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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

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.

Condition or disease Intervention/treatment Phase
Muscle Fatigue Other: Muscle fatigue protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Effect of Tibialis Posterior Muscle Fatigue on Plantar Pressure Characteristics
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Foot Health

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415099


Locations
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Turkey
Pınar Kısacık
Ankara, Turkey
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Nilgün Bek, Prof.Dr. Lokman Hekim Üniversitesi
Principal Investigator: Azize Reda Caferoglu Tunç, MSc Lokman Hekim Üniversitesi
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Responsible Party: Pınar Kısacık, PhD, Research Assistant, PhD., Hacettepe University
ClinicalTrials.gov Identifier: NCT04415099    
Other Study ID Numbers: LUT 12/46-16
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pınar Kısacık, PhD, Hacettepe University:
Plantar pressure distribution
muscle fatigue
tibialis posterior
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms