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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01586390

Enrollment

100

Registered

2012-04-26

Start date

2009-06-30

Completion date

2010-12-31

Last updated

2012-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ankle Sprain, Ankle Injuries, Ankle Ligament Rupture

Keywords

Ankle Sprain, Ankle Distortion, Functional treatment, Brace treatment

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.

Interventions

OTHERFunctional treatment for ankle sprain using ankle cast

Functional treatment for ankle sprain using ankle cast

OTHERAnkle sprain treated with removable ankle support

Ankle sprain functionally treated with removable and adjustable ankle support

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026