search
Back to results

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

Primary Purpose

Crossed Pelvis Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Personalized Insole Group
Placebo Group
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crossed Pelvis Syndrome focused on measuring Posture, Orthosis, Foot, Biomechanical Phenomena

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Personalized Insole Group

Placebo Group

Arm Description

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

The participants will use plane insoles.

Outcomes

Primary Outcome Measures

Posture
Photogrammetry in Corel Draw

Secondary Outcome Measures

Pain
Visual analog scale.
Moviment amplitude (hip joint, knee)
Goniometry
Lombar colune mobility
Schober test
Abdominal circunference
Roma test
Sacroiliac mobility
Standing flexion test and Gillet test

Full Information

First Posted
November 18, 2017
Last Updated
November 18, 2017
Sponsor
Universidade Federal de Pernambuco
search

1. Study Identification

Unique Protocol Identification Number
NCT03350867
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Anticipated)
Study Completion Date
December 20, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crossed Pelvis Syndrome
Keywords
Posture, Orthosis, Foot, Biomechanical Phenomena

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: a Personalized Insole Group and a Placebo Group.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Insole Group
Arm Type
Experimental
Arm Description
The participants will use insole with personalized support directed to your biomechanics necessities.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
The participants will use plane insoles.
Intervention Type
Other
Intervention Name(s)
Personalized Insole Group
Intervention Description
Personalized Insole Group
Intervention Type
Other
Intervention Name(s)
Placebo Group
Intervention Description
Placebo Group
Primary Outcome Measure Information:
Title
Posture
Description
Photogrammetry in Corel Draw
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Pain
Description
Visual analog scale.
Time Frame
45 days
Title
Moviment amplitude (hip joint, knee)
Description
Goniometry
Time Frame
45 days
Title
Lombar colune mobility
Description
Schober test
Time Frame
45 days
Title
Abdominal circunference
Description
Roma test
Time Frame
45 days
Title
Sacroiliac mobility
Description
Standing flexion test and Gillet test
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Pimentel, Bachelor
Phone
+5581998040297
Email
eduspimentel@hotmail.com
Facility Information:
Facility Name
Laboratory of learning and motor control; Federal University of Pernambuco (UFPE)
City
Recife
State/Province
PE
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Pimentel, Bachelor
Phone
+5581998040297
Email
eduspimentel@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs