Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
70 participants
OBSERVATIONAL
2023-09-18
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to investigate if targeted physiotherapy for post-traumatic ankle conditions designed based of diagnostic ultrasonography findings is more effective than standard physiotherapy. The study hypothesis is that in the experimental group there will be a smaller number of complications of post-traumatic ankle conditions than in the control group. If confirmed the study could have clinical implications.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of the Most Commonly Used Physiotherapeutic Treatments for Acute Lower Limb Fatigue in Athletes
NCT05167162
Dynamic Ultrasound in Evaluation of Tendo-ligamentous Ankle Injury
NCT03621150
Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis
NCT05676632
Biomechanics and Intrinsic Foot Muscle Roles in Subjects With Chronic Ankle Instability
NCT05815576
Assessment of Accuracy of Ultrasonography in Diagnosis of Non-osseous Lateral Ankle Instability in Comparison With Magnetic Resonance Imaging
NCT04834479
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In a randomized controlled trial, patients with post-traumatic soft tissue damage in the ankle area will be randomly divided into two groups. Both groups will undergo the same number of physiotherapy sessions (10 half-hour outpatient sessions over the course of two months) and will be examined with standard clinical tests and diagnostic ultrasonography at the beginning of the program and at week 8 using a standardized protocol published by the European Society of Musculoskeletal Radiology. Both groups will undergo the same physiotherapy techniques. Their choice will be modified in the experimental group based on the current findings of diagnostic sonography, while in the control group they will be applied according to the standard procedure recommended by the physician.
Randomization
Participants meeting the entry criteria will be examined by diagnostic ultrasonography, then randomly assigned to two groups using software (https://www.randomizer.org/) and sent for an entry examination by an independent investigator. Group 1 will undergo standard physiotherapy without continuous monitoring of the course and effect of treatment with diagnostic ultrasonography. The treatment of the second group will be modified based on the current findings of the diagnostic ultrasonography. The therapeutic protocol for each patient will be given to an independent physiotherapist (the therapist will not know the details of the study) in a sealed envelope.
Study participants
Study participants will be recruited based on referrals from specialists (mainly orthopaedists or surgeons) following the entry and exclusion criteria below. When a patient meeting the criteria is detected, the specialist will offer the patient the opportunity to participate in the study, and if agreed, the patient will be sent to our workplace for an initial examination.
Sample size
A sample size of 26 patients per group (N=52) was estimated to test the difference in pain (primary outcome, scale 0-10; at 80% test power (Cohen´s d=0.8) and at the 0.05 significance level) between the intervention and control groups. We estimate that 15% of participants will not complete the study, therefore 68 patients will be enrolled in the study (34 patients in each group).
Basic statistical analysis of outcome variables
Difference in numeric variables (pain, chronic ankle instability rate, the 10 Metre Walk Test, examination of ankle dorsiflexion muscle strength) between the intervention and control groups will be tested using the two-sample t-test or Mann-Whitney Test, if normality of the data was not fulfilled. Data normality will be assessed using the Shapiro-Wilk test and visually using box and whisker plots, histograms and normal probability plots. Difference in categorical variables (the range of motion of the ankle, the presence of swelling, number of complications) will be tested using chi-square test or Fisher's exact test, if at least one expected frequency will be smaller than 5. R software will be used for analysis.
Examination
Demographic, anthropometric and anamnestic data of all participants will be recorded at the beginning of the programme (age, sex, height, weight, exercise history, injury history, including frequency of past injuries, footwear). The clinical examination will be carried out at the beginning and at the end of the therapeutic program, i.e. after two months from the start of the program.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard physiotherapy group
Patients will be treated with standard physiotherapy according to the recommendation of the referring physician without modification of the treatment based on the output of the diagnostic ultrasonography examination.
Diagnostic ultrasonography-guided physiotherapy group
All participants will complete free 10 outpatient 30-minute sessions. The therapy will be focused on increasing the range of motion and muscle strength, optimizing the function of the lower limbs, reducing possible complications of post-traumatic conditions in the ankle area.
The physiotherapy procedures of the intervention group will be modified based on the initial diagnostic ultrasonography examination.
Diagnostic ultrasonography-guided physiotherapy group
Patients will undergo modified treatment techniques, the application of which will be indicated based on the initial diagnostic ultrasonographic examination.
Diagnostic ultrasonography-guided physiotherapy group
All participants will complete free 10 outpatient 30-minute sessions. The therapy will be focused on increasing the range of motion and muscle strength, optimizing the function of the lower limbs, reducing possible complications of post-traumatic conditions in the ankle area.
The physiotherapy procedures of the intervention group will be modified based on the initial diagnostic ultrasonography examination.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Diagnostic ultrasonography-guided physiotherapy group
All participants will complete free 10 outpatient 30-minute sessions. The therapy will be focused on increasing the range of motion and muscle strength, optimizing the function of the lower limbs, reducing possible complications of post-traumatic conditions in the ankle area.
The physiotherapy procedures of the intervention group will be modified based on the initial diagnostic ultrasonography examination.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Post-traumatic conditions in the ankle area, 0 - 6 weeks after the primary injury
* Ability to undergo continuous outpatient physiotherapy treatment
* Active cooperation of the patient
Exclusion Criteria
* Serious diseases affecting effective physiotherapy (e.g. tissue damage of metabolic, degenerative, neurological or oncological origin)
* Previous ankle surgery
* Gypsum fixation
15 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Petr Routner
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Petr Routner
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Petr Routner, MSc.
Role: PRINCIPAL_INVESTIGATOR
Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague
Kamila Řasová, PT, PhD.
Role: STUDY_DIRECTOR
Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alafia-RHB
Prague, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Fernandez WG, Yard EE, Comstock RD. Epidemiology of lower extremity injuries among U.S. high school athletes. Acad Emerg Med. 2007 Jul;14(7):641-5. doi: 10.1197/j.aem.2007.03.1354. Epub 2007 May 18.
Bergman R, Shuman VL. Acute Ankle Sprain. 2025 Aug 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459212/
Martin B. Ankle sprain complications: MRI evaluation. Clin Podiatr Med Surg. 2008 Apr;25(2):203-47, vi. doi: 10.1016/j.cpm.2007.12.004.
Faltus J, Boggess B, Bruzga R. The use of diagnostic musculoskeletal ultrasound to document soft tissue treatment mobilization of a quadriceps femoris muscle tear: a case report. Int J Sports Phys Ther. 2012 Jun;7(3):342-9. No abstract available.
Innes S, Jackson J. Musculoskeletal ultrasound imaging - An exploration of physiotherapists' interests and use in practice. Musculoskelet Sci Pract. 2019 Dec;44:102068. doi: 10.1016/j.msksp.2019.102068. Epub 2019 Sep 30.
Sconfienza LM, Adriaensen M, Albano D, Alcala-Galiano A, Allen G, Aparisi Gomez MP, Aringhieri G, Bazzocchi A, Beggs I, Chianca V, Corazza A, Dalili D, De Dea M, Del Cura JL, Di Pietto F, Drakonaki E, Facal de Castro F, Filippiadis D, Gitto S, Grainger AJ, Greenwood S, Gupta H, Isaac A, Ivanoski S, Khanna M, Klauser A, Mansour R, Martin S, Mascarenhas V, Mauri G, McCarthy C, McKean D, McNally E, Melaki K, Messina C, Miron Mombiela R, Moutinho R, Olchowy C, Orlandi D, Prada Gonzalez R, Prakash M, Posadzy M, Rutkauskas S, Snoj Z, Tagliafico AS, Talaska A, Tomas X, Vasilevska Nikodinovska V, Vucetic J, Wilson D, Zaottini F, Zappia M, Obradov M. Clinical indications for image-guided interventional procedures in the musculoskeletal system: a Delphi-based consensus paper from the European Society of Musculoskeletal Radiology (ESSR)-part VI, foot and ankle. Eur Radiol. 2022 Feb;32(2):1384-1394. doi: 10.1007/s00330-021-08125-z. Epub 2021 Aug 25.
HEROLD, I. Hodnocení bolesti a kvality analgezie u kriticky nemocných na JIP. Anesteziologie a Intenzivni Medicina. 2013; 24(6): 430-433. ISSN 12142158.
PAZ, JC, QUINLAN, D. Acute Pain Management. Acute Care Handbook for Physical Therapists-E-Book. 2013; 7: 457-465.
WATSON CP, BOLAND RA., REFSHAUGE KM. Measurement reliability of swelling in the acute ankle sprain. The Foot & Ankle Journal. 2008; 1(12): 4.
Esterson PS. Measurement of ankle joint swelling using a figure of 8*. J Orthop Sports Phys Ther. 1979;1(1):51-2. doi: 10.2519/jospt.1979.1.1.51.
Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
Sisto SA, Dyson-Hudson T. Dynamometry testing in spinal cord injury. J Rehabil Res Dev. 2007;44(1):123-36. doi: 10.1682/jrrd.2005.11.0172.
Yin Y, Yu Z, Wang J, Sun J. Effectiveness of the Rehabilitation Training Combined with Maitland Mobilization for the Treatment of Chronic Ankle Instability: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Nov 20;19(22):15328. doi: 10.3390/ijerph192215328.
MCNALLY, E. Practical musculoskeletal ultrasound E-Book [online]. 2nd Edition. Churchill Livingstone, 2014. ISBN 978-1-4557-7404-3.
SCHMITZ, Marc J.H. Musculoskeletal ultrasound of the extremity joints : technical scanning guidelines [online]. SonoSkills, 2022. ISBN 9083240304.
BEGGS, Ian, STEFANO BIANCHI, ANGEL BUENO, MICHEL COHEN, MICHEL COURT-PAYEN, ANDREW GRAINGER, FRANZ KAINBERGER, ANDREA KLAUSER, CARLO MARTINOLI, EUGENE MCNALLY, J PHILIPO, PHILIPPE PEETRONS, MONIQUE REIJNIERSE. European Society of MusculoSkeletal Radiology Musculoskeletal Ultrasound Technical Guidelines VI. Ankle [online]. 2016 [cit. 2023-03-08]. Available at: https://essr.org/content-essr/uploads/2016/10/ankle.pdf
Petersen EJ, Irish SM, Lyons CL, Miklaski SF, Bryan JM, Henderson NE, Masullo LN. Reliability of water volumetry and the figure of eight method on subjects with ankle joint swelling. J Orthop Sports Phys Ther. 1999 Oct;29(10):609-15. doi: 10.2519/jospt.1999.29.10.609.
Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.
R CORE TEAM. R Core Team 2021 R: A language and environment for statistical computing. R foundation for statistical computing. https://www.R-project.org/. R Foundation for Statistical Computing [online]. 2022, 2, 2019 [cit. 2023-01-30]. Available at: https://www.scirp.org/(S(czeh2tfqw2orz553k1w0r45))/reference/referencespapers.aspx?referenceid=3131254
De Maeseneer M, Marcelis S, Jager T, Shahabpour M, Van Roy P, Weaver J, Jacobson JA. Sonography of the normal ankle: a target approach using skeletal reference points. AJR Am J Roentgenol. 2009 Feb;192(2):487-95. doi: 10.2214/AJR.08.1316.
Bandinelli S, Benvenuti E, Del Lungo I, Baccini M, Benvenuti F, Di Iorio A, Ferrucci L. Measuring muscular strength of the lower limbs by hand-held dynamometer: a standard protocol. Aging (Milano). 1999 Oct;11(5):287-93. doi: 10.1007/BF03339802.
Related Links
Access external resources that provide additional context or updates about the study.
CORE MEASURE: 10 METER WALK TEST (10mWT)
Gait Range of Motion Animation
microFET2 User Guide
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
81512267
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.