NCT04377373

Brief Summary

Many patients with genu valgum present with postural changes, such as: internal rotation of the tibial and femoral axes, anteversion of the iliac bones, increased lumbar lordosis, thoracic hyperkyphosis and cervical hyperlordosis. Such pathomechanical changes may interfere with lumbar range of motion. Investigators of this study try to answer the following question: is there a relationship between sacral angle and lumbar range of motion in women with bilateral genu valgum. the results of this study will help professionals to plan a proper treatment program for patients with genu valgum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

September 6, 2019

Last Update Submit

May 5, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sacral angle

    After X-ray lateral view for lumbo-sacral spine, the investigators used a 30 cm long transparent ruler to measure the sacral angle on the X-ray film. Two lines were drawn, the first line along the superior margin of the sacrum, and the second line was the horizontal line. The acute angle between 2 lines(sacral angle) was measured in degrees using a protractor.

    30 minutes

  • Lumbar range of motion measured by Modified Shobber test

    * Patient was directed to stand with the back exposed. * Dimples of Venus (posterior superior iliac spine) was determined and was marked by pertinent marker. * Using tape measurement, the researcher marked a point 5 cm below and 10 cm above marked dimples (total marked area was 15 cm). * Then the subject was asked to lean forward without bending the knees. * The distance between 2 points was measured (D), then the ROM was determined by the following equation; ROM = D -15.

    15 minutes

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female with bilateral genu valgum with age range 18-25 and BMI≥ 30 (kg/m2)

You may qualify if:

  • Female with bilateral genu valgum (Q angle\> 20 degrees.
  • Age ranges from 18-25 years old.
  • BMI ≥ 30 (kg/m2)

You may not qualify if:

  • Previous lumbar surgery
  • lumbar spine fracture
  • Spondylolisthesis
  • Foraminal or extra foraminal lumbar disc herniation
  • spinal tumors, and bone metabolic diseases 6 - Knee surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Genu Valgum

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Nasr A. Abdelkader, PhD

    Lecturer,Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 6, 2019

First Posted

May 6, 2020

Study Start

April 14, 2019

Primary Completion

August 15, 2019

Study Completion

September 5, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations