Clinical trial · Interventional
Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.
NCT01126242CI-TRIAL-00020907completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to compare tape versus semi rigid support versus lace up brace treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost effectiveness. There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the treatment of acute lateral ankle ligament injury at 6 months follow-up.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Grade II and III Acute Lateral Ankle Ligament Injuries | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lace-up brace | Device | — | UNRESOLVED |
| Semi rigid brace | Device | — | UNRESOLVED |
| Tape | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- tape
- description
- Group I will be treated with non-elastic adhesive tape around the affected ankle, applied by the 'van Unen-technique'. This technique is an alternative for the 'Coumans- technique'. The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue. Different materials can be used alone or in combination. The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself. Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity. Taping is a treatment that involves no loss of time, requires no crutches and is not attended with any ultimate impairment of function.
- interventionNames
- Device: Tape
- Device: Semi rigid brace
- Device: Lace-up brace
- type
- ACTIVE_COMPARATOR
- label
- Lace-up brace
- description
- The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe. The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel. Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application. The calcaneus is captured, effectively locking the heel. The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.