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 | Unknown DMC

• 1 other identifier: Insole and cross-pelvis synd.
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Crossed Pelvis Syndrome

Keywords

Posture; Orthosis; Foot; Biomechanical Phenomena

Outcome Measures

Primary Outcomes (1)

• Posture

  Photogrammetry in Corel Draw

  45 days

Secondary Outcomes (5)

• Pain

  45 days

• Moviment amplitude (hip joint, knee)

  45 days

• Lombar colune mobility

  45 days

• Abdominal circunference

  45 days

• Sacroiliac mobility

  45 days

Study Arms (2)

Personalized Insole Group

EXPERIMENTAL

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

Other: Personalized Insole Group

Placebo Group

PLACEBO COMPARATOR

The participants will use plane insoles.

Other: Placebo Group

Interventions

Personalized Insole Group OTHER

Personalized Insole Group

Personalized Insole Group

Placebo Group OTHER

Placebo Group

Placebo Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

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

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Central Study Contacts

Eduardo Pimentel, Bachelor

CONTACT

+5581998040297; eduspimentel@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eduardo Augusto Dos Santos Pimentel

Model Details: Two groups: a Personalized Insole Group and a Placebo Group.

Study Record Dates

• First Submitted: November 18, 2017
• First Posted: November 22, 2017
• Study Start: August 9, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

BR (1)