HealthyNCT03816085
Shoes on Balance, Muscular Endurance and Functional Skills
A study testing Shoes in people with Healthy, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
In daily life, stiletto heeled shoes which are popularly preferred by women have different heel heights. This study aims to investigate the effects of these differences on balance, muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Shoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Dec 2018to 10 Mar 2019
- Phase
- Interventional
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- the shoe number will be 37
- women who do not regularly wear high heeled shoes
- women who are familiar with stiletto heeled shoes
Who cannot join
- any pain which prevents to participate in tests
- women with cardiovascular disease, metabolic disease, blood pressure disorders, diabetes diseases, neuromuscular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Shoes With Different Heel Heights on Balance, Muscular Endurance and Functional Skills
In daily life, stiletto heeled shoes which are popularly preferred by women have different heel heights. This study aims to investigate the effects of these differences on balance, muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Other features of shoes (stiletto type/colour etc.) will be same. The tests will be randomly done barefoot, 10 cm, and 4cm shoes.
Read the detailed description
The evaluations will include Functional Forward Reach Test for dynamic balance and Single Leg Standing for static balance, heel raising and squat-up test for muscular endurance of plantar flexor and quadriceps muscles, ascending stairs for functional skills.
Measuring distance will be used for Functional reach test and timing will be used for single leg standing test. Timing and repetition number will be used for muscular endurance tests. Timing will be used to climb up 10 stairs with and without heel contact.
- Conditions
- Healthy
- Being tested
- Shoes
- Keywords
- women, shoes, balance, muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShoesOther
Also called Women wearing shoes
Shoes with different heel heights
| Study group | Role | What they receive |
|---|---|---|
| Shoe with 4 cm heel | Experimental | Shoes with 4 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe. Receives: Other: Shoes |
| Shoe with 10 cm heel | Experimental | Shoes with 10 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe. Receives: Other: Shoes |
| Without shoes | No intervention | Women will be included in the tests to measure balance, muscular endurance and function without shoes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Skill
The case will be asked to climb up 10 stairs as fast as possible. Time (in seconds) will be recorded for climbing up with and without heel contact.
Measured: at baseline
Secondary outcomes (1)
Single Leg Standing
The case will be asked to stand on dominant leg. If the raised leg touches anything around (other limb, floor) or in condition of hopping/splashing, time will be stopped. Time (seconds) will be recorded.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start15 Dec 2018
- Primary completion15 Feb 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZEHRA GÜÇHAN TOPCU, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816085
- Sponsor's protocol ID
- ETK00-2018-0239
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2019
- Last updated
- 9 Jan 2020
- 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 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Shoes With Different Heel Heights on Balance, Muscular Endurance and Functional Skills
- ClinicalTrials.gov ID
- NCT03816085
- Acronym / sponsor ID
- ETK00-2018-0239
- Conditions
- Healthy
- Keywords
- women, shoes, balance, muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 25 Jan 2019 (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.
In daily life, stiletto heeled shoes which are popularly preferred by women have different heel heights. This study aims to investigate the effects of these differences on balance, muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Other features of shoes (stiletto type/colour etc.) will be same. The tests will be randomly done barefoot, 10 cm, and 4cm shoes.
Detailed description
The evaluations will include Functional Forward Reach Test for dynamic balance and Single Leg Standing for static balance, heel raising and squat-up test for muscular endurance of plantar flexor and quadriceps muscles, ascending stairs for functional skills.
Measuring distance will be used for Functional reach test and timing will be used for single leg standing test. Timing and repetition number will be used for muscular endurance tests. Timing will be used to climb up 10 stairs with and without heel contact.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shoe with 4 cm heel | Experimental | Other: ShoesShoes with 4 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe. |
| Shoe with 10 cm heel | Experimental | Other: ShoesShoes with 10 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe. |
| Without shoes | No intervention | –Women will be included in the tests to measure balance, muscular endurance and function without shoes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- the shoe number will be 37
- women who do not regularly wear high heeled shoes
- women who are familiar with stiletto heeled shoes
Key exclusion criteria (2 listed)
- any pain which prevents to participate in tests
- women with cardiovascular disease, metabolic disease, blood pressure disorders, diabetes diseases, neuromuscular diseases.
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 |
|---|---|---|
| ShoesAlso: Women wearing shoesShoes with different heel heights | Other | Shoe with 10 cm heel, Shoe with 4 cm heel |
Primary outcome
Functional Skill
Time frame: at baseline
The case will be asked to climb up 10 stairs as fast as possible. Time (in seconds) will be recorded for climbing up with and without heel contact.
1 secondary outcome
Single Leg Standing
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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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.
ZEHRA GÜÇHAN TOPCU principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoes in people with Healthy, run by Eastern Mediterranean University at 1 site in Cyprus.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Skill (time frame: at baseline). 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 9 Jan 2020.