NCT07009496

Brief Summary

This study aims to investigate the acute effects of fatigue in the tibialis anterior and gastrocnemius muscles on joint position sense, balance, pain threshold, and muscle elasticity in healthy young adults. Muscle fatigue is known to directly affect physical performance and motor function; therefore, understanding its influence on neuromuscular parameters such as proprioception, postural control, and tissue properties is of great importance. By examining how these specific muscle groups respond to fatigue, the study seeks to clarify the role of fatigue in altering joint position sense, balance performance, pain perception, and muscle mechanical properties. The findings of this research are expected to provide new insights that may contribute to the development of more effective strategies in physical therapy and rehabilitation practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2025

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

February 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 29, 2025

Last Update Submit

May 29, 2025

Conditions

Keywords

Exstrinsic Foot MuscleFatigueBalance

Outcome Measures

Primary Outcomes (3)

  • Change in Joint Position Sense (JPS)

    Absolute error (in degrees) in ankle joint position sense measured using the active angle reproduction method with the DrGoniometer app. bsolute error (in degrees) in ankle joint position sense measured using the active angle reproduction method with the DrGoniometer app. bsolute error (in degrees) in ankle joint position sense measured using the active angle reproduction method with the DrGoniometer app.

    Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue

  • Change in Dynamic Balance Performance

    Normalized reach distance and composite score from the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions.

    Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue

  • Change in Muscle Elasticity

    Normalized reach distance and composite score from the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions.

    Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue

Secondary Outcomes (1)

  • Force Plate Fatigue Metrics

    Baseline and immediately post-fatigue

Study Arms (2)

Tibialis Anterior Fatigue Protocol

EXPERIMENTAL

Participants perform isometric dorsiflexion exercises targeting the tibialis anterior muscle in a supine position using a custom-designed apparatus fixed at 100° ankle dorsiflexion. The fatigue protocol includes 30-second contraction and 15-second rest cycles, repeated until a score of ≥7 is reached on the Modified Borg Scale. Neuromuscular assessments-including joint position sense, dynamic balance, muscle elasticity, pain threshold, and fatigue metrics-are conducted at four time points: before, immediately after, 24 hours, and 48 hours post-protocol.

Behavioral: Tibialis Anterior Fatigue Protocol

Gastrocnemius Fatigue Protocol

EXPERIMENTAL

Participants perform isometric plantarflexion exercises targeting the gastrocnemius muscle while in a prone position with the foot pressing against a wall. The protocol consists of repeated 30-second contractions and 15-second rest cycles until a Modified Borg Scale score of ≥7 is reported. Evaluations of joint position sense, balance, muscle elasticity, pain threshold, and performance-based fatigue metrics are conducted at the same time intervals: before, immediately after, 24 hours, and 48 hours following the protocol.

Behavioral: Gastrocnemius Fatigue Protocol

Interventions

Participants lie in a supine position with the ankle fixed at 100° dorsiflexion using a custom apparatus. They perform repeated isometric dorsiflexion contractions for 30 seconds followed by 15 seconds of rest. The protocol continues until a perceived exertion of ≥7 is reported on the Modified Borg Scale. Evaluations include joint position sense, balance, muscle elasticity, pain threshold, and performance metrics recorded at four time points: pre-, post-, 24h, and 48h.

Tibialis Anterior Fatigue Protocol

Participants lie in a prone position with their foot placed against a wall. They perform repeated isometric plantarflexion contractions for 30 seconds with 15 seconds of rest between repetitions. The exercise is continued until a Modified Borg score of ≥7 is reached. Measurements of neuromuscular and biomechanical parameters are conducted at the same four time points: before, immediately after, 24 hours, and 48 hours post-exercise.

Gastrocnemius Fatigue Protocol

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 24 years
  • Body Mass Index (BMI) between 18.5 and 24.9
  • Low to moderate physical activity level
  • No history of neurological or orthopedic disorders
  • Full range of motion in the ankle joint
  • Voluntary participation and informed consent provided

You may not qualify if:

  • History of trauma or surgery in the lower extremities
  • Regular participation in exercise or being a professional athlete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Beykent University Physiotherapy Lab.

Istanbul, Büyükçekmece, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 6, 2025

Study Start

February 1, 2025

Primary Completion

April 15, 2025

Study Completion

May 20, 2025

Last Updated

June 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

This study does not plan to share individual participant data (IPD) due to ethical considerations and institutional policies regarding participant confidentiality.

Locations