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Braces versus proprioceptive exercise for the secondary prevention of ankle sprains; a randomised controlled trial and cost-effectiveness evaluation.

Braces versus proprioceptive exercise for the secondary prevention of ankle sprains; a randomised controlled trial and cost-effectiveness evaluation. - ABBA 3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34759
Enrollment
357
Registered
2010-03-25
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

acute lateral ankle ligament injury ankle sprain

Interventions

Subjects allocated to either the *usual care* or brace group will receive an Aircast A60 ankle brace. They will be strongly advised to wear this ankle brace during competition, as in the current rul

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. sustained an acute lateral ankle ligament injury within 4 weeks before inclusion 2. are currently being (para)medically treated for that acute lateral ankle ligament injury

Exclusion criteria

Exclusion criteria: Patients with an ankle fracture are excluded

Design outcomes

Primary

MeasureTime frame
The primary outcome measures will be incidence of ankle sprain recurrences. An economic evaluation will determine and compare the total costs for subjects in all four trial arms, and to relate these costs to the effects of these groups. The economic evaluation will be performed alongside the randomised controlled trial and from a societal perspective.

Secondary

MeasureTime frame
Secondary outcome measures include recurrence severity, residual complaints, and knowledge and attitude regarding the prevention of ankle sprain recurrences.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)