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临床试验/NCT03350867
NCT03350867Unknown不适用

Effects of Using Customized Insoles With Anterior or Posterior Plantar Support in Cross-pelvis Syndrome and Perception of Body Alignment in Young Adults: a Randomized Clinical Trial

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年8月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
Posture

研究概览

简要总结

INTRODUCTION: Custom insoles with anterior or posterior support are described in the literature mainly for the treatment of foot and knee dysfunctions and this therapeutic effect extends to the promotion of biomechanical alignment between pelvis and trunk, by an ascending propceptive response. In this perspective, it can be hypothesized that the use of these insoles may favor individuals with anterior and posterior cross pelvis syndrome, who have biomechanical imbalance in the pelvis segment. To date, there is no literature data on the effect of continuous, noninvasive and inexpensive therapy on this individual profile.

OBJECTIVE: To evaluate the effects of using customized insoles with anterior or posterior plantar support in cross pelvis syndrome and in perception of body alignment in young adults.

METHODS: This is a blinded randomized controlled trial in individuals of both sexes aged 18-25 years and functionally diagnosed with posterior or anterior pelvic syndrome. Excluding thoracic deformities, lower limb differences, diabetic neuropathy, previous reports of some specific surgeries and treatment of ongoing physiotherapy. A pilot study will be carried out with 20 individuals divided into two groups for sample calculation (Personalized Insole Group and Placebo Group). After the pilot study, an initial screening will be carried out to verify the eligibility criteria. For the eligible, the pre-intervention evaluation will be carried out, which will be contemplated by personal data; scale of presence and intensity of pain; foot health status; foot posture index; by ely and thomas hamstring tests associated with an inclinometer and by photogrammetry. Individuals will be randomized into blocks of 10 individuals. A day will be marked to make the insole, in which the researcher will make the adaptations based on the biomechanical evaluation of the volunteer. To the invidious with the posterior cross pelvis syndrome an anterior support will be made in the insole and for those with anterior cross pelvis syndrome a posterior support will be made in the insole. For the placebo group, the insole will be made of the same material as that of the custom insoles, although, without support.

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

Double (Participant, Outcomes Assessor) The one who assess the patients in the beginning and in the final moment (investigator) not know what group the patient is. The participants don't know if they are using a placebo or personalized insole.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Crossed pelvis syndrome (anterior or posterior)
  • •Difference in length leg ≤ 1cm
  • •Don't show: scoliotic or kyphotic deformity; chirurgie or fracture in spine in last 12 months; thoracic chirurgie; diabetic neuropathy; cesarean surgery; mixed crossed pelvis syndrome
  • •Not participating in any physical activity or physiotherapy

排除标准

  • •Join in other physical activity during the study
  • •Refuse to wear the insoles

研究组 & 干预措施

Placebo Group

Placebo Comparator

The participants will use plane insoles.

干预措施: Placebo Group (Other)

Personalized Insole Group

Experimental

The participants will use insole with personalized support directed to your biomechanics necessities.

干预措施: Personalized Insole Group (Other)

结局指标

主要结局

Posture

时间窗: 45 days

Photogrammetry in Corel Draw

次要结局

  • Pain(45 days)
  • Moviment amplitude (hip joint, knee)(45 days)
  • Lombar colune mobility(45 days)
  • Abdominal circunference(45 days)
  • Sacroiliac mobility(45 days)

研究者

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

Eduardo Augusto dos Santos Pimentel

Eduardo Augusto Dos Santos Pimentel

Universidade Federal de Pernambuco

研究点 (1)

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