Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

Spaarne Gasthuis

Status and phase: Completed; Phase 2

Conditions: Acute Ankle Sprain; Ankle Ligament Rupture; Ankle Injuries

Treatments: Other: Ankle sprain treated with removable ankle support; Other: Functional treatment for ankle sprain using ankle cast

Study type: Interventional

Funder types: Other

Identifiers

NCT01586390

WRAPvsMOK

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

MOK

Experimental group

Description:

Adjustable and removable brace made out of Softcast material

Treatment:

Other: Ankle sprain treated with removable ankle support

WRAP

Active Comparator group

Description:

Softcast ankle cast

Treatment:

Other: Functional treatment for ankle sprain using ankle cast