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ANKLE TRIAL


- candidate number6842
- NTR NumberNTR2151
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-dec-2009
- Secondary IDsNL 30075.028.09 CCMO
- Public TitleANKLE TRIAL
- Scientific TitleANKLE Treatment after Injuries of the Ankle Ligaments.
- ACRONYMANKLE TRIAL
- hypothesisNo 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) studiedAcute ankle sprain
- Inclusion criteria1. ‘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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2011
- Target number of participants165
- Interventions1. 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 outcome1. Foot and Ankle Outcome Score (FAOS);
2. Karlsson scoring scale.
- Secondary outcome1. FAOS subscales: pain, other symptoms, ADL, sport en recreation, quality of life;
2. Number of recurrent ankle injuries;
3. VAS satisfaction;
4. Side effects.
- Timepoints1. 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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Witjes
- CONTACT for SCIENTIFIC QUERIES S. Witjes
- Sponsor/Initiator COC / Leerhuis JBZ, Bauerfeind Benelux BV
- Funding
(Source(s) of Monetary or Material Support)
COC / Leerhuis JBZ, Bauerfeind Benelux BV
- PublicationsN/A
- Brief summaryObjective 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)
- RECORD31-dec-2009 - 21-sep-2010


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