Gait Stability, Postural StabilityNCT04772339
Effects of Foot Core Muscles Endurance and Fatigue on Postural Stability and Gait Stability
An observational study of Gait Stability, Postural Stability, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
While walking, fatigue, sensorimotor function and motor control can affect in many ways. This research focuses on the relationship between foot core muscles with balance and gait parameters. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Stability, Postural Stability
- What is being tested?
- Heel-Rise Test and Paper Grip Test (PGT)
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2021to 15 Jun 2021
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults aged between 18-30 within the normal BMI range by standards of WHO.
Who may be able to join
- Being in the age range of 18-30
- Being within the limits of body mass index (weight / height2: 18.5-24.9 kg / m2) accepted as normal BMI by the World Health Organization
- To have the ability to speak and understand Turkish
- Agree to participate in the study
Who cannot join
- To be screened with any medical pre-diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
- Being monitored with any medical diagnosis (orthopedic, neurological, cardiovascular, psychiatric etc.)
- Taking medication during the research
- Having consumed alcohol in the past 48 hours
- Taking pain medication in the past 48 hours
- Having a history of surgery or acute trauma in the last 6 months
- Having a fall for any reason within the last 1 year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University, Faculty of Health Sciences
Edirne, 22000
About this study
Official title: The Investigation of the Effects of Foot Core Muscles Endurance and Fatigue Resistance of These Muscles on Postural Stability and Gait Stability in Different Conditions
While walking, fatigue, sensorimotor function and motor control can affect in many ways. This research focuses on the relationship between foot core muscles with balance and gait parameters. The main purpose of the project is to investigate the effect of the endurance and fatigue responses of the extrinsic and intrinsic foot core muscles and the isolated fatigue response of the tibialis posterior muscle on balance and gait parameters.
Read the detailed description
The foot core system is responsible for the stability and dynamic and static function of the foot. Foot core muscles are part of the sub-systems that make up this system. Fatigue affects the basic characteristics of the sensorimotor system and impairs the accuracy of the voluntary movement. While walking, fatigue, sensorimotor function and motor control can affect in many ways. This research focuses on the relationship between foot core muscles with balance and gait parameters. The main purpose of the project is to investigate the effect of the endurance and fatigue responses of the extrinsic and intrinsic foot core muscles and the isolated fatigue response of the tibialis posterior muscle on balance and gait parameters.
The method of the project was established to investigate the effects of foot core muscles on balance and gait parameters. Demographic and basic physical characteristics of the participants (age, dominant hand, height, weight, education, marital status) will be taken and individuals with normal BMI will be included in the study. Each individual will walk on the treadmill for at least 512 steps at the rate he/she will have at his own pace. Then the individual will rest. Then the gait test on the 10% slope will be repeated and the individual will rest at the end of the test. The balance of individuals' will be evaluated with Y balance test after the resting process is ended. The Heel Rise test will be used to measure the endurance of the tibialis posterior muscle. The test will be repeated separately for both feet. Then the individual will be put on the gait and balance tests. The individual will be recalled the next day and the paper grip test will be performed to measure the total endurance of the foot core muscles. Then the individual will be put on the gait and balance tests.
With this research; the relationship between the endurance and fatigue responses of the foot core muscles, which have an important role in the protection and support of the foot arches and which perform this function with tonic contraction in daily life, will be determined. In this way, the results of the research will provide information to explain the gait cycle. We believe that with an original study we may support the development of rehabilitation processes for individuals who have gait problems or who are at risk of falling.
- Conditions
- Gait Stability, Postural Stability
- Being tested
- Heel-Rise Test, Paper Grip Test (PGT)
- Keywords
- Foot Core Muscles, Balance, Fatigue, Gait
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heel-Rise TestOther
The Heel Rise test for endurance will be performed while the participant stands on a box with 10 ° inclination on one leg. Participants will be allowed to get support from the wall at the point at shoulder level with two fingertips in order to maintain balance. A metronome of 30 beats per minute will be used to maintain the heel-rise frequency every 2 seconds. The participant will be asked to rise as high as possible with each heel rise, then lower the heel to the starting position, and with the next warning, he/she will be asked again. The participant will be asked to adapt to the pace of the metronome as much as possible and to continue the test as much as possible. The test will be terminated when the participant stops, fails to maintain frequency, or performs a proper heel raise. The number of heel raises obtained at the end of the test will be used for data analysis.
Paper Grip Test (PGT)Other
In the paper grip test, a paper is placed under the individual's thumb and the person is asked to squeeze this paper strongly between the big toe and the ground. The paper is pulled by the person performing the test and the individual is asked to hold the paper with his/her thumb as much as he/she can. When the person applies the maximum force, the height of the medial longitudinal arch is measured with a digital caliper in millimeters. The time that the individual can maintain the MLA height with this maximum force is recorded with a stopwatch.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Healthy adults aged between 18-30 Receives: Other: Heel-Rise Test; Other: Paper Grip Test (PGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis
Gait will be evaluated by a sensor gait analysis system. Sensors of this system are attached to the shoes of the individual and do not touch the skin. Each individual will freely walk on the treadmill for a period of time to achieve at least 512 steps at his/her own pace. To find the preferred walking speed of the individual, we will use the Hinton et al. protocol (Hinton et al., 2018). After the speed is determined, the individual will be provided to practice walking at this speed for 4-5 minutes. Then the walk will continue until at least 512 steps required for gait analysis are collected. After reaching the sufficient number of steps, the individual will be asked to slow down and stop walking. Then the individual will be taken to rest. The rest period will be determined according to the preference of the individual. Then the gait test will be repeated on 10% inclined ground and at the end of the test, the individual will rest again.
Measured: It will be recorded at baseline, after the heel-rise test and after the paper-grip test
Y Balance Test
In the test setup, 3 length gauges (tape measure) are fixed on the non-slip surface to make an angle of 120 degrees with each other. The participant will be asked to stand on one leg of his/her choice at the intersection of these 3 measuring tapes, and to reach out with his/her toe in 3 directions with the other foot: anterior, posteromedial, and posterolateral. In the meantime, attention will be paid to ensure that the participant does not lose his balance, the heel of the foot on which he is standing does not rise from the ground, and the toes of the extended foot are just slightly touching the ground. This application will be repeated 3 times for each direction, averaged and recorded in cm, and the total score will be determined by proportioning the individual's functional leg length (trochanter major and ground distance).
Measured: It will be recorded 5 minues after the gait analysis at baseline, after heel-rise test and after paper-grip test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start8 Feb 2021
- Primary completion8 Apr 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Stability, Postural StabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Keklicek, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772339
- Sponsor's protocol ID
- TÜTF-BAEK 2019/101
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effects of Foot Core Muscles Endurance and Fatigue Resistance of These Muscles on Postural Stability and Gait Stability in Different Conditions
- ClinicalTrials.gov ID
- NCT04772339
- Acronym / sponsor ID
- TÜTF-BAEK 2019/101
- Conditions
- Gait Stability, Postural Stability
- Keywords
- Foot Core Muscles, Balance, Fatigue, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Apr 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 26 Feb 2021 (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.
While walking, fatigue, sensorimotor function and motor control can affect in many ways. This research focuses on the relationship between foot core muscles with balance and gait parameters. The main purpose of the project is to investigate the effect of the endurance and fatigue responses of the extrinsic and intrinsic foot core muscles and the isolated fatigue response of the tibialis posterior muscle on balance and gait parameters.
Detailed description
The foot core system is responsible for the stability and dynamic and static function of the foot. Foot core muscles are part of the sub-systems that make up this system. Fatigue affects the basic characteristics of the sensorimotor system and impairs the accuracy of the voluntary movement. While walking, fatigue, sensorimotor function and motor control can affect in many ways. This research focuses on the relationship between foot core muscles with balance and gait parameters. The main purpose of the project is to investigate the effect of the endurance and fatigue responses of the extrinsic and intrinsic foot core muscles and the isolated fatigue response of the tibialis posterior muscle on balance and gait parameters.
The method of the project was established to investigate the effects of foot core muscles on balance and gait parameters. Demographic and basic physical characteristics of the participants (age, dominant hand, height, weight, education, marital status) will be taken and individuals with normal BMI will be included in the study. Each individual will walk on the treadmill for at least 512 steps at the rate he/she will have at his own pace. Then the individual will rest. Then the gait test on the 10% slope will be repeated and the individual will rest at the end of the test. The balance of individuals' will be evaluated with Y balance test after the resting process is ended. The Heel Rise test will be used to measure the endurance of the tibialis posterior muscle. The test will be repeated separately for both feet. Then the individual will be put on the gait and balance tests. The individual will be recalled the next day and the paper grip test will be performed to measure the total endurance of the foot core muscles. Then the individual will be put on the gait and balance tests.
With this research; the relationship between the endurance and fatigue responses of the foot core muscles, which have an important role in the protection and support of the foot arches and which perform this function with tonic contraction in daily life, will be determined. In this way, the results of the research will provide information to explain the gait cycle. We believe that with an original study we may support the development of rehabilitation processes for individuals who have gait problems or who are at risk of falling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | Other: Heel-Rise Test, Other: Paper Grip Test (PGT)Healthy adults aged between 18-30 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults aged between 18-30 within the normal BMI range by standards of WHO.
Key inclusion criteria (4 listed)
- Being in the age range of 18-30
- Being within the limits of body mass index (weight / height2: 18.5-24.9 kg / m2) accepted as normal BMI by the World Health Organization
- To have the ability to speak and understand Turkish
- Agree to participate in the study
Key exclusion criteria (7 listed)
- To be screened with any medical pre-diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
- Being monitored with any medical diagnosis (orthopedic, neurological, cardiovascular, psychiatric etc.)
- Taking medication during the research
- Having consumed alcohol in the past 48 hours
- Taking pain medication in the past 48 hours
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 |
|---|---|---|
| Heel-Rise TestThe Heel Rise test for endurance will be performed while the participant stands on a box with 10 ° inclination on one leg. Participants will be allowed to get support from the wall at the point at shoulder level with two fingertips in order to maintain balance. A metronome of 30 beats per minute will be used to maintain the heel-rise frequency every 2 seconds. The participant will be asked to rise as high as possible with each heel rise, then lower the heel to the starting position, and with the next warning, he/she will be asked again. The participant will be asked to adapt to the pace of the metronome as much as possible and to continue the test as much as possible. The test will be terminated when the participant stops, fails to maintain frequency, or performs a proper heel raise. The number of heel raises obtained at the end of the test will be used for data analysis. | Other | Healthy Adults |
| Paper Grip Test (PGT)In the paper grip test, a paper is placed under the individual's thumb and the person is asked to squeeze this paper strongly between the big toe and the ground. The paper is pulled by the person performing the test and the individual is asked to hold the paper with his/her thumb as much as he/she can. When the person applies the maximum force, the height of the medial longitudinal arch is measured with a digital caliper in millimeters. The time that the individual can maintain the MLA height with this maximum force is recorded with a stopwatch. | Other | Healthy Adults |
Primary outcome
Gait analysis
Time frame: It will be recorded at baseline, after the heel-rise test and after the paper-grip test
Gait will be evaluated by a sensor gait analysis system. Sensors of this system are attached to the shoes of the individual and do not touch the skin. Each individual will freely walk on the treadmill for a period of time to achieve at least 512 steps at his/her own pace. To find the preferred walking speed of the individual, we will use the Hinton et al. protocol (Hinton et al., 2018). After the speed is determined, the individual will be provided to practice walking at this speed for 4-5 minutes. Then the walk will continue until at least 512 steps required for gait analysis are collected. After reaching the sufficient number of steps, the individual will be asked to slow down and stop walking. Then the individual will be taken to rest. The rest period will be determined according to the preference of the individual. Then the gait test will be repeated on 10% inclined ground and at the end of the test, the individual will rest again.
Y Balance Test
Time frame: It will be recorded 5 minues after the gait analysis at baseline, after heel-rise test and after paper-grip test
In the test setup, 3 length gauges (tape measure) are fixed on the non-slip surface to make an angle of 120 degrees with each other. The participant will be asked to stand on one leg of his/her choice at the intersection of these 3 measuring tapes, and to reach out with his/her toe in 3 directions with the other foot: anterior, posteromedial, and posterolateral. In the meantime, attention will be paid to ensure that the participant does not lose his balance, the heel of the foot on which he is standing does not rise from the ground, and the toes of the extended foot are just slightly touching the ground. This application will be repeated 3 times for each direction, averaged and recorded in cm, and the total score will be determined by proportioning the individual's functional leg length (trochanter major and ground distance).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Stability, Postural Stability, run by Trakya University at 1 site in Turkey (Türkiye).
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 7 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 26 Feb 2021. 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 Turkey (Türkiye). 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?
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?
Gait analysis (time frame: It will be recorded at baseline, after the heel-rise test and after the paper-grip test). The study lists 2 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 26 Feb 2021.