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Below Knee Cast versus Ankle Stirrup Brace for Severe Ankle Sprain: A Randomized Controlled Multicenter Noninferiority Trial

Below Knee Cast versus Ankle Stirrup Brace for Severe Ankle Sprain: A Randomized Controlled Multicenter Noninferiority Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0001839
Enrollment
310
Registered
2016-03-11
Start date
2016-04-04
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Bundang CHA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)from 18 year old to 65 year old age volunteer after acquiring informed consent 2)severe ankle sprain confirmed by sonography

Exclusion criteria

Exclusion criteria: 1)7 or more days after injury 2)other injury(fracture, tendon injury, syndesmosis ligament injury, deltoid ligament injury) 3)diabetic neuropathic arthropathy 4)infection 5)underlying ankle disease(chronic ankle instability, osteoarthritis, recurrent ankle sprain within last 1 year, generalized ligament laxity) 6)obesity(body mass index > 30 or body weight > 100kg) 7)uncooperative patient 8)other inappropriate condition for case selection

Design outcomes

Primary

MeasureTime frame
FAOS(foot and ankle outcome score) quality of ankle function score—

Secondary

MeasureTime frame
100mm VAS(visual analogue scale) pain score;subjective satisfaction;period of return to daily life—

Countries

Korea, Republic of

Contacts

Public ContactYoung Rak Choi

Bundang CHA General Hospital

jeanguy@naver.com+82-31-780-5289

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026