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Ankle SprainsSonograPHYNCT05916300

Diagnostic Ultrasonography in Physiotherapy

An observational study of Ankle Sprains and Ankle Injuries, run by Petr Routner at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Ankle injuries are among the most common traumatological injuries of the lower limb accounting for approximately 50% of all sports injuries and 25% of musculoskeletal injuries in general. Read more about this study

Who is it for?
Ages 15 to 65 years
Conditions the study is for
Ankle Sprains, Ankle Injuries, Ankle Edema
What is being tested?
Diagnostic ultrasonography-guided physiotherapy group
How many people
70 participants
Where
1 siteCzechia
Study dates
18 Sep 2023to Dec 2025
Phase
Observational
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 15 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with acute post-traumatic ankle conditions

Who may be able to join

  • Age ≥ 15 years and ≤ 65 years
  • 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

Who cannot join

  • Age < 15 years and > 65 years
  • Serious diseases affecting effective physiotherapy (e.g. tissue damage of metabolic, degenerative, neurological or oncological origin)
  • Previous ankle surgery
  • Gypsum fixation

Trial locations and contacts

1 site in 1 country.

Petr Routner, MSc. contact

+420602393203

routa2005@seznam.cz

Czechia1 site, 1 recruiting

  • Alafia-RHB

    Prague, 19800

    Petr Routner, MSc., +420602393203, routa2005@seznam.cz

    Kamila Řasová, PT, PhD., +420604511416, kamila.rasova@gmail.com

    Recruiting

Other trials in Czechia

About this study

Official title: Diagnostic Ultrasonography in Physiotherapy as a Prevention of the Development of Complications of Post-Traumatic Ankle Conditions

Ankle injuries are among the most common traumatological injuries of the lower limb accounting for approximately 50% of all sports injuries and 25% of musculoskeletal injuries in general. Correct initial diagnosis and proper management is important to reduce the risk of recurrent ankle instability and other complications, such as reduced range of motion, increased ligament laxity, instability, tendon enthesopathy, possible swelling, formation of calcifications, reduced load on the affected limbs while standing and walking, increased pain intensity and pain duration. To date, few studies showed that the effectiveness of physical therapy increases when it is modified based on diagnostic ultrasonography findings. Sonography is not burdensome for the patient, has high reproducibility, and enables dynamic examination and comparison of the interrelationships of individual structures.

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.

Read the detailed description

A randomized controlled trial

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.

Being tested
Diagnostic ultrasonography-guided physiotherapy group
Keywords
Diagnostic ultrasonography, physiotherapy, post-traumatic ankle conditions, prevention
Medical subject headings
Ankle Injuries, Ankle Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic ultrasonography-guided physiotherapy groupOther

    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.

Study groups in NCT05916300
Study groupRoleWhat they receive
Standard physiotherapy groupPatients 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.
Receives: Other: Diagnostic ultrasonography-guided physiotherapy group
Diagnostic ultrasonography-guided physiotherapy groupPatients will undergo modified treatment techniques, the application of which will be indicated based on the initial diagnostic ultrasonographic examination.
Receives: Other: Diagnostic ultrasonography-guided physiotherapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain level

    Examination using the Wong-Baker scale. The scale is used to subjectively assess pain. Pain rating scale (0-10): 0 - no pain; 2 - hurts a little; 4 - hurts a little more; 6 - hurts even more; 8 - hurts a lot; 10 - hurts the most (0 is the best value, 10 is the worst).

    Measured: The change from baseline to 8 weeks

  2. The range of motion of the ankle

    Goniometry will be performed with a stainless steel two-arm goniometer (ref. SH5103).

    Measurement of the ankle (talocrural joint) dorsiflexion range of motion: Participants will actively adduct the tip of the injured ankle while sitting on a physical therapy table. The expected range of motion with knee extension is approx. 10 degrees, with 20 degrees of knee flexion. For the evaluation, we will use a 3-point evaluation scale: 0-3 (0 - no limitation in dorsiflexion, 1 - small limitation in dorsiflexion, 2 - great limitation in dorsiflexion, 3 - no movement in dorsiflexion) (0 means the best value, 3 is the worst).

    Measured: The change from baseline to 8 weeks

  3. The measurement of swelling

    Over the course of the therapy, we will measure the swelling with a standard retractable four-inch plastic tape measure and a marking pen according to a standardized protocol. (decreasing the size of edema over time marks positive change).

    Measured: The change from baseline to 8 weeks

  4. Number of complications

    The following complications will be monitored using sonographic examination based on a standardized protocol issued by the European Society of Musculoskeletal Radiology using a 7L4BP 5-10 MHz linear probe.

    The following complications will be measured according to standardized methodologies and evaluated by comparison with the same measured parameters on the ankle of the uninjured leg: 1. greater thickness of the ligaments (anterior tibiofibular and anterior talofibular ligament); 2. the presence of exudate in the area of anterior talofibular ligament, 3. the presence of calcifications, 4. a reduction in the continuity of the ligament apparatus in the ankle or the continuity of the syndesmosis compared to the non-affected leg. A higher number means a higher number of complications.

    Measured: The change from baseline to 8 weeks

Secondary outcomes (3)

  1. Chronic ankle instability rate

    The Cumberland Ankle Instability Tool (CAIT) is a simple, valid and reliable instrument for discriminating and measuring the severity of functional ankle instability. The CAIT comprises a 9-item 30-point scale questionnaire (the higher final score indicates less severe functional ankle instability). Subjects with a score of 28 or higher are unlikely to have functional ankle instability, whereas subjects with a score of 27 or lower are likely to have functional ankle instability.

    Measured: The change from baseline to 8 weeks

  2. Analysis of standing and walking

    The 10 Metre Walk Test. We will measure the gait speed, using a stopwatch and markers, a phone with a camera (the lower value means better result).

    Measured: The change from baseline to 8 weeks

  3. Examination of ankle dorsiflexion muscle strength

    The examination will be held using a microFET2 hand-held digital dynamometer (Hoggan Scientific, USA).

    The examination will be held according to a standardized protocol: Subjects will lie supine with the knee extended and ankle of the tested leg in a neutral position on the bed. Ankle dorsiflexion will be tested by placing a dynamometer over the dorsal surface of the midfoot, just proximal to the metatarsal phalangeal joints. We will measure the isometric muscle strength (in N) when the patient tries for maximum resistance against the dynamometer of the affected ankle for four seconds. A higher value of muscle strength after rehabilitation means an improvement of the condition.

    Measured: The change from baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start18 Sep 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916300
Sponsor's protocol ID
81512267
Acronym
SonograPHY
Status last verified
Sep 2023
First submitted
26 Apr 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data sharing terms and conditions and the nature of the relationship between the study and new user will be contained in a Data-sharing Agreement that will be issued and signed before any data are handed out. The de-identification process for each patient is to ensure anonymization of individual patient's data, in order to be able to share IPD within the terms of participant's consent and ethics committee approval. The study policy on sharing defines the terms of privileged use by the study team. The research team requires to be appropriately notified and acknowledged in publications and other outputs of the transferred data (or analyses conducted by the study on the new users' behalf). The Data-sharing agreement will comprehend arrangements for data destruction or secure archiving. It is planned that the data will be placed into an online repository (to be specified later).

Publications

  • 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.

    PubMed 17513688

  • Bergman R, Li D, Shuman VL. Acute Ankle Sprain. 2025 Aug 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459212/

    PubMed 29083595

  • 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.

    PubMed 18346591

  • 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.

    PubMed 22666649

  • 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.

    PubMed 31585403

  • 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.

    PubMed 34432122

  • 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.

    PubMed 18810189

  • 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.

    PubMed 16935061

  • 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.

    PubMed 17551866

  • 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.

    PubMed 36430049

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Ankle Sprains and Ankle Injuries, run by Petr Routner at 1 site in Czechia.

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 Czechia. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Petr Routner, MSc. (+420602393203, routa2005@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain level (time frame: The change from baseline to 8 weeks). 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 NCT05916300, which also lists 21 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 21 Sep 2023.

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