Tibialis Posterior Fatigue and Plantar Pressure
Primary Purpose
Muscle Fatigue
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Muscle fatigue protocol
Sponsored by
About this trial
This is an interventional screening trial for Muscle Fatigue focused on measuring Plantar pressure distribution, muscle fatigue, tibialis posterior
Eligibility Criteria
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.
Sites / Locations
- Pınar Kısacık
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One group
Arm Description
Only one group was assessed before and after performing muscle fatigue protocol.
Outcomes
Primary Outcome Measures
Peak Plantar Pressures of the foot
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.
Secondary Outcome Measures
Contact area of the foot
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.
Foot axis angle
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.
Subtalar angle
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.
Static plantar pressure
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04415099
Brief Title
Tibialis Posterior Fatigue and Plantar Pressure
Official Title
The Effect of Tibialis Posterior Muscle Fatigue on Plantar Pressure Characteristics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Fatigue
Keywords
Plantar pressure distribution, muscle fatigue, tibialis posterior
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One group
Arm Type
Experimental
Arm Description
Only one group was assessed before and after performing muscle fatigue protocol.
Intervention Type
Other
Intervention Name(s)
Muscle fatigue protocol
Intervention Description
Tibialis posterior was fatigued using 2 exercises:
Unilateral heel raise exercise
Close chain resisted foot adduction exercise
Primary Outcome Measure Information:
Title
Peak Plantar Pressures of the foot
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Contact area of the foot
Description
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.
Time Frame
1 month
Title
Foot axis angle
Description
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.
Time Frame
1 month
Title
Subtalar angle
Description
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.
Time Frame
1 month
Title
Static plantar pressure
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilgün Bek, Prof.Dr.
Organizational Affiliation
Lokman Hekim Üniversitesi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Azize Reda Caferoglu Tunç, MSc
Organizational Affiliation
Lokman Hekim Üniversitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pınar Kısacık
City
Ankara
Country
Turkey
12. IPD Sharing Statement
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Tibialis Posterior Fatigue and Plantar Pressure
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