Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast
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|ClinicalTrials.gov Identifier: NCT01586390|
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : April 26, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Ankle Sprain Ankle Ligament Rupture Ankle Injuries||Other: Functional treatment for ankle sprain using ankle cast Other: Ankle sprain treated with removable ankle support||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Adjustable and removable brace made out of Softcast material
Other: Ankle sprain treated with removable ankle support
Ankle sprain functionally treated with removable and adjustable ankle support
Active Comparator: WRAP
Softcast ankle cast
Other: Functional treatment for ankle sprain using ankle cast
Functional treatment for ankle sprain using ankle cast
- Functional scores according to Karlsson score [ Time Frame: Follow-up of 4 months ]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.
- Pain [ Time Frame: follow-up of 4 months ]Measured by Visual analogue scale (1-10)
- Satisfaction score [ Time Frame: follow-up of 4 months ]satisfaction scores with treatment as well as treatment result on scale 1-10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586390
|Hoofddorp, Netherlands, 2134 TM|
|Principal Investigator:||Daniel Mensch, MD||Spaarne Gasthuis|