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Search / Trial NCT01126242

Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.

Launched by GELRE HOSPITALS · May 18, 2010

Trial Information

Current as of April 30, 2025

Completed

Keywords

Ankle Ligament Injuries Non Surgical Treatment Tape Brace Orthotic Device Bandage Cost Effectiveness Randomized Trial

ClinConnect Summary

This study is designed as a single blind prospective randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grade II and III acute lateral ankle ligament injuries. The patients will be randomly allocated into one of the three groups. Randomization will be performed by computer. Blinding of patients is not possible, but the observer will be blinded at eight weeks and six months.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients \> 18 years
  • Grade II or III ankle sprains
  • Presentation \< 72 hours after the acute injury
  • Exclusion Criteria:
  • Patients with a history of chronic instability
  • Who had a fracture on X-ray investigation
  • Other injuries or disabilities on the same limb
  • Alcoholism, serious psychiatric and neurological illness
  • Patients with bilaterally sprained ankles
  • Patients with previous surgery on the lateral ankle ligaments
  • Skin diseases where taping is not practicable
  • Patients who are unable to give informed consent
  • Patients who are unable to fill out questionnaires
  • Neuromuscular disorders of the lower extremities
  • Active rheumatoid arthritis
  • Gait disturbances

About Gelre Hospitals

Gelre Hospitals is a leading healthcare institution dedicated to advancing medical research and patient care through rigorous clinical trials. With a commitment to innovation and excellence, Gelre Hospitals collaborates with multidisciplinary teams to explore new treatment modalities and improve health outcomes. The organization prioritizes patient safety and ethical standards, ensuring that all trials are conducted in compliance with regulatory guidelines. By fostering a culture of continuous improvement and collaboration, Gelre Hospitals aims to contribute significantly to the field of medicine and enhance the quality of life for patients.

Locations

Apeldoorn, , Netherlands

Patients applied

0 patients applied

Trial Officials

Eric EJ Raven, MD

Principal Investigator

Gelre Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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