|- candidate number||6842|
|- NTR Number||NTR2151|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-dec-2009|
|- Secondary IDs||NL 30075.028.09 CCMO|
|- Public Title||ANKLE TRIAL|
|- Scientific Title||ANKLE Treatment after Injuries of the Ankle Ligaments.|
|- ACRONYM||ANKLE TRIAL|
|- hypothesis||No significant difference in results of functional treatment with physical therapy including a form of external support (tape or brace) in comparison with a purely functional treatment strategy with only a physical therapy programme, without any external support device. |
|- Healt Condition(s) or Problem(s) studied||Acute ankle sprain|
|- Inclusion criteria||1. ‘Healthy’ adult patients (age above 18 years), who are able to give Informed Consent;|
2. Acute (less than 24 hours), single sided and first inversion ankle trauma, whereby sprain of the lateral ankle ligaments has been occurred;
3. Sufficient knowledge of the Dutch language;
4. Living nearby the Jeroen Bosch Hospital.
|- Exclusion criteria||1. Drugs- or alcohol addiction or otherwise factors that will influence compliance in a negative way;|
2. Fracture, syndesmosis or medial ligament rupture, arthritis;
3. Recurrent of bilateral ankle sprain;
4. Not ambulant, wheelchair- or bed dependent patients, because of serious neurological diseases or chronically problems of the locomotor system;
5. Any co morbidity that can disturb the ‘normal’ recovery or rehabilitation tendency after ankle sprain, like ipsilateral ankle pathology, like already existing (functional) ankle instability, chondropathy, ankle fractures, connective tissue diseases (like Ehlers-Danlos) or otherwise chronic diseases.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||1-jan-2011|
|- Target number of participants||165|
|- Interventions||1. Pressure bandage and tape, during 2 x 2 weeks;|
2. Pressure bandage and brace (AirLoc®, Bauerfeind), during 4 weeks;
3. No way of external support at all.
Besides all groups will receive a scheme with ankle exercises to improve balance, coordination and strength of the surrounding muscles.
|- Primary outcome||1. Foot and Ankle Outcome Score (FAOS);|
2. Karlsson scoring scale.
|- Secondary outcome||1. FAOS subscales: pain, other symptoms, ADL, sport en recreation, quality of life;|
2. Number of recurrent ankle injuries;
3. VAS satisfaction;
4. Side effects.
|- Timepoints||1. Inclusion: within 24 hours after ankle sprain;|
2. After 5-7 days;
3. After 6 weeks;
4. After 6 months;
5. After 1 year.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| S. Witjes|
|- CONTACT for SCIENTIFIC QUERIES|| S. Witjes|
|- Sponsor/Initiator ||COC / Leerhuis JBZ, Bauerfeind Benelux BV|
(Source(s) of Monetary or Material Support)
|COC / Leerhuis JBZ, Bauerfeind Benelux BV|
|- Brief summary||Objective of the ANKLE TRIAL is to differentiate between results of three types of functional treatment in a profound methodological way, with primary research question: what will be the optimal functional treatment for acute lateral ankle ligament injuries: is there any surplus value of external support devices (tape or brace) in comparison with a purely functional treatment strategy?|
|- Main changes (audit trail)|
|- RECORD||31-dec-2009 - 21-sep-2010|