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

November 16, 2019 updated by: Marius Molund, Oslo University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
52 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
52 weeks
Ankle range of motion
Time Frame: 52 weeks
Ankle dorsiflexion measured am Lindsjø
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 29, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

November 16, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 16, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUN studien

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no such plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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