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Tibialis Posterior Fatigue and Plantar Pressure

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ClinicalTrials.gov Identifier: NCT04415099
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pınar Kısacık, PhD, Hacettepe University

Tracking Information
First Submitted Date  ICMJE April 14, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date July 20, 2020
Actual Study Start Date  ICMJE July 1, 2020
Actual Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tibialis Posterior Fatigue and Plantar Pressure
Official Title  ICMJE The Effect of Tibialis Posterior Muscle Fatigue on Plantar Pressure Characteristics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Muscle Fatigue
Intervention  ICMJE Other: Muscle fatigue protocol

Tibialis posterior was fatigued using 2 exercises:

  1. Unilateral heel raise exercise
  2. Close chain resisted foot adduction exercise
Study Arms  ICMJE Experimental: One group
Only one group was assessed before and after performing muscle fatigue protocol.
Intervention: Other: Muscle fatigue protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2020
Actual Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04415099
Other Study ID Numbers  ICMJE LUT 12/46-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pınar Kısacık, PhD, Hacettepe University
Study Sponsor  ICMJE Hacettepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nilgün Bek, Prof.Dr. Lokman Hekim Üniversitesi
Principal Investigator: Azize Reda Caferoglu Tunç, MSc Lokman Hekim Üniversitesi
PRS Account Hacettepe University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP