Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

Phase 2

Completed

• Conditions: Acute Ankle Sprain; Ankle Ligament Rupture; Ankle Injuries
• Interventions: Other: Ankle sprain treated with removable ankle support; Other: Functional treatment for ankle sprain using ankle cast

• Registration Number: NCT01586390
• Lead Sponsor: Spaarne Gasthuis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-04
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-24
• Last Update Submitted: 2012-04-24
• Study First Posted: 2012-04-26
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOK	Ankle sprain treated with removable ankle support	Adjustable and removable brace made out of Softcast material
WRAP	Functional treatment for ankle sprain using ankle cast	Softcast ankle cast

Primary Outcome Measures

Name	Time	Method
Functional scores according to Karlsson score	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.

Secondary Outcome Measures

Name	Time	Method
Pain	follow-up of 4 months	Measured by Visual analogue scale (1-10)
Satisfaction score	follow-up of 4 months	satisfaction scores with treatment as well as treatment result on scale 1-10

Trial Locations

Locations (1)

Spaarneziekenhuis; 🇳🇱 Hoofddorp, Netherlands