HealthyNCT07009496
Effects of Muscle Fatigue
A study testing Tibialis Anterior Fatigue Protocol and Gastrocnemius Fatigue Protocol in people with Healthy and Fatigue, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- What is being tested?
- Tibialis Anterior Fatigue Protocol and Gastrocnemius Fatigue Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Does not meet the inclusion criteria
- History of trauma or surgery in the lower extremities
- Regular participation in exercise or being a professional athlete
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Beykent University Physiotherapy Lab.
Istanbul, Büyükçekmece
About this study
Official title: Investigation of the Effects of Muscle Fatigue in Healthy Young Adults
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.
Read the detailed description
Study Aim and Rationale This study aims to investigate the acute effects of fatigue in the tibialis anterior and gastrocnemius muscles on joint position sense, dynamic balance, muscle elasticity, and pain threshold in healthy young adults. Muscle fatigue is known to directly impact motor function and physical performance; therefore, understanding its influence on neuromuscular parameters such as proprioception, postural control, and biomechanical properties is crucial for developing effective clinical strategies. By evaluating how these specific muscle groups respond to fatigue, the study seeks to generate evidence that can guide physiotherapy and rehabilitation practices.
Methodology A total of 35 healthy adults aged 18-24 who meet the inclusion criteria will participate. All procedures will be conducted at the Physiotherapy and Rehabilitation Laboratory of Istanbul Beykent University. Dominant lower limbs, determined by the foot used in a spontaneous ball-kicking task, will be used for testing. Participants will first undergo a tibialis anterior fatigue protocol, followed one week later by a gastrocnemius fatigue protocol. Each participant will be assessed at four time points: before the fatigue protocol, immediately after, 24 hours later, and 48 hours later.
Participants will be instructed to refrain from high-intensity exercise, stretching, massage, hot/cold applications, and medications for 48 hours prior to testing. These instructions will be provided both verbally and in writing.
Fatigue will be induced through repeated isometric contractions (30 seconds contraction, 15 seconds rest). For tibialis anterior, participants will lie supine and perform dorsiflexion against resistance at a fixed 100° ankle angle using a customized apparatus. For gastrocnemius, participants will lie prone with feet hanging off the table and perform plantarflexion against a wall. Fatigue threshold will be defined as a score ≥7 on the Modified Borg Scale.
Assessments will include:
Joint Position Sense (JPS): Measured using active angle reproduction at 10° dorsiflexion and 20° plantarflexion. The DrGoniometer app will record angular error, and absolute error values will be computed.
Dynamic Balance: Assessed with the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions. Reach distances will be normalized to limb length, and composite scores will be calculated.
Muscle Elasticity: Evaluated using the MyotonPro device in multiscan mode with standardized settings. Measurements will be taken from the most prominent points of the tibialis anterior, medial gastrocnemius, and lateral gastrocnemius.
Pain Threshold: Measured using a pressure algometer device.
Fatigue Metrics: Captured with the ForceDecks dual force plate system (VALD Performance). The system will record jump height, concentric peak velocity, eccentric duration, braking phase duration, peak power, and RSI-mod index.
All assessments are non-invasive and conducted under standardized conditions. Rest periods will be provided between tests to prevent cumulative fatigue from affecting results.
Sample Size and Randomization Sample size was calculated using G*Power (α=0.05, power=95%) based on stiffness values of the medial gastrocnemius reported by Lall (2022). The required sample size was 29; to compensate for potential dropouts, 35 participants will be included. Simple randomization will be conducted from a list of 200 eligible individuals using randomizer.org.
- Being tested
- Tibialis Anterior Fatigue Protocol, Gastrocnemius Fatigue Protocol
- Keywords
- Exstrinsic Foot Muscle, Fatigue, Balance
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibialis Anterior Fatigue ProtocolBehavioural
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.
Gastrocnemius Fatigue ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Gastrocnemius Fatigue Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
Secondary outcomes (1)
Force Plate Fatigue Metrics
Performance and time-based measures collected via ForceDecks dual force plates, including jump height, peak power, RSI-mod, and contraction durations.
Measured: Baseline and immediately post-fatigue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Feb 2025
- Primary completion15 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şahbaz, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009496
- Sponsor's protocol ID
- UBeykent-14
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data (IPD) due to ethical considerations and institutional policies regarding participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Muscle Fatigue in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07009496
- Acronym / sponsor ID
- UBeykent-14
- Keywords
- Exstrinsic Foot Muscle, Fatigue, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Aim and Rationale This study aims to investigate the acute effects of fatigue in the tibialis anterior and gastrocnemius muscles on joint position sense, dynamic balance, muscle elasticity, and pain threshold in healthy young adults. Muscle fatigue is known to directly impact motor function and physical performance; therefore, understanding its influence on neuromuscular parameters such as proprioception, postural control, and biomechanical properties is crucial for developing effective clinical strategies. By evaluating how these specific muscle groups respond to fatigue, the study seeks to generate evidence that can guide physiotherapy and rehabilitation practices.
Methodology A total of 35 healthy adults aged 18-24 who meet the inclusion criteria will participate. All procedures will be conducted at the Physiotherapy and Rehabilitation Laboratory of Istanbul Beykent University. Dominant lower limbs, determined by the foot used in a spontaneous ball-kicking task, will be used for testing. Participants will first undergo a tibialis anterior fatigue protocol, followed one week later by a gastrocnemius fatigue protocol. Each participant will be assessed at four time points: before the fatigue protocol, immediately after, 24 hours later, and 48 hours later.
Participants will be instructed to refrain from high-intensity exercise, stretching, massage, hot/cold applications, and medications for 48 hours prior to testing. These instructions will be provided both verbally and in writing.
Fatigue will be induced through repeated isometric contractions (30 seconds contraction, 15 seconds rest). For tibialis anterior, participants will lie supine and perform dorsiflexion against resistance at a fixed 100° ankle angle using a customized apparatus. For gastrocnemius, participants will lie prone with feet hanging off the table and perform plantarflexion against a wall. Fatigue threshold will be defined as a score ≥7 on the Modified Borg Scale.
Assessments will include:
Joint Position Sense (JPS): Measured using active angle reproduction at 10° dorsiflexion and 20° plantarflexion. The DrGoniometer app will record angular error, and absolute error values will be computed.
Dynamic Balance: Assessed with the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions. Reach distances will be normalized to limb length, and composite scores will be calculated.
Muscle Elasticity: Evaluated using the MyotonPro device in multiscan mode with standardized settings. Measurements will be taken from the most prominent points of the tibialis anterior, medial gastrocnemius, and lateral gastrocnemius.
Pain Threshold: Measured using a pressure algometer device.
Fatigue Metrics: Captured with the ForceDecks dual force plate system (VALD Performance). The system will record jump height, concentric peak velocity, eccentric duration, braking phase duration, peak power, and RSI-mod index.
All assessments are non-invasive and conducted under standardized conditions. Rest periods will be provided between tests to prevent cumulative fatigue from affecting results.
Sample Size and Randomization Sample size was calculated using G*Power (α=0.05, power=95%) based on stiffness values of the medial gastrocnemius reported by Lall (2022). The required sample size was 29; to compensate for potential dropouts, 35 participants will be included. Simple randomization will be conducted from a list of 200 eligible individuals using randomizer.org.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibialis Anterior Fatigue Protocol | Experimental | Behavioral: Tibialis Anterior Fatigue ProtocolParticipants 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. |
| Gastrocnemius Fatigue Protocol | Experimental | Behavioral: Gastrocnemius Fatigue ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Does not meet the inclusion criteria
- History of trauma or surgery in the lower extremities
- Regular participation in exercise or being a professional athlete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibialis Anterior Fatigue ProtocolParticipants 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. | Behavioural | Tibialis Anterior Fatigue Protocol |
| Gastrocnemius Fatigue ProtocolParticipants 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. | Behavioural | Gastrocnemius Fatigue Protocol |
Primary outcome
Change in Joint Position Sense (JPS)
Time frame: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
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.
Change in Dynamic Balance Performance
Time frame: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
Normalized reach distance and composite score from the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions.
Change in Muscle Elasticity
Time frame: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue
Normalized reach distance and composite score from the Modified Star Excursion Balance Test (SEBT) in anterior, posteromedial, and posterolateral directions.
1 secondary outcome
Force Plate Fatigue Metrics
Time frame: Baseline and immediately post-fatigue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data (IPD) due to ethical considerations and institutional policies regarding participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibialis Anterior Fatigue Protocol and Gastrocnemius Fatigue Protocol in people with Healthy and Fatigue, run by University of Beykent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Joint Position Sense (JPS) (time frame: Baseline, immediately post-fatigue, 24 hours post-fatigue, 48 hours post-fatigue). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.