Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

NCT ID: NCT01586390

Last Updated: 2012-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ankle Sprain Ankle Ligament Rupture Ankle Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MOK

Adjustable and removable brace made out of Softcast material

Group Type EXPERIMENTAL

Ankle sprain treated with removable ankle support

Intervention Type OTHER

Ankle sprain functionally treated with removable and adjustable ankle support

WRAP

Softcast ankle cast

Group Type ACTIVE_COMPARATOR

Functional treatment for ankle sprain using ankle cast

Intervention Type OTHER

Functional treatment for ankle sprain using ankle cast

Interventions

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Functional treatment for ankle sprain using ankle cast

Functional treatment for ankle sprain using ankle cast

Intervention Type OTHER

Ankle sprain treated with removable ankle support

Ankle sprain functionally treated with removable and adjustable ankle support

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spaarne Gasthuis

OTHER

Sponsor Role lead

Responsible Party

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Daniel Mensch

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Mensch, MD

Role: PRINCIPAL_INVESTIGATOR

Spaarne Gasthuis

Locations

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Spaarneziekenhuis

Hoofddorp, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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WRAPvsMOK

Identifier Type: -

Identifier Source: org_study_id

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