Impact of Different Shoe Heel Heights on Spinal Configuration

Impact of Different Shoe Heel Heights on Spinal Configuration During Different Phases of Menstrual Cycle

90 healthy female subjects with regular menstrual cycle ,their ages ranged from 19-25 years,their BMI ranged from 18-25 will be participated in this study.

Formetric Raster Stereography will be used to assess spinal configuration while each participant wear shoes of different heel heights 2.5 cm (low),4.5 cm (moderate) and 7 cm (height) during early follicular and mid luteal phases of menstrual cycle.

Study Overview

• Status: Unknown
• Conditions: Impact of Different Heel Heights on Spinal Configuration
• Intervention / Treatment: Other: no intervention

Detailed Description

• this study will be conducted on healthy females to investigate effect of different heel heights footwear on spine posture and pelvic position by using formetric 4 D analysis system which is a light-optical scanning method based on Video-Raster-Stereography (VRS). Accordingly, the system consists of a light projector which projects a line grid on the back of the patient which is recorded by an imaging unit. A computer software analyzes the line curvature that generates from it. the formetric provides comprehensive information about the whole body statics and posture in only one measuring process, e.g. spine curvature (lateral and frontal), vertebral rotation, and pelvic position.
• There is generally no need for reflecting markers, because the anatomical fixed points Vertebra prominens (VP), Sacrum Point (SP), Dimple Left (DL) Dimple Right (DR) as well as the spinal center line and spinal rotation are automatically detected by the system. That allows a very time-saving and reliable examination procedure.
• shoe characteristics: standard shoes will be used and designed to fit females in sizes ranging from 37-41 and different heel heights (2.5 cm low, 4,5 cm moderate and 7 cm high).
• Descriptive statistics including mean and standard deviation will be applied for dependent variables and participant demographics. repeated measures analysis of variance will be implemented to detect the difference in dependent measures among three heel condition.

• Study Type: Observational
• Enrollment (Anticipated): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

90 healthy females with regular menstrual cycle

Description

Inclusion Criteria:

• Their ages ranged from 19-25.
• Their BMI ranged from 18-25
• They wear high heeled shoes occasionally for less than 10 H/week or not at all
• they are able to wear high heel without pain.

Exclusion Criteria:

• any female with spinal deviation,previous spinal surgeries,leg length discrepancy or foot deformities
• Joint stiffness, ankle sprain
• any case with orthopedic or neurological problems
• Females with irregular menstrual cycle

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kyphotic angle	this the maximum angle measured between surface tangents of the upper inflection point in the vicinity of the vertebra prominence and the thoracic lumbar inflection point	from 9/2018 to 6/2019
Lordotic angle	this the maximum angle measured between surface tangents of the thoracic lumbar inflection point and lower lumbar-sacral inflection point	from 9/2018 to 6/2019
trunk imbalance	trunk imbalance is defined as the lateral deviation of the vertebra prominence from the mid line dimple	from 9/2018 to 6/2019
trunk inclination	trunk inclination refers to a difference in the height between vertebra prominence and dimple mid line based on a vertical plane (sagittal section)	from 9/2018 to 6/2019
pelvic tilting	pelvic tilt refers as the difference in the height of the lumbar dimple based on horizontal plane ( transverse section)	from 9/2018 to 6/2019
pelvic inclination	it is calculated as the mean torsion of the dimple left and dimple right surface normals	from 9/2018 to 6/2019

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: September 2, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: heel height; spinal configuration; phases of menstrual cycle
• Other Study ID Numbers: P.T.REC/012/001884

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No