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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

NCT03350867 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-11-22

No results posted yet for this study

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.

Conditions

  • Crossed Pelvis Syndrome

Interventions

OTHER

Personalized Insole Group

Personalized Insole Group

OTHER

Placebo Group

Placebo Group

Sponsors & Collaborators

  • Universidade Federal de Pernambuco

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-09
Primary Completion
2017-12-20
Completion
2017-12-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350867 on ClinicalTrials.gov