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Clinical Trials/NCT03350867
NCT03350867
Unknown
Not Applicable

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 site in 1 country15 target enrollmentAugust 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Crossed Pelvis Syndrome
Sponsor
Universidade Federal de Pernambuco
Enrollment
15
Locations
1
Primary Endpoint
Posture
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 9, 2017
End Date
December 20, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eduardo Augusto dos Santos Pimentel

Eduardo Augusto Dos Santos Pimentel

Universidade Federal de Pernambuco

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Posture

Time Frame: 45 days

Photogrammetry in Corel Draw

Secondary Outcomes

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

Study Sites (1)

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