Tibialis Posterior Fatigue and Plantar Pressure

July 17, 2020 updated by: Pınar Kısacık, PhD, Hacettepe University

The Effect of Tibialis Posterior Muscle Fatigue on Plantar Pressure Characteristics

The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to find out the changes in the measurable parameters of the dynamic and static position of the foot, caused by the tibialis posterior muscle which is activated by the fatigue protocol. The study includes 30 healthy patients whose socio-demographic and descriptive characteristics are held. The changes in the dynamic and static position of foot were measured by pedobarography whereas the level of fatigue was measured by Borg Fatigue Scale. The variables were investigated using Shapiro-Wilk's test to determine the normality. The student's t-test for paired samples were used to analyse, means (X), standard deviations (SD), 95% confidence intervals (95%CI), mean difference and Cohen's d-effect size were calculated. The significance level was set at .05. The effect size was considered 'small' if d= .20; 'medium' if .d=.5; 'large' if d= .8.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Pınar Kısacık

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All participants were currently free from congenital or traumatic deformity to either lower extremity,
  • A history of foot pain,
  • Prior history of surgery to the foot and lower extremity
  • A traumatic injury to the ankle or foot 12 months prior to the start of data collection.

Exclusion Criteria:

  • Participants were excluded from this study if they had any orthopedic or neurological disorder, need to use an assistive device or orthoses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One group
Only one group was assessed before and after performing muscle fatigue protocol.
Other: Muscle fatigue protocol

Tibialis posterior was fatigued using 2 exercises:

  1. Unilateral heel raise exercise
  2. Close chain resisted foot adduction exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak Plantar Pressures of the foot
Time Frame: 1 month
The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contact area of the foot
Time Frame: 1 month
The percentage of the contact area (CA%) of forefoot (FF), midfoot (MF) and hindfoot (HF) was recorded. The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
1 month
Foot axis angle
Time Frame: 1 month
Foot axis angle (FAA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
1 month
Subtalar angle
Time Frame: 1 month
Minimum and maximum value of the subtalar angle (STA) was recorded in unit of degree (o). The right foot of each subjects was chosen to be analysed to maintain independence of data. In line with this, all tests' first and third trials were exculeded from statistical analysis, because of avoiding acclimatization and boredom or tiredness.
1 month
Static plantar pressure
Time Frame: 1 month
The plantar pressure profiles were divided into 10 anatomical regions by using software support. These regions corresponded to followings : hallux (toe1), toes 2-5, first to fifth metatarsals (Meta1, Meta2, Meta3, Meta4, and Meta5), mid foot (MF), medial heel (MH), and lateral heel (LH). Peak pressure (PP, Newton-N) was analysed for all regions separately.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nilgün Bek, Prof.Dr., Lokman Hekim Üniversitesi
  • Principal Investigator: Azize Reda Caferoglu Tunç, MSc, Lokman Hekim Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUT 12/46-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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