Tibialis Posterior Fatigue and Plantar Pressure

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT04415099

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

65.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Muscle Fatigue	Other: Muscle fatigue protocol	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 2020

Actual Primary Completion Date :

Jul 15, 2020

Actual Study Completion Date :

Jul 15, 2020

Arms and Interventions

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: Unilateral heel raise exercise Close chain resisted foot adduction exercise

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: Unilateral heel raise exercise Close chain resisted foot adduction exercise

Outcome Measures

Primary Outcome Measures

Peak Plantar Pressures of the foot [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

Contact area of the foot [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pınar Kısacık	Ankara		Turkey

Sponsors and Collaborators

Hacettepe University

Investigators

Study Director: Nilgün Bek, Prof.Dr., Lokman Hekim Üniversitesi
Principal Investigator: Azize Reda Caferoglu Tunç, MSc, Lokman Hekim Üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pınar Kısacık, PhD, Research Assistant, PhD., Hacettepe University

ClinicalTrials.gov Identifier:

NCT04415099

Other Study ID Numbers:

LUT 12/46-16

First Posted:

Jun 4, 2020

Last Update Posted:

Jul 20, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pınar Kısacık, PhD, Research Assistant, PhD., Hacettepe University

Plantar pressure distribution

muscle fatigue

tibialis posterior

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Jul 20, 2020