Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Mensch, Spaarne Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01586390
First received: April 23, 2012
Last updated: April 24, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial

Resource links provided by NLM:


Further study details as provided by Spaarne Ziekenhuis:

Primary Outcome Measures:
  • Functional scores according to Karlsson score [ Time Frame: Follow-up of 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by Visual analogue scale (1-10)

  • Satisfaction score [ Time Frame: follow-up of 4 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586390

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

No publications provided

Responsible Party: Daniel Mensch, MD, Spaarne Ziekenhuis
ClinicalTrials.gov Identifier: NCT01586390     History of Changes
Other Study ID Numbers: WRAPvsMOK
Study First Received: April 23, 2012
Last Updated: April 24, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on August 28, 2014