Clinical trial NCT03688750: Impact of Different Shoe Heel Heights on Spinal Configuration
Official title: Impact of Different Shoe Heel Heights on Spinal Configuration During Different Phases of Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Impact of Different Heel Heights on Spinal Configuration
Keywords: heel height
spinal configuration
phases of menstrual cycle
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90 healthy females with regular menstrual cycle

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: kyphotic angle
timeFrame: from 9/2018 to 6/2019
measure: Lordotic angle
timeFrame: from 9/2018 to 6/2019
measure: trunk imbalance
timeFrame: from 9/2018 to 6/2019
measure: trunk inclination
timeFrame: from 9/2018 to 6/2019
measure: pelvic tilting
timeFrame: from 9/2018 to 6/2019
measure: pelvic inclination
timeFrame: from 9/2018 to 6/2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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