NCT04168307

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

November 15, 2019

Last Update Submit

November 16, 2019

Conditions

Ankle Fracture - Lateral MalleolusPost-Op Complication

Keywords

ankle fracturerehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Visual analog scale for pain (VAS)

    52 weeks

  • Ankle range of motion

    52 weeks

Study Arms (2)

Ankle trainer device

EXPERIMENTAL

The patients were instructed in the use of a new spring loaded ankle trainer

Device: Ankle trainer device

Conventional physiotherapy

ACTIVE COMPARATOR

The patients were instructed in passive stretching exercises by the use of a non-elastic band

Other: Conventional physiotherapy

Interventions

Ankle trainer deviceDEVICE

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

Ankle trainer device
Conventional physiotherapyOTHER

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

Conventional physiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weber b ankle fracture. Exercise stable osteosynthesis. Good compliance

You may not qualify if:

  • Previous trauma to the tibia or fibula. Previous ankle or foot surgery. Sympthomatic arthritis or generalized joint disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle FracturesPostoperative Complications

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marius Molund, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The physiotherapist conducting follow ups at 6, 12 and 52 weeks was masked for group affiliation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

November 29, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

There is no such plan