Healthy AdolescentsNCT07161531
Test-retest Reliability of sEMG to Measure Fatigue in Adolescents
A study testing Surface Electromyography in people with Healthy Adolescents, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
This cross-sectional study aims to determine the test-retest reliability of surface electromyography (sEMG) outcomes in detecting levels of fatigue among healthy adolescents engaged in physical activities. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adolescents
- What is being tested?
- Surface Electromyography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Mar 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- engage in regular physical activity, such as sports or dance
Who cannot join
- neuromuscular disorders
- conditions that affect muscle function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universiteit Antwerpen, Department of Rehabilitation Sciences and Physiotherapy, Research group MOVANT
Wilrijk, 2610
Ann Hallemans, PhD, 032652912, ann.hallemans@uantwerpen.be
About this study
Official title: Evaluating Test-Retest Reliability of Surface Electromyography (sEMG) in Measuring Fatigue in Adolescents Through Prolonged Activity
This cross-sectional study aims to determine the test-retest reliability of surface electromyography (sEMG) outcomes in detecting levels of fatigue among healthy adolescents engaged in physical activities. It seeks to evaluate the consistency of sEMG parameters across two test sessions and correlate these measurements with both performance metrics and subjective fatigue assessments.
Participants will perform repetitive squatting until volitional exhaustion while their muscular activity is recorded. They will do so on two different test sessions with an interval of one week in between.
- Conditions
- Healthy Adolescents
- Being tested
- Surface Electromyography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface ElectromyographyDiagnostic test
The primary lower limb muscles to be monitored include the gluteus medius, rectus femoris, vastus lateralis (quadriceps ), biceps femoris (hamstrings), tibialis anterior, and gastrocnemius medialis (calves). This setup fully utilizes a 16-channel sEMG system by monitoring each muscle group bilaterally to capture comprehensive data on muscle activity and fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue | Experimental | To induce muscular fatigue, participants will perform a repetitive bodyweight squat until 1) the squat cannot be performed over the full range of motion for 2 consecutive repetitions and 2) physical exertion occurs (10-point Borg scale). Receives: Diagnostic Test: Surface Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
sEMG median power frequency (MPF) - test
A parameter used to analyze the frequency content of the electrical signals generated by muscle activity. Changes in the MPF can indicate alterations in muscle fiber recruitment and metabolic changes during sustained muscle contractions
Measured: first test session at day 1
sEMG median power frequency - retest
A parameter used to analyze the frequency content of the electrical signals generated by muscle activity. Changes in the MPF can indicate alterations in muscle fiber recruitment and metabolic changes during sustained muscle contractions
Measured: second test session after 1 week
sEMG RMS amplitude - test
A single value that represents the magnitude of the sEMG signal over a specified period of time, higher RMS values indicate greater muscle activation.
Measured: first test session at day 1
sEMG RMS amplitude - retest
A single value that represents the magnitude of the sEMG signal over a specified period of time, higher RMS values indicate greater muscle activation.
Measured: second test session after 1 week
Secondary outcomes (2)
VAS score - test
subjective fatigue score
Measured: first test session at day 1
VAS score - retest
subjective fatigue score
Measured: second session after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start12 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy AdolescentsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Hallemans, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161531
- Sponsor's protocol ID
- 6979
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mokkink, L.B., de Vet, H., Diemeer, S. et al. Sample size recommendations for studies on reliability and measurement error: an online application based on simulation studies. Health Serv Outcomes Res Method 23, 241-265 (2023)
Patikas DA, Williams CA, Ratel S. Exercise-induced fatigue in young people: advances and future perspectives. Eur J Appl Physiol. 2018 May;118(5):899-910. doi: 10.1007/s00421-018-3823-1. Epub 2018 Feb 13.
PubMed 29441401Lynn SK, Watkins CM, Wong MA, Balfany K, Feeney DF. Validity and Reliability of Surface Electromyography Measurements from a Wearable Athlete Performance System. J Sports Sci Med. 2018 May 14;17(2):205-215. eCollection 2018 Jun.
PubMed 29769821Cifrek M, Medved V, Tonkovic S, Ostojic S. Surface EMG based muscle fatigue evaluation in biomechanics. Clin Biomech (Bristol). 2009 May;24(4):327-40. doi: 10.1016/j.clinbiomech.2009.01.010. Epub 2009 Mar 13.
PubMed 19285766
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Test-Retest Reliability of Surface Electromyography (sEMG) in Measuring Fatigue in Adolescents Through Prolonged Activity
- ClinicalTrials.gov ID
- NCT07161531
- Acronym / sponsor ID
- 6979
- Conditions
- Healthy Adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Sep 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 cross-sectional study aims to determine the test-retest reliability of surface electromyography (sEMG) outcomes in detecting levels of fatigue among healthy adolescents engaged in physical activities. It seeks to evaluate the consistency of sEMG parameters across two test sessions and correlate these measurements with both performance metrics and subjective fatigue assessments.
Participants will perform repetitive squatting until volitional exhaustion while their muscular activity is recorded. They will do so on two different test sessions with an interval of one week in between.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatigue | Experimental | Diagnostic Test: Surface ElectromyographyTo induce muscular fatigue, participants will perform a repetitive bodyweight squat until 1) the squat cannot be performed over the full range of motion for 2 consecutive repetitions and 2) physical exertion occurs (10-point Borg scale). |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- engage in regular physical activity, such as sports or dance
Key exclusion criteria (2 listed)
- neuromuscular disorders
- conditions that affect muscle function
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 |
|---|---|---|
| Surface ElectromyographyThe primary lower limb muscles to be monitored include the gluteus medius, rectus femoris, vastus lateralis (quadriceps ), biceps femoris (hamstrings), tibialis anterior, and gastrocnemius medialis (calves). This setup fully utilizes a 16-channel sEMG system by monitoring each muscle group bilaterally to capture comprehensive data on muscle activity and fatigue. | Diagnostic test | Fatigue |
Primary outcome
sEMG median power frequency (MPF) - test
Time frame: first test session at day 1
A parameter used to analyze the frequency content of the electrical signals generated by muscle activity. Changes in the MPF can indicate alterations in muscle fiber recruitment and metabolic changes during sustained muscle contractions
sEMG median power frequency - retest
Time frame: second test session after 1 week
A parameter used to analyze the frequency content of the electrical signals generated by muscle activity. Changes in the MPF can indicate alterations in muscle fiber recruitment and metabolic changes during sustained muscle contractions
sEMG RMS amplitude - test
Time frame: first test session at day 1
A single value that represents the magnitude of the sEMG signal over a specified period of time, higher RMS values indicate greater muscle activation.
sEMG RMS amplitude - retest
Time frame: second test session after 1 week
A single value that represents the magnitude of the sEMG signal over a specified period of time, higher RMS values indicate greater muscle activation.
2 secondary outcomes
VAS score - test
Time frame: first test session at day 1
VAS score - retest
Time frame: second session after 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- BackgroundMokkink, L.B., de Vet, H., Diemeer, S. et al. Sample size recommendations for studies on reliability and measurement error: an online application based on simulation studies. Health Serv Outcomes Res Method 23, 241-265 (2023)
- Background: PubMed 29441401Patikas DA, Williams CA, Ratel S. Exercise-induced fatigue in young people: advances and future perspectives. Eur J Appl Physiol. 2018 May;118(5):899-910. doi: 10.1007/s00421-018-3823-1. Epub 2018 Feb 13.
- Background: PubMed 29769821Lynn SK, Watkins CM, Wong MA, Balfany K, Feeney DF. Validity and Reliability of Surface Electromyography Measurements from a Wearable Athlete Performance System. J Sports Sci Med. 2018 May 14;17(2):205-215. eCollection 2018 Jun.
- Background: PubMed 19285766Cifrek M, Medved V, Tonkovic S, Ostojic S. Surface EMG based muscle fatigue evaluation in biomechanics. Clin Biomech (Bristol). 2009 May;24(4):327-40. doi: 10.1016/j.clinbiomech.2009.01.010. Epub 2009 Mar 13.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Electromyography in people with Healthy Adolescents, run by Universiteit Antwerpen at 1 site in Belgium.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Sep 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Hallemans, Associate Professor, PhD (+3232652912, ann.hallemans@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sEMG median power frequency (MPF) - test (time frame: first test session at day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07161531, which also lists 4 linked publications.
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 8 Sep 2025.