NCT06181071

Brief Summary

This is a study aiming to investigate the effects of acute muscle fatigue on muscle properties, balance and foot plantar pressure in healthy young adults (having no chronic diseases or orthopaedic diseases and physically active). This study also aims to compare the effects of foot muscle fatigue and hip muscle fatigue on balance and foot plantar pressure. The exercises for ankle muscle fatigue are heel rise with bending your knee and heel raise without bending your knees. The exercise for hip muscle fatigue is a single-leg squat. Before and after completing these all exercises, the balance is evaluated with an isokinetic balance device, the foot plantar pressure is evaluated with a pedobarography device and finally, the muscle properties are evaluated with a myotonPro device. All assessment devices are non-invasive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
Last Updated

August 22, 2025

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

December 11, 2023

Last Update Submit

August 18, 2025

Conditions

Keywords

muscular fatiguebalanceelasticitymuscle tonusfoot plantar pressure

Outcome Measures

Primary Outcomes (2)

  • Myotonometric Assesment

    Myotonometeric assessment is a non-invasive and novel method used to characterize the viscoelastic and biomechanical properties of muscles. The MyotonPro (Myoton Ltd, Myoton AS, Estonia) is an objective assessment tool that has been validated for inter-rater and intra-rater reliability, enabling the evaluation of mechanical and viscoelastic properties such as muscle tone, stiffness, and elasticity. The MyotonPro device is positioned perpendicular to the skin surface when the muscles are in a relaxed position. The device's probe applies an initial pressure of approximately 0.18 N to the skin surface, compressing the underlying tissue. Subsequently, a mechanical force of 0.4 N is applied for 15 ms to the compressed tissue beneath the skin.

    Day 1 and Day 8

  • Isokinetic Balance Assesment

    The TecnoBody Prokin PK 252 device, which is one of the objective methods used for the assessment of static and dynamic balance, allows the acquisition of numerical data at the end of the evaluation. Equipped with an isokinetic balance system, this device consists of a screen monitor and a sloped platform on which the individuals being evaluated stand. This platform has air pistons that provide a 15-degree tilt in all directions. These air pistons come into play, especially during the assessment of dynamic balance. The settings of the platform can be adjusted according to the evaluator's decision, thanks to the servo motors associated with the device.

    Day 1 and Day 8

Secondary Outcomes (1)

  • Foot Plantar Pressure Distribution Assesment

    Day 1 and Day 8

Study Arms (2)

Distal Fatigue of The Lower Extremity

OTHER

Distal muscle fatigue of the lower extremity involves the plantar and dorsiflexor muscles of the ankle.

Other: Distal Muscle Fatigue ProtocolOther: Proximal Muscle Fatigue Protocol

Proximal Fatigue of The Lower Extremity

OTHER

Proximal muscle fatigue of the lower extremity involves hip flexor and extansor muscles.

Other: Distal Muscle Fatigue ProtocolOther: Proximal Muscle Fatigue Protocol

Interventions

Initially, sociodemographic data, muscle viscoelastic properties, foot plantar pressure, and static and dynamic balance are assessed. Additionally, the strengths of the plantar flexor and dorsiflexor muscles are evaluated. After these assessments, the heel raise exercise will be implemented in this protocol. Firstly, dominant leg, the heel raise exercise will be performed for 3 sets with the knees in full extension until the individual reaches fatigue. Subsequently, the heel raise exercise will be conducted for another 3 sets with the knee in flexion until the individual reaches fatigue. Following these exercises, Then, the strengths of the hip flexor and extensor muscles will be re-evaluated. If the individual reports a value of 7 or higher on the modified Borg scale, the viscoelastic properties of the muscles, foot plantar pressure, and static and dynamic balance will be reassessed when a 50% decrease in the initial strength is detected.

Distal Fatigue of The Lower ExtremityProximal Fatigue of The Lower Extremity

One week after the application of the distal muscle fatigue protocol, the same individuals will undergo the proximal fatigue protocol. In this protocol, individuals will perform, dominant leg, a single-leg squat exercise targeting the fatigue of the hip flexor and extensor muscles. Prior to this exercise, the viscoelastic properties of the muscles, foot plantar pressure, static and dynamic balances, as well as the strengths of the hip flexor and extensor muscles will be assessed. Then, individuals will perform the single-leg squat exercise, 3 sets. When the individual indicates fatigue, the set will conclude, allowing a 30-second rest between sets. Then, the strengths of the hip flexor and extensor muscles will be re-evaluated. If the individual reports a value of 7 or higher on the modified Borg scale, the viscoelastic properties of the muscles, foot plantar pressure, and static and dynamic balance will be reassessed when a 50% decrease in the initial strength is detected.

Distal Fatigue of The Lower ExtremityProximal Fatigue of The Lower Extremity

Eligibility Criteria

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

You may qualify if:

  • To be a healthy individual in the age range of 18-35,
  • To be willing to participate in the study,
  • To have a minimal active or highly active score on the International Physical Activity Questionnaire (Short Form),
  • To have a body mass index (BMI) of 24.9 kg/m² or lower.

You may not qualify if:

  • Having a history of injury and/or surgical operation related to the lower extremity,
  • Having limited mobility in the lower extremity,
  • Having any deformity related to the lower extremity,
  • Having cardiovascular, vestibular, neurological, orthopedic, or skin-related diseases,
  • Having any chronic disease that may affect balance,
  • Having any acute/chronic musculoskeletal pain or systemic pain,
  • Not to have given consent to participate in the study or to wish to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Laboratory

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulenay Yildirim

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 26, 2023

Study Start

December 1, 2023

Primary Completion

January 10, 2024

Study Completion

January 18, 2024

Last Updated

August 22, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations