Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation.

Study Overview
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Brief Summary
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The study will compare the functions outcomes between two different rehabilitation protocol after operated weber b ankle fractures

Detailed Description
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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

Official Title
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Conventional Physiotherapy Versus Use of a New Ankle Trainer Device After Weber b Ankle Fracture Operation. A Randomized Controlled Trial

Conditions
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Ankle Fracture - Lateral Malleolus, Post-Op Complication

Intervention / Treatment
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* Device: Ankle trainer device
* Other: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weber b ankle fracture. Exercise stable osteosynthesis. Good compliance Exclusion Criteria: Previous trauma to the tibia or fibula. Previous ankle or foot surgery. Sympthomatic arthritis or generalized joint disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ankle trainer device<br>The patients were instructed in the use of a new spring loaded ankle trainer | Device: Ankle trainer device<br>* The ankle trainer provides passive stretch in dorsal flexion of the ankle as well as active plantar flexion.<br>|
| Active Comparator: Conventional physiotherapy<br>The patients were instructed in passive stretching exercises by the use of a non-elastic band | Other: Conventional physiotherapy<br>* The patients were instructed in stretching exercises using a non-elastic band<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 52 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale for pain (VAS) | Describes pain on a 0-10 scale with 0 representing no pain, and 10 the worst imaginable pain | 52 weeks | 
| Ankle range of motion | Ankle dorsiflexion measured am Lindsjø | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle fracture, rehabilitation