Ankle Sprain 1St DegreeNCT06645262
First-degree Ankle Sprains
An observational study of Ankle Sprain 1St Degree, run by Rehabilitation Centre Zivot at 1 site in Bosnia and Herzegovina.
Trial summary
Grade I ankle sprains are common, especially among athletes, women, teenagers, and physically active individuals. While over a million cases are reported annually, this represents only half of the total occurrences. These injuries can lead to complications like chronic ankle instability or osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 weeks and older
- Conditions the study is for
- Ankle Sprain 1St Degree
- What is being tested?
- Cryotherapy
- How many people
- 100 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 12 Jun 2024to 1 Dec 2024
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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 18 weeks and older
- All sexes
- Child, Adult, Older adult
Study population: The sample is a convenience sample and will include individuals diagnosed with Grade I acute ankle sprain who present for examination at the specified institutions. After a proper diagnosis, confirmation of inclusion in the study, and signed ethical consent for participation in the research, randomization of participants will be conducted using an electronic number generator on the website www.randomizer.org/form:htm.
Who may be able to join
- Individuals diagnosed with Grade I acute ankle sprain confirmed by a specialist physician in radiology,
- Age of participants ≥ 18 years,
- Individuals of both sexes
Who cannot join
- Recurrent ankle injury,
- Acute ankle sprains of Grade II and III,
- Presence of other physical and/or mental health issues.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
Rehabilitation Centre Život
Mostar, 88000
Darko Bilić, mag.fizio., +38763318139, darkobilic@gmail.com
About this study
Grade I ankle sprains are common, especially among athletes, women, teenagers, and physically active individuals. While over a million cases are reported annually, this represents only half of the total occurrences. These injuries can lead to complications like chronic ankle instability or osteoarthritis. Treatment often involves conservative methods, including the PRICEMMS protocol (protection, rest, ice, compression, elevation, modalities, medication, and support), while surgery is reserved for severe cases. Therapeutic exercises and rehabilitation play a key role in recovery. The Bowen technique, effective for other musculoskeletal issues, has not yet been extensively studied for Grade I ankle sprains.
- Conditions
- Ankle Sprain 1St Degree
- Being tested
- Cryotherapy
- Keywords
- ankle sprain, Bowen technique
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
Also called cryotheraphy, braces, Bowen technique
cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | In this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique. Receives: Other: Cryotherapy | |
| Control Group | In this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and manual massage. Receives: Other: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of pain intensity
Measured on a numerical scale ranging from 0 to 10
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start12 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Sprain 1St DegreeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Rehabilitation Centre Zivot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darko Bilic, Rehabilitation Centre Zivot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645262
- Sponsor's protocol ID
- A2024
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-degree Ankle Sprains
- ClinicalTrials.gov ID
- NCT06645262
- Acronym / sponsor ID
- A2024
- Conditions
- Ankle Sprain 1St Degree
- Keywords
- ankle sprain, Bowen technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rehabilitation Centre ZivotUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Oct 2024 (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.
Grade I ankle sprains are common, especially among athletes, women, teenagers, and physically active individuals. While over a million cases are reported annually, this represents only half of the total occurrences. These injuries can lead to complications like chronic ankle instability or osteoarthritis. Treatment often involves conservative methods, including the PRICEMMS protocol (protection, rest, ice, compression, elevation, modalities, medication, and support), while surgery is reserved for severe cases. Therapeutic exercises and rehabilitation play a key role in recovery. The Bowen technique, effective for other musculoskeletal issues, has not yet been extensively studied for Grade I ankle sprains.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Other: CryotherapyIn this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and the Bowen technique. |
| Control Group | – | Other: CryotherapyIn this group, the intervention will consist of cryotherapy, therapeutic exercises, the use of braces, and manual massage. |
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The sample is a convenience sample and will include individuals diagnosed with Grade I acute ankle sprain who present for examination at the specified institutions. After a proper diagnosis, confirmation of inclusion in the study, and signed ethical consent for participation in the research, randomization of participants will be conducted using an electronic number generator on the website www.randomizer.org/form:htm.
Key inclusion criteria (3 listed)
- Individuals diagnosed with Grade I acute ankle sprain confirmed by a specialist physician in radiology,
- Age of participants ≥ 18 years,
- Individuals of both sexes
Key exclusion criteria (3 listed)
- Recurrent ankle injury,
- Acute ankle sprains of Grade II and III,
- Presence of other physical and/or mental health issues.
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 |
|---|---|---|
| CryotherapyAlso: cryotheraphy, braces, Bowen techniquecryotherapy, therapeutic exercises, the use of braces, and the Bowen technique. | Other | Control Group, Experimental Group |
Primary outcome
Subjective assessment of pain intensity
Time frame: 3 weeks
Measured on a numerical scale ranging from 0 to 10
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 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Ankle Sprain 1St Degree, run by Rehabilitation Centre Zivot at 1 site in Bosnia and Herzegovina.
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 3 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: looking for participants now, as of the sponsor's last update on 16 Oct 2024. 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 Bosnia and Herzegovina. 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 Darko Bilić, mag.fizio. (+38763318139, darkobilic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective assessment of pain intensity (time frame: 3 weeks). 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 16 Oct 2024.