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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04168307
Other study ID # FUN studien
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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