Acute Ankle SprainPhase 2NCT01586390
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast
A Phase 2 study testing Functional treatment for ankle sprain using ankle cast and Ankle sprain treated with removable ankle support in people with Acute Ankle Sprain and Ankle Ligament Rupture, run by Spaarne Gasthuis at 1 site in Netherlands.
Trial summary
In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials. Follow-up was 4 months. Primary outcome were functional scores. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Ankle Sprain, Ankle Ligament Rupture, Ankle Injuries
- What is being tested?
- Functional treatment for ankle sprain using ankle cast and Ankle sprain treated with removable ankle support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 2 and 3 acute ankle sprains
Who cannot join
- history of ankle sprains with persistent instability
- grade I lateral ankle sprains
- ankle fracture
- bilateral ankle sprains
- previous ankle ligament surgery
- neuromuscular disorders of the lower extremities
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- rheumatoid arthritis,
- alcoholism,
- serious psychiatric or neurological illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial
In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials.
Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.
- Conditions
- Acute Ankle Sprain, Ankle Ligament Rupture, Ankle Injuries
- Being tested
- Functional treatment for ankle sprain using ankle cast, Ankle sprain treated with removable ankle support
- Keywords
- Ankle Sprain, Ankle Distortion, Functional treatment, Brace treatment
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional treatment for ankle sprain using ankle castOther
Functional treatment for ankle sprain using ankle cast
Ankle sprain treated with removable ankle supportOther
Ankle sprain functionally treated with removable and adjustable ankle support
| Study group | Role | What they receive |
|---|---|---|
| MOK | Experimental | Adjustable and removable brace made out of Softcast material Receives: Other: Ankle sprain treated with removable ankle support |
| WRAP | Active comparator | Softcast ankle cast Receives: Other: Functional treatment for ankle sprain using ankle cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional scores according to Karlsson score
The modified KSS gives a score from 0-90 on perceived function of the ankle and foot, divided over eight topics relevant to daily function. The modified KSS at 4 months was the primary endpoint.
Measured: Follow-up of 4 months
Secondary outcomes (2)
Pain
Measured by Visual analogue scale (1-10)
Measured: follow-up of 4 months
Satisfaction score
satisfaction scores with treatment as well as treatment result on scale 1-10
Measured: follow-up of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ankle SprainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Mensch, Spaarne Gasthuis
- Investigators
- Daniel Mensch, MD, Principal investigator, Spaarne Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586390
- Sponsor's protocol ID
- WRAPvsMOK
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial
- ClinicalTrials.gov ID
- NCT01586390
- Acronym / sponsor ID
- WRAPvsMOK
- Conditions
- Acute Ankle Sprain, Ankle Ligament Rupture, Ankle Injuries
- Keywords
- Ankle Sprain, Ankle Distortion, Functional treatment, Brace treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Apr 2012 (estimated)
- 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.
In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials.
Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOK | Experimental | Other: Ankle sprain treated with removable ankle supportAdjustable and removable brace made out of Softcast material |
| WRAP | Active comparator | Other: Functional treatment for ankle sprain using ankle castSoftcast ankle cast |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Grade 2 and 3 acute ankle sprains
Key exclusion criteria (9 listed)
- history of ankle sprains with persistent instability
- grade I lateral ankle sprains
- ankle fracture
- bilateral ankle sprains
- previous ankle ligament surgery
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 |
|---|---|---|
| Functional treatment for ankle sprain using ankle castFunctional treatment for ankle sprain using ankle cast | Other | WRAP |
| Ankle sprain treated with removable ankle supportAnkle sprain functionally treated with removable and adjustable ankle support | Other | MOK |
Primary outcome
Functional scores according to Karlsson score
Time frame: Follow-up of 4 months
The modified KSS gives a score from 0-90 on perceived function of the ankle and foot, divided over eight topics relevant to daily function. The modified KSS at 4 months was the primary endpoint.
2 secondary outcomes
Pain
Time frame: follow-up of 4 months
Satisfaction score
Time frame: follow-up of 4 months
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 26 Apr 2012.
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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.
Daniel Mensch, MD principal investigator
Spaarne Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Functional treatment for ankle sprain using ankle cast and Ankle sprain treated with removable ankle support in people with Acute Ankle Sprain and Ankle Ligament Rupture, run by Spaarne Gasthuis at 1 site in Netherlands.
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 1 inclusion and 9 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 26 Apr 2012. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional scores according to Karlsson score (time frame: Follow-up of 4 months). 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 26 Apr 2012.