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Clinical Studies

Controlled trial of an ankle support (MalleoTrain) in acute ankle injuries

J. O’Hara MB, J.C. Valle-Jones MRCS, LRCP, H. Walsh MB, BS, H. O’Hara MRCS,
N.B. Davey MB, BS, DA Eng, H. Hopkin-Richards MRCOG and R.M. Butcher BA, MB, Bchirs

Published in British Journal of Sports Medicine, 1992

A randomized, controlled-parallel group trial assessed 14 days use of MalleoTrain in 220 patients (118 MalleoTrain, 102 control group) with clinically and radiologically proven acute ankle injuries.

The MalleoTrain group was instructed to wear the support every day. The control group received standard therapy advice on resting the affected joint and wearing a simple support (such as Tubigrip).

Patients maintained daily records that were received by the investigator two weeks later. At that time, patients were clinically examined and improvement was assessed.

Both groups showed progressive, highly significant improvements during the 14 days of observation, in all cases the improvement being greater in the MalleoTrain group.

There was a consistent trend for fewer symptoms in the MalleoTrain group.

The number of patients able to work normally rose in both groups, the MalleoTrain group higher, the percentage changing from 34% to 83%.

Analgesic consumption fell progressively during the trial in both groups and was consistently lower in the MalleoTrain group.

In all four assessments: pain at rest, pain at night, pain during activity and activity limitation, the MalleoTrain group improvements were more significant than the control group.

Ratings of ‘much better’ or ‘cured’ were seen in 88% of the MalleoTrain patients and only 68% in the control group.

At the end of the trial, 88% in the MalleoTrain group were described as ‘normal’ or ‘near normal’ while this only true for 67% in the control group.

95% of all Malleotrain treated patients commented on MalleoTrain positively.

MalleoTrain resulted in greater and more rapid improvement, significantly so in relation to the majority of assessment criteria. Overall assessments were in favor of MalleoTrain.