- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816085
Shoes on Balance, Muscular Endurance and Functional Skills
The Effects of Shoes With Different Heel Heights on Balance, Muscular Endurance and Functional Skills
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Famagusta, Cyprus, 99628
- Zehra Güçhan Topcu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- the shoe number will be 37
- women who do not regularly wear high heeled shoes
- women who are familiar with stiletto heeled shoes
Exclusion Criteria:
- any pain which prevents to participate in tests
- women with cardiovascular disease, metabolic disease, blood pressure disorders, diabetes diseases, neuromuscular diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Shoe with 4 cm heel
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.
|
Shoes with different heel heights
Other Names:
|
|
Experimental: Shoe with 10 cm heel
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.
|
Shoes with different heel heights
Other Names:
|
|
No Intervention: Without shoes
Women will be included in the tests to measure balance, muscular endurance and function without shoes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single Leg Standing
Time Frame: at baseline
|
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.
|
at baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repetition number of heel raising
Time Frame: at baseline
|
Before the test, the case will be asked to stretch plantar flexor muscles.
Then the case will be asked to raise the heels unilaterally.
The repetition number will be written until the case cannot do the full movement.
|
at baseline
|
|
Repetition number of squating
Time Frame: at baseline
|
Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee.
Then the case will be asked to squat continuously.
The repetition number will be written until the case cannot do the full movement.
|
at baseline
|
|
Duration of heel raising
Time Frame: at baseline
|
Before the test, the case will be asked to stretch plantar flexor muscles.
Then the case will be asked to raise the heels unilaterally.
The time (in seconds) will be written until the case cannot do the full movement.
|
at baseline
|
|
Duration of squating
Time Frame: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
|
Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee.
Then the case will be asked to squat continuously.
The time (in seconds) will be written until the case cannot do the full movement.
|
Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
|
|
Functional Forward Reach Test
Time Frame: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
|
Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee.
Then the case will be asked to squat continuously.
The repetition number will be written until the case cannot do the full movement.
|
Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ZEHRA GÜÇHAN TOPCU, Eastern Mediterranean University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Shoes
-
Assistance Publique - Hôpitaux de ParisSorbonne UniversityNot yet recruitingChronic Obstructive Pulmonary Disease (COPD) | Exercise Intolerance | DyspnoeaFrance
-
University Hospital, BrestCompleted
-
University Hospital, Basel, SwitzerlandCompletedCerebral PalsySwitzerland
-
University Hospital, GenevaCompleted
-
Assaf-Harofeh Medical CenterUnknownCerebral Palsy | Poststroke/CVA ParesisIsrael
-
IRCCS National Neurological Institute "C. Mondino...Not yet recruitingParkinson Disease | Gait Disorders
-
Assistance Publique - Hôpitaux de ParisMaison LLAFIANot yet recruitingStroke | Disability Physical | Spasticity as Sequela of Stroke | Hemiplegia Following Ischemic Stroke | Equinovarus Foot | Gluteus Maximus Muscle Atrophy
-
University of LiverpoolLiverpool University Hospitals NHS Foundation TrustCompletedAging | FallsUnited Kingdom
-
University of MalagaActive, not recruiting
-
Centre Hospitalier Universitaire de Saint EtienneCompleted