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

Post-Op Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04168307
• Other study ID #: FUN studien
• Status: Completed
• Phase: N/A
• Start date: November 29, 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: November 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture - Lateral Malleolus
• Ankle Fractures
• Fractures, Bone
• Post-Op Complication
• Postoperative Complications

Intervention

Device:
• Ankle trainer device
The ankle trainer provides passive stretch in dorsal flexion of the ankle as well as active plantar flexion.

Other:
• Conventional physiotherapy
The patients were instructed in stretching exercises using a non-elastic band

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Ankle range of motion	Ankle dorsiflexion measured am Lindsjø	52 weeks