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Completed

NCT Number: NCT04168307

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

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

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Key information

Conditions

Ankle Fracture - Lateral Malleolus Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Postoperative Complications Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle trainer device

Device

The ankle trainer provides passive stretch in dorsal flexion of the ankle as well as active plantar flexion.

Conventional Physiotherapy

Other

The patients were instructed in stretching exercises using a non-elastic band

Primary outcomes

  1. 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

Secondary outcomes

  1. Visual analog scale for pain (VAS)

    Time frame: 52 weeks

    Describes pain on a 0-10 scale with 0 representing no pain, and 10 the worst imaginable pain

  2. Ankle range of motion

    Time frame: 52 weeks

    Ankle dorsiflexion measured am Lindsjø

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 19, 2019
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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