Randomised Control Trial
The ODFS has completed a Randomised Control Trial (RCT) that showed that chronic stroke patients:
• walked 16% faster with ODFS
• walked with a reduction of effort, as measured by the physiological cost index, of 29%
• showed a reduction in quadriceps spasticity
• showed a reduction in anxiety and depression
•indicated a significant positive cost/benefit from the treatment as measured by QALY analysis (Quality Adjusted Life Years)

The trial results together with case series data from subjects who had MS were presented to the South and West Regional Health Authority Development and Evaluation Committee who recommended the ODFS for use in the UK's National Health Service for patients with upper motor neurone lesions.

Clinical Service Audit
A subsequent audit of clinical service over the first 18 weeks of use confirmed the results of the

original RCT and also showed a significant training effect i.e. an improvement in walking ability when not using the stimulator, in a group of 111 stroke subjects.

Overall, users walked 27% faster when they used the device with a training effect of 14%. In a subgroup of 27 ODFS users walking speed both with and without the device was observed to improve over the first 18 weeks and thereafter remain unchanged. As the ODFS users were an average of 5.4 (sd +/- 10.7) years post stroke, this supports the hypothesis that the training effect observed was due to the use of the stimulator rather than natural recovery following the stroke. In a group of 78 MS subjects, users walked 20% faster when using the device. In a subgroup of 20 MS users, this improved walking speed with the device was shown to also peak at 18 weeks with no significant change from initial values after that time, indicating the ODFS is an effective orthotic device.