Impact of Different Heel Heights on Spinal ConfigurationNCT03688750
Impact of Different Shoe Heel Heights on Spinal Configuration
An observational study of Impact of Different Heel Heights on Spinal Configuration, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Impact of Different Heel Heights on Spinal Configuration
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 90 healthy females with regular menstrual cycle
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- no intervention
- Keywords
- heel height, spinal configuration, phases of menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: from 9/2018 to 6/2019
pelvic inclination
it is calculated as the mean torsion of the dimple left and dimple right surface normals
Measured: from 9/2018 to 6/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study startJul 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Different Heel Heights on Spinal ConfigurationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAhmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688750
- Sponsor's protocol ID
- P.T.REC/012/001884
- Status last verified
- Nov 2018
- First submitted
- 2 Sep 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Shoe Heel Heights on Spinal Configuration During Different Phases of Menstrual Cycle
- ClinicalTrials.gov ID
- NCT03688750
- Acronym / sponsor ID
- P.T.REC/012/001884
- Keywords
- heel height, spinal configuration, phases of menstrual cycle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 90 healthy females with regular menstrual cycle
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | – |
Primary outcome
kyphotic angle
Time frame: from 9/2018 to 6/2019
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
Lordotic angle
Time frame: from 9/2018 to 6/2019
this the maximum angle measured between surface tangents of the thoracic lumbar inflection point and lower lumbar-sacral inflection point
trunk imbalance
Time frame: from 9/2018 to 6/2019
trunk imbalance is defined as the lateral deviation of the vertebra prominence from the mid line dimple
trunk inclination
Time frame: from 9/2018 to 6/2019
trunk inclination refers to a difference in the height between vertebra prominence and dimple mid line based on a vertical plane (sagittal section)
pelvic tilting
Time frame: from 9/2018 to 6/2019
pelvic tilt refers as the difference in the height of the lumbar dimple based on horizontal plane ( transverse section)
pelvic inclination
Time frame: from 9/2018 to 6/2019
it is calculated as the mean torsion of the dimple left and dimple right surface normals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Impact of Different Heel Heights on Spinal Configuration, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kyphotic angle (time frame: from 9/2018 to 6/2019). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.