Back to resultsFunctional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast
Primary Purpose
Acute Ankle Sprain, Ankle Ligament Rupture, Ankle Injuries
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Functional treatment for ankle sprain using ankle cast
Ankle sprain treated with removable ankle support
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ankle Sprain focused on measuring Ankle Sprain, Ankle Distortion, Functional treatment, Brace treatment
Eligibility Criteria
Inclusion Criteria:
• Grade 2 and 3 acute ankle sprains
Exclusion Criteria:
- history of ankle sprains with persistent instability
- grade I lateral ankle sprains
- ankle fracture
- bilateral ankle sprains
- previous ankle ligament surgery
- neuromuscular disorders of the lower extremities
- rheumatoid arthritis,
- alcoholism,
- serious psychiatric or neurological illness
Sites / Locations
- Spaarneziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MOK
WRAP
Arm Description
Adjustable and removable brace made out of Softcast material
Softcast ankle cast
Outcomes
Primary Outcome Measures
Functional scores according to Karlsson score
The modified KSS gives a score from 0-90 on perceived function of the ankle and foot, divided over eight topics relevant to daily function. The modified KSS at 4 months was the primary endpoint.
Secondary Outcome Measures
Pain
Measured by Visual analogue scale (1-10)
Satisfaction score
satisfaction scores with treatment as well as treatment result on scale 1-10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01586390
Brief Title
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast
Official Title
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaarne Gasthuis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials.
Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ankle Sprain, Ankle Ligament Rupture, Ankle Injuries
Keywords
Ankle Sprain, Ankle Distortion, Functional treatment, Brace treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOK
Arm Type
Experimental
Arm Description
Adjustable and removable brace made out of Softcast material
Arm Title
WRAP
Arm Type
Active Comparator
Arm Description
Softcast ankle cast
Intervention Type
Other
Intervention Name(s)
Functional treatment for ankle sprain using ankle cast
Intervention Description
Functional treatment for ankle sprain using ankle cast
Intervention Type
Other
Intervention Name(s)
Ankle sprain treated with removable ankle support
Intervention Description
Ankle sprain functionally treated with removable and adjustable ankle support
Primary Outcome Measure Information:
Title
Functional scores according to Karlsson score
Description
The modified KSS gives a score from 0-90 on perceived function of the ankle and foot, divided over eight topics relevant to daily function. The modified KSS at 4 months was the primary endpoint.
Time Frame
Follow-up of 4 months
Secondary Outcome Measure Information:
Title
Pain
Description
Measured by Visual analogue scale (1-10)
Time Frame
follow-up of 4 months
Title
Satisfaction score
Description
satisfaction scores with treatment as well as treatment result on scale 1-10
Time Frame
follow-up of 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Grade 2 and 3 acute ankle sprains
Exclusion Criteria:
history of ankle sprains with persistent instability
grade I lateral ankle sprains
ankle fracture
bilateral ankle sprains
previous ankle ligament surgery
neuromuscular disorders of the lower extremities
rheumatoid arthritis,
alcoholism,
serious psychiatric or neurological illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Mensch, MD
Organizational Affiliation
Spaarne Gasthuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaarneziekenhuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast
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