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…
ID
Bron
Verkorte titel
Aandoening
Acute ankle sprain
Enkelbandletsel
Ondersteuning
Postbus 90153
5200 ME 's-Hertogenbosch
h.hoekstra@jbz.nl
Bauerfeind Benelux BV
Waarderveldweg 1
2031 BK Haarlem
j.p.van.ede@bauerfeind.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Foot and Ankle Outcome Score (FAOS);<br>
2. Karlsson scoring scale.
Achtergrond van het onderzoek
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?
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2035 |
| NTR-old | NTR2151 |
| CCMO | NL30075.028.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36600 |