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Completed

NCT Number: NCT01586390

Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

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.

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Key information

Conditions

Acute Ankle Sprain Ankle Injuries Ankle Ligament Rupture Leg Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spaarneziekenhuis

Hoofddorp, 2134 TM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional treatment for ankle sprain using ankle cast

Other

Functional treatment for ankle sprain using ankle cast

Ankle sprain treated with removable ankle support

Other

Ankle sprain functionally treated with removable and adjustable ankle support

Primary outcomes

  1. 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 outcomes

  1. Pain

    Time frame: follow-up of 4 months

    Measured by Visual analogue scale (1-10)

  2. Satisfaction score

    Time frame: follow-up of 4 months

    satisfaction scores with treatment as well as treatment result on scale 1-10

Sponsors and collaborators

Lead sponsor

Spaarne Gasthuis

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2012
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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