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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOK | Experimental | Adjustable and removable brace made out of Softcast material |
|
| WRAP | Active Comparator | Softcast ankle cast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional treatment for ankle sprain using ankle cast | Other | Functional treatment for ankle sprain using ankle cast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Follow-up of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Measured by Visual analogue scale (1-10) | follow-up of 4 months |
| Satisfaction score | satisfaction scores with treatment as well as treatment result on scale 1-10 |
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Inclusion Criteria:
• Grade 2 and 3 acute ankle sprains
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Mensch, MD | Spaarne Gasthuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaarneziekenhuis | Hoofddorp | 2134 TM | Netherlands |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Ankle sprain treated with removable ankle support | Other | Ankle sprain functionally treated with removable and adjustable ankle support |
|
| follow-up of 4 months |