Crossed Pelvis Syndrome 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
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.
| Status | Recruiting |
| Enrollment | 15 |
| Est. completion date | December 20, 2017 |
| Est. primary completion date | December 20, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 25 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Laboratory of learning and motor control; Federal University of Pernambuco (UFPE) | Recife | PE |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Federal de Pernambuco |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Posture | Photogrammetry in Corel Draw | 45 days | |
| Secondary | Pain | Visual analog scale. | 45 days | |
| Secondary | Moviment amplitude (hip joint, knee) | Goniometry | 45 days | |
| Secondary | Lombar colune mobility | Schober test | 45 days | |
| Secondary | Abdominal circunference | Roma test | 45 days | |
| Secondary | Sacroiliac mobility | Standing flexion test and Gillet test | 45 days |