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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03350867
Enrollment
15
Registered
2017-11-22
Start date
2017-08-09
Completion date
2017-12-20
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crossed Pelvis Syndrome

Keywords

Posture, Orthosis, Foot, Biomechanical Phenomena

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.

Interventions

OTHERPersonalized Insole Group

Personalized Insole Group

OTHERPlacebo Group

Placebo Group

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Posture45 daysPhotogrammetry in Corel Draw

Secondary

MeasureTime frameDescription
Pain45 daysVisual analog scale.
Moviment amplitude (hip joint, knee)45 daysGoniometry
Lombar colune mobility45 daysSchober test
Abdominal circunference45 daysRoma test
Sacroiliac mobility45 daysStanding flexion test and Gillet test

Countries

Brazil

Contacts

Primary ContactEduardo Pimentel, Bachelor
eduspimentel@hotmail.com+5581998040297

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026