Ankle InjuriesNCT04586036
The Evaluation of Ankle Joint Braces Efficiency
A study testing ankle joint brace 1, ankle joint brace 2 and ankle joint brace 3 in people with Ankle Injuries and Ankle Sprains, run by Barbara Łysoń at 1 site in Poland.
Trial summary
The project concerns the evaluation of commercially available ankle joint braces effectiveness used as orthopedic supply after ankle joint ligaments tear injury. Authors hypothesize that the restriction of range of motion may be not sufficient in the early healing process. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries, Ankle Sprains
- What is being tested?
- ankle joint brace 1, ankle joint brace 2 and ankle joint brace 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 20 Jan 2020
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-35
- female or male
- good health condition
- chronic ankle joint instability (for chronic ankle instability group)
Who cannot join
- lower limb injuries (last 6 months)
- extreme sports athletes
- no chronic ankle joint instability (for chronic ankle instability group)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Józef Piłsudski University of Physical Education in Warsaw
Warsaw, Mazowsze, 00-968
About this study
The project concerns the evaluation of commercially available ankle joint braces effectiveness used as orthopedic supply after ankle joint ligaments tear injury. Authors hypothesize that the restriction of range of motion may be not sufficient in the early healing process.
- Conditions
- Ankle Injuries, Ankle Sprains
- Being tested
- ankle joint brace 1, ankle joint brace 2, ankle joint brace 3, ankle joint brace 4, ankle joint brace 5
- Keywords
- ankle joint brace, atfl, oxford foot model
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle joint brace 1Other
The influence of ankle joint brace 1 on gait biomechanics
ankle joint brace 2Other
The influence of ankle joint brace 2 on gait biomechanics
ankle joint brace 3Other
The influence of ankle joint brace 3 on gait biomechanics
ankle joint brace 4Other
The influence of ankle joint brace 4 on gait biomechanics
ankle joint brace 5Other
The influence of ankle joint brace 5 on gait biomechanics
| Study group | Role | What they receive |
|---|---|---|
| young healthy adults | Experimental | Gait measured by Vicon Nexus System Receives: Other: ankle joint brace 1; Other: ankle joint brace 2; Other: ankle joint brace 3; Other: ankle joint brace 4; Other: ankle joint brace 5 |
| young adults with chronic ankle joint instability | Experimental | Gait measured by Vicon Nexus System Receives: Other: ankle joint brace 1; Other: ankle joint brace 2; Other: ankle joint brace 3; Other: ankle joint brace 4; Other: ankle joint brace 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Foot Model Angles
Ankle angles, Hindfoot Tibia angles and Forefoot Hindfoot angles caculated by Oxford Foot Model, colected with the use of Vicon Motion Capture system
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Łysoń
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Barbara Łysoń, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586036
- Sponsor's protocol ID
- DS-295
- Status last verified
- Feb 2021
- First submitted
- 8 Oct 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Ankle Joint Braces Efficiency
- ClinicalTrials.gov ID
- NCT04586036
- Acronym / sponsor ID
- DS-295
- Conditions
- Ankle Injuries, Ankle Sprains
- Keywords
- ankle joint brace, atfl, oxford foot model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Barbara ŁysońUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 14 Oct 2020 (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.
The project concerns the evaluation of commercially available ankle joint braces effectiveness used as orthopedic supply after ankle joint ligaments tear injury. Authors hypothesize that the restriction of range of motion may be not sufficient in the early healing process.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young healthy adults | Experimental | Other: ankle joint brace 1, Other: ankle joint brace 2, Other: ankle joint brace 3, Other: ankle joint brace 4, Other: ankle joint brace 5Gait measured by Vicon Nexus System |
| young adults with chronic ankle joint instability | Experimental | Other: ankle joint brace 1, Other: ankle joint brace 2, Other: ankle joint brace 3, Other: ankle joint brace 4, Other: ankle joint brace 5Gait measured by Vicon Nexus System |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-35
- female or male
- good health condition
- chronic ankle joint instability (for chronic ankle instability group)
Key exclusion criteria (3 listed)
- lower limb injuries (last 6 months)
- extreme sports athletes
- no chronic ankle joint instability (for chronic ankle instability group)
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 |
|---|---|---|
| ankle joint brace 1The influence of ankle joint brace 1 on gait biomechanics | Other | young adults with chronic ankle joint instability, young healthy adults |
| ankle joint brace 2The influence of ankle joint brace 2 on gait biomechanics | Other | young adults with chronic ankle joint instability, young healthy adults |
| ankle joint brace 3The influence of ankle joint brace 3 on gait biomechanics | Other | young adults with chronic ankle joint instability, young healthy adults |
| ankle joint brace 4The influence of ankle joint brace 4 on gait biomechanics | Other | young adults with chronic ankle joint instability, young healthy adults |
| ankle joint brace 5The influence of ankle joint brace 5 on gait biomechanics | Other | young adults with chronic ankle joint instability, young healthy adults |
Primary outcome
Oxford Foot Model Angles
Time frame: 2 hours
Ankle angles, Hindfoot Tibia angles and Forefoot Hindfoot angles caculated by Oxford Foot Model, colected with the use of Vicon Motion Capture system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ankle joint brace 1, ankle joint brace 2 and ankle joint brace 3 in people with Ankle Injuries and Ankle Sprains, run by Barbara Łysoń at 1 site in Poland.
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 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: finished, as of the sponsor's last update on 3 Mar 2021. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Foot Model Angles (time frame: 2 hours). 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 3 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.