- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415099
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
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
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: One group
Only one group was assessed before and after performing muscle fatigue protocol.
|
Tibialis posterior was fatigued using 2 exercises:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
July 1, 2020
Primary Completion (Actual)
July 15, 2020
Study Completion (Actual)
July 15, 2020
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
May 30, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2020
Last Update Submitted That Met QC Criteria
July 17, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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