a secondary investigative physical therapist who is blinded to group information. The principal investigator physiotherapist will be responsible for training the participants to perform the exercises assigned to them, communicating with the participants to monitor exercise performance and exercise compliance, allocating the groups and ensuring blinding. Outcome measurements will be repeated at the start of treatment and at the end of treatment.

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 (Participant, Outcomes Assessor)

盲法说明

The evaluator researcher and participants will be blinded to group allocation.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range is 18-50 years
  • Navicular drop amount is 10 mm or more
  • Getting a value of +6 points or above from the Foot Posture Index

排除标准

  • Orthopedic and rheumatological diseases of the spinal region and lower extremities
  • Surgery history of the spine and lower extremities
  • Neurological and systemic disorders
  • Describing lower extremity and/or lower back pain in the last 6 months
  • Disorders that may affect cognitive and balance (otitis media, visual impairment, etc.)
  • Having received any physiotherapy and rehabilitation treatment for flat feet or hips in the last year
  • Body mass index being above normal values (18-24.9 kg/m2)
  • Having rigid flat feet and hallux rigidus-limitus deformity
  • Doing regular sports or exercise

结局指标

主要结局

Medial longitudinal arch height-Navicular Drop Test

时间窗: 6 weeks

To detect flatfoot MLA height will be evaluated by the Navicular Drop Test. According to this test result, if the MLA height is between 5-9 mm, the foot is in neutral position; If it is 4 mm or lower, the foot is in supination; If the value is 10 mm or more, a classification can be made as the foot is in pronation. This result will also be used when determining the inclusion criteria, and values of 10 mm and above will be interpreted as low arc.

次要结局

  • Static foot posture-Foot Posture Index-6(6 weeks)
  • Foot structure-Photopodometric analysis(6 weeks)
  • Recording demographic and clinical information on the evaluation form(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Hande Esen

MSc, PT, Principal Investigator

Toros University

研究点 (2)

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