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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

NCT ID: NCT03350867

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-09

Study Completion Date

2017-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Crossed Pelvis Syndrome

Keywords

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Posture Orthosis Foot Biomechanical Phenomena

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups: a Personalized Insole Group and a Placebo Group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Personalized Insole Group

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

Group Type EXPERIMENTAL

Personalized Insole Group

Intervention Type OTHER

Personalized Insole Group

Placebo Group

The participants will use plane insoles.

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type OTHER

Placebo Group

Interventions

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Personalized Insole Group

Personalized Insole Group

Intervention Type OTHER

Placebo Group

Placebo Group

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Augusto dos Santos Pimentel

Eduardo Augusto Dos Santos Pimentel

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laboratory of learning and motor control; Federal University of Pernambuco (UFPE)

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Eduardo Pimentel, Bachelor

Role: CONTACT

Phone: +5581998040297

Email: [email protected]

Facility Contacts

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Eduardo Pimentel, Bachelor

Role: primary

Other Identifiers

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Insole and cross-pelvis synd.

Identifier Type: -

Identifier Source: org_study_id