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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04168307

Enrollment

113

Registered

2019-11-19

Start date

2014-11-29

Completion date

2017-12-01

Last updated

2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fracture - Lateral Malleolus, Post-Op Complication

Keywords

ankle fracture, rehabilitation

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

Interventions

DEVICEAnkle trainer device

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

OTHERConventional physiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

The physiotherapist conducting follow ups at 6, 12 and 52 weeks was masked for group affiliation

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Ankle range of motion	52 weeks	Ankle dorsiflexion measured am Lindsjø

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026