Ankle Fracture - Lateral MalleolusNCT04168307
Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation.
A study testing Ankle trainer device and Conventional physiotherapy in people with Ankle Fracture - Lateral Malleolus and Post-Op Complication, run by Oslo University Hospital.
Trial summary
The study will compare the functions outcomes between two different rehabilitation protocol after operated weber b ankle fractures Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fracture - Lateral Malleolus, Post-Op Complication
- What is being tested?
- Ankle trainer device and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2014to 1 Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weber b ankle fracture. Exercise stable osteosynthesis. Good compliance
Who cannot join
- Previous trauma to the tibia or fibula. Previous ankle or foot surgery. Sympthomatic arthritis or generalized joint disease
About this study
Official title: Conventional Physiotherapy Versus Use of a New Ankle Trainer Device After Weber b Ankle Fracture Operation. A Randomized Controlled Trial
The study will compare the functions outcomes between two different rehabilitation protocol after operated weber b ankle fractures
Read the detailed description
Patients that are operated for weber b ankle fractures will after the surgery be randomized into two different post operative rehabilitation protocols. One group will receive conventional physiotherapy with stretching of the ankle with a non-elastic band, while the other group will use a new spring-loaded ankle trainer. The rehabilitation will continue for 3 weeks. Patients will be evaluated with the Olerud Molander ankle score and visual analog scale for pain at 3, 6, 12 and 52 weeks follow-up. Length of hospitalization and all adverse events will be registered. Ankle range of motion will be registered at 6, 12 and 52 weeks
- Being tested
- Ankle trainer device, Conventional physiotherapy
- Keywords
- ankle fracture, rehabilitation
- Medical subject headings
- Ankle Fractures, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle trainer deviceDevice
The ankle trainer provides passive stretch in dorsal flexion of the ankle as well as active plantar flexion.
Conventional physiotherapyOther
The patients were instructed in stretching exercises using a non-elastic band
| Study group | Role | What they receive |
|---|---|---|
| Ankle trainer device | Experimental | The patients were instructed in the use of a new spring loaded ankle trainer Receives: Device: Ankle trainer device |
| Conventional physiotherapy | Active comparator | The patients were instructed in passive stretching exercises by the use of a non-elastic band Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud Molander ankle score (OMAS)
A patient related outcome measure that evaluates ankle function on a 0-100 scale. 100 is indicating a perfect result
Measured: 52 weeks after surgery
Secondary outcomes (2)
Visual analog scale for pain (VAS)
Describes pain on a 0-10 scale with 0 representing no pain, and 10 the worst imaginable pain
Measured: 52 weeks
Ankle range of motion
Ankle dorsiflexion measured am Lindsjø
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start29 Nov 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Fracture - Lateral MalleolusStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Molund, Oslo University Hospital
- Investigators
- Marius Molund, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168307
- Sponsor's protocol ID
- FUN studien
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no such plan
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Physiotherapy Versus Use of a New Ankle Trainer Device After Weber b Ankle Fracture Operation. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04168307
- Acronym / sponsor ID
- FUN studien
- Keywords
- ankle fracture, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 19 Nov 2019 (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 study will compare the functions outcomes between two different rehabilitation protocol after operated weber b ankle fractures
Detailed description
Patients that are operated for weber b ankle fractures will after the surgery be randomized into two different post operative rehabilitation protocols. One group will receive conventional physiotherapy with stretching of the ankle with a non-elastic band, while the other group will use a new spring-loaded ankle trainer. The rehabilitation will continue for 3 weeks. Patients will be evaluated with the Olerud Molander ankle score and visual analog scale for pain at 3, 6, 12 and 52 weeks follow-up. Length of hospitalization and all adverse events will be registered. Ankle range of motion will be registered at 6, 12 and 52 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle trainer device | Experimental | Device: Ankle trainer deviceThe patients were instructed in the use of a new spring loaded ankle trainer |
| Conventional physiotherapy | Active comparator | Other: Conventional physiotherapyThe patients were instructed in passive stretching exercises by the use of a non-elastic band |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Weber b ankle fracture. Exercise stable osteosynthesis. Good compliance
Key exclusion criteria (1 listed)
- Previous trauma to the tibia or fibula. Previous ankle or foot surgery. Sympthomatic arthritis or generalized joint disease
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 trainer deviceThe ankle trainer provides passive stretch in dorsal flexion of the ankle as well as active plantar flexion. | Device | Ankle trainer device |
| Conventional physiotherapyThe patients were instructed in stretching exercises using a non-elastic band | Other | Conventional physiotherapy |
Primary outcome
Olerud Molander ankle score (OMAS)
Time frame: 52 weeks after surgery
A patient related outcome measure that evaluates ankle function on a 0-100 scale. 100 is indicating a perfect result
2 secondary outcomes
Visual analog scale for pain (VAS)
Time frame: 52 weeks
Ankle range of motion
Time frame: 52 weeks
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 19 Nov 2019.
- Individual participant dataSharing planned: No. There is no such plan
Related trials for Ankle Fracture - Lateral Malleolus
Active, not recruiting
Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures
Ankle Fractures, Posterior Malleolus Fractures
Recruiting
A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
Lateral Malleolus Fracture
Recruiting
Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures
Lateral Malleolus Fractures
Not yet recruiting
Plate Versus Intramedullary Screw for Lateral Malleolus Fracture in Ankle Fracture Type A&B
Fixation of Lateral Malleolus in Ankle Fracture Type A&B by Plate Versus Intramedullary Screw
Recruiting
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Ankle Fractures, Ankle Fracture - Lateral Malleolus
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.
Marius Molund, MD principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ankle trainer device and Conventional physiotherapy in people with Ankle Fracture - Lateral Malleolus and Post-Op Complication, run by Oslo University Hospital.
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 1 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Olerud Molander ankle score (OMAS) (time frame: 52 weeks after surgery). 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 19 Nov 2019.