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

Not Applicable

Completed

• Conditions: Post-Op Complication; Ankle Fracture - Lateral Malleolus
• Interventions: Device: Ankle trainer device; Other: Conventional physiotherapy

• Registration Number: NCT04168307
• Lead Sponsor: Oslo University Hospital

Brief Summary

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 Timeline

• Study Start: 2014-11-29
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-16
• Last Update Submitted: 2019-11-16
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ankle trainer device	Ankle trainer device	The patients were instructed in the use of a new spring loaded ankle trainer
Conventional physiotherapy	Conventional physiotherapy	The patients were instructed in passive stretching exercises by the use of a non-elastic band

Primary Outcome Measures

Name	Time	Method
Olerud Molander ankle score (OMAS)	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 Outcome Measures

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