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

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.

Study Overview

• Status: Unknown
• Conditions: Crossed Pelvis Syndrome
• Intervention / Treatment: Other: Personalized Insole Group; Other: Placebo Group

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Pimentel, Bachelor; Phone Number: +5581998040297; Email: eduspimentel@hotmail.com

Study Locations

• Brazil
  • PE
    • Recife, PE, Brazil, 50670-901
      • Recruiting
      • Laboratory of learning and motor control; Federal University of Pernambuco (UFPE)
      • Contact: Eduardo Pimentel, Bachelor; Phone Number: +5581998040297; Email: eduspimentel@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Insole Group; The participants will use insole with personalized support directed to your biomechanics necessities.	Other: Personalized Insole Group; Personalized Insole Group
Placebo Comparator: Placebo Group; The participants will use plane insoles.	Other: Placebo Group; Placebo Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posture	Photogrammetry in Corel Draw	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Visual analog scale.	45 days
Moviment amplitude (hip joint, knee)	Goniometry	45 days
Lombar colune mobility	Schober test	45 days
Abdominal circunference	Roma test	45 days
Sacroiliac mobility	Standing flexion test and Gillet test	45 days

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Anticipated): December 20, 2017
• Study Completion (Anticipated): December 20, 2017

Study Registration Dates

• First Submitted: November 18, 2017
• First Submitted That Met QC Criteria: November 18, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 18, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Posture; Foot; Orthosis; Biomechanical Phenomena
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Insole and cross-pelvis synd.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No