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Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586390
First Posted: April 26, 2012
Last Update Posted: April 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Mensch, Spaarne Ziekenhuis
  Purpose

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.


Condition Intervention Phase
Acute Ankle Sprain Ankle Ligament Rupture Ankle Injuries Other: Functional treatment for ankle sprain using ankle cast Other: Ankle sprain treated with removable ankle support Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial

Further study details as provided by Daniel Mensch, Spaarne Ziekenhuis:

Primary Outcome Measures:
  • Functional scores according to Karlsson score [ Time Frame: 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:
  • Pain [ Time Frame: follow-up of 4 months ]
    Measured by Visual analogue scale (1-10)

  • Satisfaction score [ Time Frame: follow-up of 4 months ]
    satisfaction scores with treatment as well as treatment result on scale 1-10


Enrollment: 100
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586390


Locations
Netherlands
Spaarneziekenhuis
Hoofddorp, Netherlands, 2134 TM
Sponsors and Collaborators
Spaarne Gasthuis
Investigators
Principal Investigator: Daniel Mensch, MD Spaarne Gasthuis
  More Information

Responsible Party: Daniel Mensch, MD, Spaarne Ziekenhuis
ClinicalTrials.gov Identifier: NCT01586390     History of Changes
Other Study ID Numbers: WRAPvsMOK
First Submitted: April 23, 2012
First Posted: April 26, 2012
Last Update Posted: April 26, 2012
Last Verified: April 2012

Keywords provided by Daniel Mensch, Spaarne Ziekenhuis:
Ankle Sprain
Ankle Distortion
Functional treatment
Brace treatment

Additional relevant MeSH terms:
Rupture
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries