Back to resultsPhysiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation.
Primary Purpose
Ankle Fracture - Lateral Malleolus, Post-Op Complication
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ankle trainer device
Conventional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fracture - Lateral Malleolus focused on measuring ankle fracture, rehabilitation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ankle trainer device
Conventional physiotherapy
Arm Description
The patients were instructed in the use of a new spring loaded ankle trainer
The patients were instructed in passive stretching exercises by the use of a non-elastic band
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual analog scale for pain (VAS)
Describes pain on a 0-10 scale with 0 representing no pain, and 10 the worst imaginable pain
Ankle range of motion
Ankle dorsiflexion measured am Lindsjø
Full Information
NCT ID
NCT04168307
First Posted
November 15, 2019
Last Updated
November 16, 2019
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04168307
Brief Title
Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation.
Official Title
Conventional Physiotherapy Versus Use of a New Ankle Trainer Device After Weber b Ankle Fracture Operation. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 29, 2014 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture - Lateral Malleolus, Post-Op Complication
Keywords
ankle fracture, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The physiotherapist conducting follow ups at 6, 12 and 52 weeks was masked for group affiliation
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ankle trainer device
Arm Type
Experimental
Arm Description
The patients were instructed in the use of a new spring loaded ankle trainer
Arm Title
Conventional physiotherapy
Arm Type
Active Comparator
Arm Description
The patients were instructed in passive stretching exercises by the use of a non-elastic band
Intervention Type
Device
Intervention Name(s)
Ankle trainer device
Intervention Description
The ankle trainer provides passive stretch in dorsal flexion of the ankle as well as active plantar flexion.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
The patients were instructed in stretching exercises using a non-elastic band
Primary Outcome Measure Information:
Title
Olerud Molander ankle score (OMAS)
Description
A patient related outcome measure that evaluates ankle function on a 0-100 scale. 100 is indicating a perfect result
Time Frame
52 weeks after surgery
Secondary Outcome Measure Information:
Title
Visual analog scale for pain (VAS)
Description
Describes pain on a 0-10 scale with 0 representing no pain, and 10 the worst imaginable pain
Time Frame
52 weeks
Title
Ankle range of motion
Description
Ankle dorsiflexion measured am Lindsjø
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Molund, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no such plan
Learn more about this trial
Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation.
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