NCT04415099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

July 20, 2020

Status Verified

May 1, 2020

Enrollment Period

14 days

First QC Date

April 14, 2020

Last Update Submit

July 17, 2020

Conditions

Keywords

Plantar pressure distributionmuscle fatiguetibialis posterior

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (4)

  • Contact area of the foot

    1 month

  • Foot axis angle

    1 month

  • Subtalar angle

    1 month

  • Static plantar pressure

    1 month

Study Arms (1)

One group

EXPERIMENTAL

Only one group was assessed before and after performing muscle fatigue protocol.

Other: Muscle fatigue protocol

Interventions

Tibialis posterior was fatigued using 2 exercises: 1. Unilateral heel raise exercise 2. Close chain resisted foot adduction exercise

One group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants were excluded from this study if they had any orthopedic or neurological disorder, need to use an assistive device or orthoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pınar Kısacık

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Nilgün Bek, Prof.Dr.

    Lokman Hekim University

    STUDY DIRECTOR
  • Azize Reda Caferoglu Tunç, MSc

    Lokman Hekim University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD.

Study Record Dates

First Submitted

April 14, 2020

First Posted

June 4, 2020

Study Start

July 1, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

July 20, 2020

Record last verified: 2020-05

Locations