The Genix Clinical Data Management System (CDMS) is being used as the Electronic Data Capture platform for the SCIPA (Spinal Cord Injury and Physical Activity) Hands On clinical trial being undertaken by the University of Melbourne and the Victorian Neurotrauma Initiative.
Loss of hand function is one of the most devastating consequences of tetraplegia because of the severe impact on activities of daily living and the resultant dependency on others. This multi-centre study in 78 participants will measure whether additional hand therapy provided via an electrical stimulator glove and specialised computer workstation improves hand function in people with tetraplegia. This trial is the first of three inter-related trials that will be conducted over the next 3 years.
The second, SCIPA Full On will examine the effects of a 12-week program of exercise for the whole body, including partial body weight-supported treadmill training, functional electrical stimulation (FES) cycling and trunk exercises.
And finally, SCIPA Switch On will examine the effects of an exercise regime which will take place in the acute and sub-acute phases after spinal injury, once patients are stabilised. The program involves the use of an FES cycle, attached to the end of the bed in ICU/Acute wards or attached to a wheelchair in the rehabilitation clinic, to exercise the legs.
The Genix CDMS provides a flexible and cost effective EDC platform that has addressed a number of the existing shortcomings with established EDC offerings. It has streamlined electronic form creation, significantly reduced the overhead associated with the application of cross-form validations and provided unprecedented audit and security features including the ability to playback form contents at any point in its lifecycle. The platform also provides an option for online monitoring and leverages the upgraded forms creation, document assembly, content management, audit and security frameworks developed for version 3.0 of the BPMS.