Studying how muscles, ligaments and connective tissues around the knee work in healthy people using vibration testing, body composition analysis and muscle activity sensors
| ISRCTN | ISRCTN63017711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63017711 |
| Sponsor | Wroclaw Medical University |
| Funder | Uniwersytet Medyczny im. Piastów Slaskich we Wroclawiu |
- Submission date
- 10/10/2025
- Registration date
- 06/03/2026
- Last edited
- 06/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Understanding the biomechanical properties of myo-ligamentous-fascial structures is crucial in both the prevention and diagnosis of musculoskeletal disorders, as well as in optimizing therapy in physiotherapy and sports medicine. Increasing importance is being attributed to objective, quantitative methods for muscle assessment, which not only allow monitoring rehabilitation outcomes but also enable detection of subtle preclinical dysfunctions. The primary objective of this study is an interdisciplinary approach to the evaluation of muscles and fascial structures, integrating three independent diagnostic methods (myotonometry, sEMG, and BIA) within a unified research procedure.
Who can participate?
Healthy volunteers aged 20 to 24 years without musculoskeletal disorders or injuries, no implanted electronic devices such as pacemakers, and not pregnant in the case of female participants.
What does the study involve?
The study will be prospective, observational, and non-invasive. Each participant will undergo a single research session during which demographic data will be collected and non-invasive physiological, biomechanical, and bioelectrical measurements will be performed. The entire procedure will take approximately 20–25 minutes. The study will be conducted during one individual visit per participant and will include the following stages: interview and demographic-clinical data collection, body composition analysis (bioimpedance – Tanita), biomechanical properties assessment (myotonometry – MyotonPRO), and bioelectrical activity recording (sEMG).
What are the possible benefits and risks of participating?
The study does not provide direct therapeutic benefits and is of a cognitive and diagnostic-scientific nature. However, participants may gain indirect benefits such as receiving individualized information about the biomechanical properties of soft tissues and body composition, increasing awareness of their musculoskeletal health, and utilizing this information for prevention, lifestyle, or physiotherapeutic/medical consultations. Participation does not pose significant burden or health risk; all procedures are safe, brief, painless, and do not cause tissue damage or adverse effects. The project meets criteria for low-risk research with a high level of safety.
Where is the study run from?
Wroclaw Medical University (Poland)
When is the study starting and how long is it expected to run for?
June 2025 to December 2025
Who is funding the study?
Wroclaw Medical University (Poland)
Who is the main contact?
Weronika Bajer, weronika.bajer@umw.edu.pl
Contact information
Public, Scientific, Principal investigator
University Center of Physiotherapy and Rehabilitation
Wroclaw Medical University, 3 T.
Chałubińskiego Street
Wrocław
50-368
Poland
 ORCID ID |
0000-0003-4957-5385 |
|---|---|
| Phone | +48 (0)71/784 28 15 |
| weronika.bajer@umw.edu.pl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional study |
| Secondary study design | Cross sectional study |
| Scientific title | Assessment of the repeatability and agreement of myotonometry in measuring the biomechanical properties of myofascial–ligamentous structures: comparison with muscle bioelectrical activity and bioimpedance in the knee region – a prospective observational study (MYOFLEX) |
| Study acronym | MYOFLEX |
| Study objectives | Primary specific objectives: 1. To assess the intra-rater reliability of biomechanical property measurements of selected myo-ligamentous-fascial structures around the knee joint using myotonometry. 2. To compare the values obtained from myotonometric measurements with the bioelectrical activity (sEMG) of the muscles studied. 3. To compare biomechanical property measurements of the structures obtained by myotonometry with the results of bioimpedance analysis of the corresponding tissues. Secondary specific objectives: 1. To investigate the relationships between biomechanical properties, bioelectrical activity, and bioimpedance parameters within the myo-ligamentous-fascial tissues of the knee in healthy subjects. 2. To evaluate the influence of selected individual factors such as anthropometric characteristics (e.g., body mass, height, BMI), history of previous injuries, musculoskeletal disorders, and physical activity level assessed by the IPAQ questionnaire on the results of biomechanical property measurements of myo-ligamentous-fascial structures obtained by myotonometry. Hypotheses: H1: Myotonometry provides high reliability (ICC > 0.80) of biomechanical property measurements for all assessed structures within the knee, including muscles, ligaments, and fasciae. H2: There is a significant correlation between myotonometry results and the level of bioelectrical activity (sEMG) in the quadriceps femoris, adductor, and tensor fasciae latae muscles. H3: Biomechanical measurements obtained by myotonometry are significantly consistent with bioimpedance analysis results for periarticular soft tissues of the knee. H4: Biomechanical properties assessed by myotonometry correlate with bioelectrical activity and bioimpedance parameters, enabling a comprehensive functional characterization of the myo-ligamentous-fascial structures.H5: The biomechanical parameters of myo-ligamentous-fascial structures assessed by myotonometry differ significantly depending on anthropometric characteristics, medical history, history of injuries, and the level of physical activity declared in the IPAQ questionnaire. |
| Ethics approval(s) |
Approved 11/06/2025, Komisja Bioetyki Uniwersytetu Medycznego we Wrocławiu (50-367 Wrocław, ul. J. Mikulicza-Radeckiego 4a, Wrocław, 50-367, Poland; +48 (0)71 784 10 14; bioetyka@umw.edu.pl), ref: KB 203/2025 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | The planned study is exploratory in nature and focuses on the non-invasive assessment of biomechanical, bioelectrical, and bioimpedance properties of myo-ligamentous-fascial structures in the region of the knee joint in young adults. The rationale for conducting this project stems from the need to expand knowledge regarding the reliability and utility of modern functional diagnostic methods (myotonometry), which remain insufficiently studied in terms of their concordance with other techniques such as surface electromyography (sEMG) and bioimpedance analysis (BIA). The innovative character of the study lies in the comprehensive and simultaneous application of three assessment methods — MyotonPRO, EMG, and BIA — allowing not only analysis of measurement repeatability but also determination of relationships between physiological parameters, bioelectrical activity, and mechanical properties of soft tissues. Scientific literature lacks studies integrating these three diagnostic methods in a single protocol, particularly in the context of a healthy young adult population. The experiment is designed as a single-session, safe, short-duration, and non-invasive procedure. The required equipment and consumables are available at the University Center for Physiotherapy and Rehabilitation. The research team possesses appropriate experience and qualifications in deploying the methods used (myotonometry, sEMG, bioimpedance), ensuring the validity of procedural execution. The planned sample size (110 participants) is based on prior statistical analyses (G*Power) and data from systematic reviews concerning myotonometry. In the study, the demographic and clinical interview, along with the assessment of physical activity level using the short form of the International Physical Activity Questionnaire (IPAQ), will be conducted after obtaining informed consent from each participant. Subsequently, body composition will be analyzed via bioimpedance using the Tanita method. The next step will be the evaluation of biomechanical properties of the myo-ligamentous-fascial structures around the knee using the MyotonPRO device. Lastly, the bioelectrical muscle activity will be recorded through surface electromyography (sEMG). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Body mass, fat mass (kg and %), muscle mass (kg), hydration status (%), other relevant indices measured using bioelectrical impedance with Tanita analyzer at a single measurement during the study visit (baseline) |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 24 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Key inclusion criteria | 1. Age between 20 and 24 years 2. Informed and voluntary consent to participate confirmed by signing a consent form 3. No serious cardiovascular or respiratory diseases in acute phase 4. No implanted electrical devices such as pacemakers or defibrillators 5. No acute musculoskeletal injuries |
| Key exclusion criteria | 1. Lack of consent to participate in the study 2. Age outside the range of 20–24 years 3. Severe musculoskeletal 4. Infections or exacerbation of chronic diseases 5. Recent muscle injury at measurement site 6. Implanted pacemaker or other active electronic device 7. Pregnancy in women 8. Extensive skin lesions preventing attachment of EMG electrodes 9. Inability to cooperate |
| Date of first enrolment | 11/06/2025 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Poland
Study participating centre
Wrocław
50-368
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request from Dr Wojciech T Laber, Wroclaw Medical University, weronika.bajer@umw.edu.pl. Type of data to be shared: De-identified individual participant data (IPD) including baseline demographics, gait parameters, functional assessment scores, and quality-of-life measures. Timing of availability: Data will be available beginning 12 months after study completion and for at least 5 years thereafter. Consent: Written informed consent for participation has been obtained from all participants. Additional consent for data sharing is included in the patient information sheet. Data anonymization: All data will be fully de-identified prior to sharing; no names, dates of birth, or identifying information will be included. Ethical or legal restrictions: Data will only be shared in anonymized form and in accordance with applicable data protection regulations (GDPR). Additional comments: Access to data will be provided upon reasonable request to the corresponding author and after approval of a data-sharing agreement. |
Editorial Notes
14/10/2025: Trial's existence confirmed by Komisja Bioetyki Uniwersytetu Medycznego we Wrocławiu.
