Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial

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.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries; Acute Ankle Sprain; Ankle Ligament Rupture
• Intervention / Treatment: Other: Ankle sprain treated with removable ankle support; Other: Functional treatment for ankle sprain using ankle cast

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarneziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOK; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	follow-up of 4 months

Collaborators and Investigators

• Sponsor: Spaarne Gasthuis
• Investigators: Principal Investigator: Daniel Mensch, MD, Spaarne Gasthuis

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Ankle Sprain; Functional treatment; Ankle Distortion; Brace treatment
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Rupture; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: WRAPvsMOK