- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350867
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eduardo Pimentel, Bachelor
- Phone Number: +5581998040297
- Email: eduspimentel@hotmail.com
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Personalized Insole Group
|
Placebo Comparator: Placebo Group
The participants will use plane insoles.
|
Placebo Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posture
Time Frame: 45 days
|
Photogrammetry in Corel Draw
|
45 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 45 days
|
Visual analog scale.
|
45 days
|
Moviment amplitude (hip joint, knee)
Time Frame: 45 days
|
Goniometry
|
45 days
|
Lombar colune mobility
Time Frame: 45 days
|
Schober test
|
45 days
|
Abdominal circunference
Time Frame: 45 days
|
Roma test
|
45 days
|
Sacroiliac mobility
Time Frame: 45 days
|
Standing flexion test and Gillet test
|
45 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Insole and cross-pelvis synd.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crossed Pelvis Syndrome
-
Cairo UniversityNot yet recruitingUpper Crossed Syndrome
-
Riphah International UniversityRecruiting
-
Cairo UniversityNot yet recruiting
-
Cairo UniversityCompleted
-
Cairo UniversityNot yet recruitingKyphosis | Neck Muscle Issue
-
Riphah International UniversityRecruitingLow Back PainPakistan
-
Cairo UniversityCompletedPostural; DefectEgypt
-
University of SouthamptonEnrolling by invitationPostoperative Complications | Rectal Cancer | Pelvic Cancer | Pelvic Neoplasm | Pelvic Exenteration | Empty Pelvis SyndromeUnited Kingdom
-
University of Alabama at BirminghamBayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaCompletedUrothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)United States
-
Afyonkarahisar Health Sciences UniversityActive, not recruitingGait | Anatomy | Pelvis | MorphologyTurkey
Clinical Trials on Personalized Insole Group
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUnknown
-
National Taipei University of Nursing and Health...Completed
-
Federal University of São PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedChronic Nonspecific Low Back PainBrazil
-
Mahidol UniversityRecruitingPlantar Fascitis | Fasciitis, Plantar, ChronicThailand
-
Technological Centre of Nutrition and Health, SpainUniversity Rovira i Virgili; Hospital Universitari Sant Joan de Reus; Horizon... and other collaboratorsCompletedDietary Habits | Personalized Nutrition | Health StatusSpain
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUnknown
-
University of MelbourneNational Health and Medical Research Council, AustraliaCompletedOsteoarthritisAustralia
-
Staffordshire UniversityKing's College Hospital NHS TrustNot yet recruiting
-
Federal University of São PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedMorton Neuroma
-
Reckitt Benckiser Healthcare (UK) LimitedSynteractHCR Deutschland GmbHTerminatedMusculoskeletal PainUnited Kingdom